Background The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. Methods A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of (...) test results. Results Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. Conclusion H3Africa research makes use of three consent models—specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa. (shrink)

BackgroundCommunity engagement within biomedical research is broadly defined as a collaborative relationship between a research team and a group of individuals targeted for research. A Community Advisory Board is one mechanism of engaging the community. Within genomics research CABs may be particularly relevant due to the potential implications of research findings drawn from individual participants on the larger communities they represent. Within such research, CABs seek to meet instrumental goals such as protecting research participants and their community from research-related risks, (...) as well as intrinsic goals such as promoting the respect of participants and their community. However, successful community engagement depends on the degree to which CABs legitimately represent and engage with communities targeted for research. Currently, there is little literature describing the use of CABs in genomics research taking place in developing countries, and even less in the field of genomics research relating to mental illness. The aim of this article is to describe and consider the contributions made by a researcher-driven, population-specific CAB in a genomics of schizophrenia research project taking place in South Africa, from the perspective of the research team.DiscussionFour broad discussion topics emerged during the CAB meetings namely: 1) informed consent procedures, 2) recruitment strategies, 3) patient illness beliefs and stigma experiences, and 4) specific ethical concerns relating to the project. The authors consider these discussions in terms of their contributions to instrumental and intrinsic goals of community engagement.SummaryThe CAB gave valuable input on the consent processes and materials, recruitment strategies and suggested ways of minimizing the potential for stigma and discrimination. All of these contributions were of an instrumental nature, and helped improve the way in which the research took place. In addition, and perhaps more importantly, the CAB made a unique and important contribution relating to intrinsic functions such as promoting the respect and dignity of research participants and their community. This was particularly evident in ensuring sensitivity and respect of the community’s traditional beliefs about schizophrenia and its treatment, and in this way promoting a respectful relationship between the research team and the participants. (shrink)

In this chapter, I consider the prospects for deploying the concept of public reason in settling practical bioethical questions, focusing in particular on entitlements to healthcare. I begin by tracing the origins of the concept of public reason to the aspirations of the liberal political theorist to find a justification for the authority of government, which reconciles a basic belief in the autonomy of the individual with the legitimacy of the coercive institutions that create and govern the public sphere. I (...) then consider how the concept of public reason may be used in order to justify a universal entitlement to healthcare, paying particular attention to the work of Norman Daniels. Finally, I briefly consider the objection that an entitlement to healthcare grounded on such terms is insufficiently robust, because it downplays the values that healthcare encodes. I conclude by reflecting on whether the concept of public reason can be stretched to include a more robust conception of the value of health. (shrink)

Marine ecosystems are under increasing pressure from human activity, yet successful management relies on knowledge. The evidence-based policy (EBP) approach has been promoted on the grounds that it provides greater transparency and consistency by relying on ‘high quality’ information. However, EBP also creates epistemic responsibilities. Decision-making where limited or no empirical evidence exists, such as is often the case in marine systems, creates epistemic obligations for new information acquisition. We argue that philosophical approaches can inform the science-policy interface. Using marine (...) biosecurity examples, we specifically examine the epistemic challenges in the acquisition and acceptance of evidence to inform policy, discussing epistemic due care and biases in consideration of evidence. (shrink)

BackgroundMulti-centre studies generally cost more than single-centre studies because of larger sample sizes and the need for multiple ethical approvals. Multi-centre studies include clinical trials, clinical quality registries, observational studies and implementation studies. We examined the costs of two large Australian multi-centre studies in obtaining ethical and site-specific approvals.MethodsWe collected data on staff time spent on approvals and expressed the overall cost as a percent of the total budget.ResultsThe total costs of gaining approval were 38 % of the budget for (...) a study of 50 centres (mean cost AUD $6960 per site) and 2 % for a study of 11 centres (mean cost AUD $2300 per site). Seventy-five and 90 % of time was spent on repeated tasks, respectively, and many time-consuming tasks, such as reformatting documents, did nothing to improve the study design or participant safety.ConclusionsImprovements have been made to the ethical approval application system, but more gains could be made without increasing risks of harm to research participants. We propose that ethical review bodies and individual sites publish statistics on how long they take to process approvals which could then be nationally benchmarked. (shrink)

Ludwig Wittgenstein’s relation to Gestalt Psychology is typically understood through the lens of his engagement with Wolfgang Köhler’s work. Though valuable, this framing may obscure certain broader points of similarity between Wittgenstein’s methodological approach and the Gestalt school considered as a whole. In what follows I pursue this line of thought by comparing Wittgenstein’s discussion of rule-following in the Philosophical Investigations with Max Wertheimer’s concept of productive thinking. I argue that Wertheimer’s emphasis on the shared and public aspects of Gestalt (...) phenomena counteracts Köhler’s tendency to characterise Gestalts as essentially private entities. I suggest that in this respect at least, Wertheimer’s approach is closer than Köhler’s to Wittgenstein’s later philosophical orientation. (shrink)

Jecker and Au’s paper raises important issues concerning health equity in pandemic responses, and the importance of considering the long-term effects of pandemic strategy on population health and well-being.1 We welcome their focus on the experience of Asian countries, including Japan. However, we have some concerns with both the distinction which they draw between elimination and mitigation, and their account of the nature and origins of the Japanese response to the COVID-19 pandemic. First, we believe that the distinction between elimination (...) and mitigation is not fine grained enough to capture the various strategies which countries have taken towards the pandemic. Many of Jecker and Au’s criticisms of the elimination strategy relate to specific policies such as lockdowns, travel restrictions and restrictions on businesses, which have been employed by numerous countries irrespective of their end goal. By contrast to the simple elimination/mitigation dichotomy with which Jecker and Au work, Baker et al have identified five separate COVID-19 strategies, namely: exclusion, elimination, suppression, mitigation and no substantive strategy.2 Baker et al define an elimination strategy as ‘maximum action to exclude disease and eliminate community transmission’ with the goal of reaching ‘zero [disease] transmission in the community’. On this account, Japan’s strategy does …. (shrink)

This book explores and elaborates three theories of public reason, drawn from Rawlsian political liberalism, natural law theory, and Confucianism. Drawing together academics from these separate approaches, the volume explores how the three theories critique each other, as well as how each one brings its theoretical arsenal to bear on the urgent contemporary debate of medical assistance in dying. The volume is structured in two parts: an exploration of the three traditions, followed by an in-depth overview of the conceptual and (...) historical background. In Part I, the three comprehensive opening chapters are supplemented by six dynamic chapters in dialogue with each other, each author responding to the other two traditions, and subsequently reflecting on the possible deficiencies of their own theories. The chapters in Part II cover a broad range of subjects, from an overview of the history of bioethics to the nature of autonomy and its status as a moral and political value. In its entirety, the volume provides a vibrant and exemplary collaborative resource to scholars interested in the role of public reason and its relevance in bioethical debate. (shrink)

It is argued that de Vries did not see Mendel's paper until 1900, and that, while his own theory of inheritance may have incorporated the notion of independent units, this pre-Mendelian formulation was not the same as Mendel's since it did not apply to paired hereditary units. Moreover, the way in which the term ‘segregation’ has been applied in the secondary literature has blurred the distinction between what is explained and the law which facilitates explanation.

Motivation has been the subject of much research in the sport psychology literature, whereas athlete mental health has received limited attention. Motivational complexities in elite sport are somewhat reflected in the mental health literature, where there is evidence for both protective and risk factors for athletes. Notably, few studies have linked motivation to mental health. Therefore, the key objective of this study was to test four mental health outcomes in the motivational sequence posited by the Hierarchical Model of Intrinsic and (...) Extrinsic Motivation: motivational climate  basic psychological needs  motivation  mental health outcomes. Elite team-sport athletes (140 females, 75 males) completed seven psychometric inventories of motivation-related and mental health variables. Overall, the athletes reported positive motivational patterns, with autonomous motivation and task climate being more prevalent than their less adaptive counterparts. Elevated depressive symptoms and poor sleep quality affected nearly half of the cohort. Structural equation modelling supported pathways between motivational climate, basic needs, motivation, and mood, depressive symptoms, sleep quality, and trait anxiety. Specifically, a task climate was positively associated with the three basic psychological needs, and an ego climate was positively associated with competence. Autonomy and relatedness had positive and negative associations with autonomous and controlled forms of motivation, respectively. Controlled motivation regulations were positively associated with the four mental health outcomes. Integrated regulation had a negative association with anxiety, and intrinsic regulation had a positive association with depressive symptoms. These findings highlight the complexities of and interrelations between motivation and mental health among athletes, and support the importance of considering mental health as an outcome of motivation. (shrink)

Framed within theories of fairness and stress, the current paper examines bystanders’ intervention intention to workplace bullying across two studies based on international employee samples (N = 578). Using a vignette-based design, we examined the role of bullying mode (offline vs. online), bullying type (personal vs. work-related) and target closeness (friend vs. work colleague) on bystanders’ behavioural intentions to respond, to sympathise with the victim (defender role), to reinforce the perpetrator (prosecutor role) or to be ambivalent (commuter role). Results illustrated (...) a pattern of the influence of mode and type on bystander intentions. Bystanders were least likely to support the victim and more likely to agree with perpetrator actions for cyberbullying and work-related acts. Tentatively, support emerged for the effect of target closeness on bystander intentions. Although effect sizes were small, when the target was a friend, bystanders tended to be more likely to act and defend the victim and less likely to reinforce the perpetrator. Implications for research and the potential for bystander education are discussed. (shrink)

Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claims that placebo-controlled surgical trials are inherently unethical. On the other hand, without placebo-controlled surgical trials, it may be impossible to know whether an apparent benefit from surgery is due to the intervention itself or to the placebo effect.

Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially (...) in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. Semi-structured interviews with key stakeholders, across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications. (shrink)

Cell line immortalisation is a growing component of African genomics research and biobanking. However, little is known about the factors influencing consent to cell line creation and immortalisation in African research settings. We contribute to addressing this gap by exploring three questions in a sample of Xhosa participants recruited for a South African psychiatric genomics study: First, what proportion of participants consented to cell line storage? Second, what were predictors of this consent? Third, what questions were raised by participants during (...) this consent process? 760 Xhose people with schizophrenia and 760 controls were matched to sex, age, level of education and recruitment region. We used descriptive statistics to determine the proportion of participants who consented to cell line creation and immortalization. Logistic regression methods were used to examine the predictors of consent. Reflections from study recruiters were elicited and discussed to identify key questions raised by participants about consent. Approximately 40% of participants consented to cell line storage. The recruiter who sought consent was a strong predictor of participant’s consent. Participants recruited from the South African Eastern Cape, and older participants, were more likely to consent; both these groups were more likely to hold traditional Xhosa values. Neither illness nor education were significant predictors of consent. Key questions raised by participants included two broad themes: clarification of what cell immortalisation means, and issues around individual and community benefit. These findings provide guidance on the proportion of participants likely to consent to cell line immortalisation in genomics research in Africa, and reinforce the important and influential role that study recruiters play during seeking of this consent. Our results reinforce the cultural and contextual factors underpinning consent choices, particularly around sharing and reciprocity. Finally, these results provide support for the growing literature challenging the stigmatizing perception that people with severe mental illness are overly vulnerable as a target group for heath research and specifically genomics studies. (shrink)

Ethical review systems need to build on their experiences of COVID-19 research to enhance their preparedness for future pandemics. Recommendations from representatives from over twenty countries include: improving relationships across the research ecosystem; demonstrating willingness to reform and adapt systems and processes; and making the case robustly for better resourcing.

In a series of articles Christopher Cowie has provided what he calls a ‘Master Argument’ against the Companions in Guilt (CG) defence of moral objectivity. In what follows I defend the CG strategy against Cowie. I show, firstly, that epistemic judgements are relevantly similar to moral judgements, and secondly, that it is not possible coherently to deny the existence of irreducible and categorically normative epistemic reasons. My argument for the second of these claims exploits an analogy between the thesis that (...) epistemic norms are non-categorical and G.E. Moore’s paradox concerning first personal belief ascriptions. I argue that the absurdity of the assertion “I have evidence that p but no reason to believe it” shows that the norms of belief are categorical. I then consider the counter-argument that this categoricity is a ‘conceptual’ rather than an ‘objective’ requirement. By drawing on the work of Hilary Putnam and Charles Travis, I show that this counter-argument is unsuccessful. Putnam is one of the original proponents of the Companions in Guilt strategy. Thus, by supporting the CG argument through appeal to other Putnamian theses, I show that its insights can only fully be appreciated in the context of broader metaphysical and semantic lessons. (shrink)

[Multiple authors] In this paper, we propose a general architecture that is based on fast/slow solvers and a metacognitive component. We then present experimental results on the behavior of an instance of this architecture, for AI systems that make decisions about navigating in a constrained environment. We show how combining the fast and slow decision modalities allows the system to evolve over time and gradually pass from slow to fast thinking with enough experience, and that this greatly helps in decision (...) quality, resource consumption, and efficiency. (shrink)

Recently, shifting societal attitudes towards animals have resulted in an increasing challenge to the ‘social license’ to use animals in competitive sport. Against that background, this paper explores whether the use of animals in competitive sport is ever justifiable from the perspective of three commonly used ethical theories: deontology, utilitarianism and virtue ethics. In so doing, it recognises the importance of human understanding of animals as sentient beings. The author argues that when deontology, utilitarianism and virtue ethics are each used (...) to consider the question ‘Is the use of animals in sport ethically justifiable?’, only absolutist rights theory leads to a negative conclusion. Specified rights theory, utilitarianism and virtue ethics all allow for the human use of animals in sport. However, the author then goes onto argue that even if one does not accept an absolutist rights point of view and does believe that the use of animals in sport is generally ethically justifiable, that use should be limited by fulfilment of certain ‘qualifying constraints’: (a) minimisation of negative welfare effects and maximisation of positive welfare effects, to enable ‘good lives’ for animals (b) identification of and mitigation against avoidable, unnecessary risk and (c) compliance with governing body regulations and the law. (shrink)

Throughout his career, Wittgenstein was preoccupied with issues in the philosophy of perception. Despite this, little attention has been paid to this aspect of Wittgenstein's work. This volume redresses this lack, by bringing together an international group of leading philosophers to focus on the impact of Wittgenstein's work on the philosophy of perception. The ten specially commissioned chapters draw on the complete range of Wittgenstein's writings, from his earliest to latest extant works, and combine both exegetical approaches with engagements with (...) contemporary philosophy of mind. Topics covered include: perception and judgement in the _Tractatus _ aspect-perception the putative intentionality of perception representationalism. The book also includes an overview which summarises the evolution of Wittgenstein's views on perception throughout his life. With an outstanding array of contributors, _Wittgenstein and Perception_ is essential reading for students and scholars of Wittgenstein’s work, as well as those working in philosophy of mind and philosophy of perception. Contributors: Yasuhiro Arahata, Michael Campbell, William Child, Daniel Hutto, Michael O’Sullivan, Marie McGinn, Michel terHark, Charles Travis, and José Zalabardo. (shrink)

Procurement of organs from non-heart-beating cadaver donors raises concerns. Standards for optimal patient care during withdrawal of life-sustaining therapy are evolving and continue to be debated and studied. Consensus on specific procedures and methods has not been attained, however, and protocols for the procurement of organs from patients following the withdrawal of life-sustaining therapies may compromise the evolving standards and harm the patient and the attendant family. In addition, there is little evidence to suggest that such protocols will significantly increase (...) the number of organs procured. "Non-heart-beating cadaver" protocols that do not give comprehensive attention to optimal patient/family care at the time of withdrawal of life-sustaining therapy ought not to be endorsed. (shrink)

Carter argues that Wittgensteinian moral philosophy – typified by the work of Raimond Gaita and Christopher Cordner – rests on shaky foundations because it vacillates between grounding moral judgements in grammar and in a form of life. In this article, I respond to Carter's criticism. I defend Wittgensteinian moral philosophy by showing that Gaita and Cordner specifically repudiate the purported dichotomy between grammar and a form of life. I then go on to explain why Wittgensteinian moral philosophers are right not (...) to try to ground moral judgements in features of a shared form of life. (shrink)

Community engagement has been recognised as an important aspect of the ethical conduct of biomedical research, especially when research is focused on ethnically or culturally distinct populations. While this is a generally accepted tenet of biomedical research, it is unclear what components are necessary for effective community engagement, particularly in the context of genomic research in Africa.

Ethical decision-making in public health rarely involves simply avoiding a bad choice in favor of a good choice. Instead, it requires policymakers to strike a balance among conflicting goals that are all good—goals such as the health of populations and individuals, knowledge gained through scientific research, autonomy, social justice, and the efficient use of limited resources. This balance can be elusive, and perfect examples are the legal instruments governing dual-use research, a term describing scientific endeavors meant to produce beneficial knowledge (...) or technology, but that could also be misapplied. Dual-use research of concern policies were implemented... (shrink)

IntroductionKraut defines absolute goodness as follows: for something to be absolutely good is for its goodness to be unrelated to the needs or interests of any individual.See Richard Kraut, Against Absolute Goodness , pp. 4ff. Let’s allow goodness to apply broadly to objects, states of affairs and events . Treat x as a variable ranging over these categories. Then, to say that x is absolutely good in this sense is to say that a world containing x is better than a (...) world in which x is absent, whether or not x contributes, in that world, to the satisfaction of anyone’s needs or interests. For example, to say that the Bamiyan Buddhas are absolutely good is to claim that a world in which all sentient life has be .. (shrink)

Or future of Professor Skutsch , 60, 378), calling the contraction ‘impossible’ , insists on the latter; F. Vian in his Bude Apollonius leaves the question open. A.R.1.685 ~ 693.

Or future of Professor Skutsch, 60, 378), calling the contraction ‘impossible’, insists on the latter; F. Vian in his Bude Apollonius leaves the question open. A.R.1.685 ~ 693.