Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

abstractBackground: Evidence shows both a tendency for research participants to conflate research and clinical care and a limited public understanding of research. Conflation of research and care by participants is often referred to as the therapeutic misconception. Despite this evidence, few studies have explicitly asked participants, and especially minors, to explain what they think research is and how they think it differs from regular medical care. Methods: As part of a longer semistructured interview evaluating assent and parental permission for research, (...) adolescent research participants (n = 177), including adolescents with illnesses and healthy volunteers, and their parents (n = 177) were asked to describe medical research in their own words and say whether and how they thought being in medical research was different from seeing a regular doctor. Qualitative responses were coded and themes were identified through an iterative process. Results: When asked to describe medical research, the majority described research in terms of its goals of helping to advance science, develop treatments and medicines, and help others; fewer described research as having the goal of helping particular research participants, and fewer still in terms of the methods used in research. The majority of teen and parent respondents said being in research is different than seeing a regular doctor and explained this by describing different goals, different or more procedures, differences in the engagement of the doctors/researchers, and differences in logistics. Conclusions: Adolescents participating in clinical research and their parents generally describe medical research in terms of its goals of advancing science and finding new medicines and treatments, sometimes in combination with helping the enrolled individuals. The majority perceive a difference between research and regular medical care and described these differences in various ways. Further exploration is warranted about how such perceived differences matter to participants and how this understanding could be used to enhance informed consent and the overall research experience. (shrink)

New fetal therapies offer important prospects for improving health. However, having to consider both the fetus and the pregnant woman makes the risk–benefit analysis of fetal therapy trials challenging. Regulatory guidance is limited, and proposed ethical frameworks are overly restrictive or permissive. We propose a new ethical framework for fetal therapy research. First, we argue that considering only biomedical benefits fails to capture all relevant interests. Thus, we endorse expanding the considered benefits to include evidence-based psychosocial effects of fetal therapies. (...) Second, we reject the commonly proposed categorical risk and/or benefit thresholds for assessing fetal therapy research. Instead, we propose that the individual risks for the pregnant woman and the fetus should be justified by the benefits for them and the study’s social value. Studies that meet this overall proportionality criterion but have mildly unfavorable risk–benefit ratios for pregnant women and/or fetuses may be acceptable. (shrink)

Objective Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings. Methods We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents of paediatric participants (...) in actual trials, assessed comprehension and/or voluntariness, and did not involve testing particular consent interventions. Forty-seven studies met these criteria. We compared data about participant comprehension and voluntariness. The paucity of data and variation in study methodology limit comparison and preclude statistical aggregation of the data. Results and Discussion This review shows that the assertion that informed consent is worse in developing countries than in developed countries is a simplification of a complex picture. Despite the limitations of comparison, the data suggest that: (1) comprehension of study information varies among participants in both developed and developing countries, and comprehension of randomisation and placebo controlled designs is poorer than comprehension of other aspects of trials in both settings; and (2) participants in developing countries appear to be less likely than those in developed countries to say they can refuse participation in or withdraw from a trial, and are more likely to worry about the consequences of refusal or withdrawal. (shrink)

Research ethics consultation is increasingly recognized as a potentially valuable mechanism for addressing the depth and breadth of ethical issues that arise in research related to human health and well-being. However, fundamental questions remain, including: What is “research ethics consultation”? And what is its justification beyond the purposes already served by existing entities? We examine how a research ethics consultation service may differ from or complement the role of an institutional review board by offering a definition of research ethics consultation (...) and by exploring the potential scope of a consultation service in terms of types of clients served, questions addressed, and advice provided at various stages of the research process. We then consider the relationship between research ethics consultation services and IRBs, as well as the issues that may arise between them, including possible conflicts of interest. (shrink)

New fetal therapies offer important prospects for improving health. However, having to consider both the fetus and the pregnant woman makes the risk–benefit analysis of fetal therapy trials challenging. Regulatory guidance is limited, and proposed ethical frameworks are overly restrictive or permissive. We propose a new ethical framework for fetal therapy research. First, we argue that considering only biomedical benefits fails to capture all relevant interests. Thus, we endorse expanding the considered benefits to include evidence-based psychosocial effects of fetal therapies. (...) Second, we reject the commonly proposed categorical risk and/or benefit thresholds for assessing fetal therapy research. Instead, we propose that the individual risks for the pregnant woman and the fetus should be justified by the benefits for them and the study’s social value. Studies that meet this overall proportionality criterion but have mildly unfavorable risk–benefit ratios for pregnant women and/or fetuses may be acceptable. (shrink)

Existing research on the formation of employee ethical climate perceptions focuses mainly on organization characteristics as antecedents, and although other constructs have been considered, these constructs have typically been studied in isolation. Thus, our understanding of the context in which ethical climate perceptions develop is incomplete. To address this limitation, we build upon the work of Rupp to develop and test a multi-experience model of ethical climate which links aspects of the corporate social responsibility, ethics, justice, and trust literatures and (...) helps to explain how employees’ ethical climate perceptions form. We argue that in forming ethical climate perceptions, employees consider the actions or characteristics of a complex web of actors. Specifically, we propose that employees look outward at how communities are impacted by their organization’s actions, upward to make inferences about the ethicality of leaders in their organizations, and inward at their own propensity to trust others as they form their perceptions. Using a multiple-wave field study conducted at a privately held US corporation, we find substantial evidence in support of our model. (shrink)

This article is currently available as a free download on ingentaconnect.

This article is currently available as a free download on ingentaconnect.

This article is currently available as a free download on ingentaconnect.

The recent Common Rule revision process took almost a decade and the resulting changes are fairly modest, particularly when compared to the ambitious ideas proposed in the advance notice of proposed rulemaking and notice of proposed rulemaking. Furthermore, the revision process did not even attempt to tackle any of the Common Rule subparts pertaining to vulnerable populations where commentators think the rules unduly restrict important research. We believe that this was a missed opportunity to make desirable changes, and that given (...) the usual process the next opportunity to revisit the Common Rule is unacceptably remote. In this article, we argue that the Common Rule should be regularly reassessed, with a mechanism for making substantive changes. Drawing on lessons learned from the recent revision process, we make recommendations about ways to structure future attempts to maximize the ability to make timely and necessary changes. (shrink)

Interacting with others frequently involves making common-sense inferences linking context, background knowledge, and beliefs to utterances in the dialogue. As language users we are generally good at this kind of dialogical reasoning, and might not even be aware we are involved in it while we engage in a conversation. However, sometimes it is not obvious how a particular contribution should be interpreted in terms of the underpinning assumptions warranting an inference. In dialogue involving participants who demonstrate atypical linguistic behavior, such (...) as patients with schizophrenia, the effects may be even more marked. (shrink)

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

This volume presents the concept of Ecoscape as spatial interrelations, or spatially patterned processes, that are constitutive of an environment_an ecosystem. Contributors investigate environmental issues concerning the human impact on geohistory, food distribution, genetically modified biota, waste management, scientific mapping, and the rethinking of human identity.

After decades of single issue movements and identity politics on the U.S. left, the series of large demonstrations beginning in 1999 in Seattle have led many to wonder if activist politics can now come together around a common theme of global justice. This book pursues the prospects for progressive political movements in the 21st century with case studies of ten representative movements, including the anti-globalization forces, environmental interest groups, and new takes on the peace movement.

Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of human (...) subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research. (shrink)

Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of human (...) subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research. (shrink)

In this review, we describe some of the central philosophical issues facing origins-of-life research and provide a targeted history of the developments that have led to the multidisciplinary field of origins-of-life studies. We outline these issues and developments to guide researchers and students from all fields. With respect to philosophy, we provide brief summaries of debates with respect to (1) definitions (or theories) of life, what life is and how research should be conducted in the absence of an accepted theory (...) of life, (2) the distinctions between synthetic, historical, and universal projects in origins-of-life studies, issues with strategies for inferring the origins of life, such as (3) the nature of the first living entities (the “bottom up” approach) and (4) how to infer the nature of the last universal common ancestor (the “top down” approach), and (5) the status of origins of life as a science. Each of these debates influences the others. Although there are clusters of researchers that agree on some answers to these issues, each of these debates is still open. With respect to history, we outline several independent paths that have led to some of the approaches now prevalent in origins-of-life studies. These include one path from early views of life through the scientific revolutions brought about by Linnaeus (von Linn.), Wöhler, Miller, and others. In this approach, new theories, tools, and evidence guide new thoughts about the nature of life and its origin.We also describe another family of paths motivated by a” circularity” approach to life, which is guided by such thinkers as Maturana & Varela, Gánti, Rosen, and others. These views echo ideas developed by Kant and Aristotle, though they do so using modern science in ways that produce exciting avenues of investigation. By exploring the history of these ideas, we can see how many of the issues that currently interest us have been guided by the contexts in which the ideas were developed. The disciplinary backgrounds of each of these scholars has influenced the questions they sought to answer, the experiments they envisioned, and the kinds of data they collected. We conclude by encouraging scientists and scholars in the humanities and social sciences to explore ways in which they can interact to provide a deeper understanding of the conceptual assumptions, structure, and history of origins-of-life research. This may be useful to help frame future research agendas and bring awareness to the multifaceted issues facing this challenging scientific question. (shrink)

In this paper we treat humorous situations as a series of events underpinned by topoi, principles of reasoning recognised within a socio-cultural community. We claim that humorous effect in jokes and other discourse is often created by the juxtaposition of topoi evoked. A prerequisite for this is that there is a shift where the interpreter of the discourse updates their information state with regard to a second topos being evoked. This view of humour is consistent with an incremental analysis of (...) dialogue, and we therefore argue that interaction is central both for humour creation and interpretation. We point out some different ways in which topoi are juxtaposed in humorous dialogues as well as in jokes published in social media or in joke books, and take jokes from the coronavirus pandemic as an example because this makes lots of new topoi available and therefore offers the opportunity of creating novel jokes based on the juxtaposition of the new and existing topoi. We explore how the mechanisms of inference in dialogue can be applied to humour through the four elements from our title: old, new, borrowed and taboo. (shrink)

In this study, we comprehensively examine the relationships between ethical leadership, social exchange, and employee commitment. We find that organizational and supervisory ethical leadership are positively related to employee commitment to the organization and supervisor, respectively. We also find that different types of social exchange relationships mediate these relationships. Our results suggest that the application of a multifoci social exchange perspective to the context of ethical leadership is indeed useful: As hypothesized, within-foci effects (e.g., the relationship between organizational ethical leadership (...) and commitment to the organization) are stronger than cross-foci effects (e.g., the relationship between supervisory ethical leadership and commitment to the organization). In addition, in contrast to the “trickle down” model of ethical leadership (Mayer et al. in Org Behav Hum Decis Process 108:1–13, 2009), our results suggest that organizational ethical leadership is both directly and indirectly related to employee outcomes. (shrink)

Ample research links mothers’ postpartum depression (PPD) to adverse interactions with their infants. However, most studies relied on general population samples, whereas a substantial number of women are at elevated depression risk. The purpose of this study was to describe mothers’ interactions with their 6- and 12-month-old infants among women at elevated risk, although with a range of symptom severity. We also identified higher-order factors that best characterized the interactions and tested longitudinal consistency of these factors from 6 to 12 (...) months of infant age. We leveraged data from eight projects across the United States (n = 647), using standardized depression measures and an adaptation of the NICHD Mother-Infant Interaction Scales. Overall, these depression-vulnerable mothers showed high levels of sensitivity and positive regard and low levels of intrusiveness, detachment, and negative regard with their infants. Factor analyses of maternal behaviors identified two overarching factors—“positive engagement” and “negative intrusiveness” that were comparable at 6 and 12 months of infant age. Mothers’ ability to regulate depressed mood was a key behavior that defined “positive engagement” in factor loadings. An exceptionally strong loading of intrusiveness on the second factor suggested its central importance for women at elevated depression risk. Mothers with severe depressive symptoms had significantly more “negative intrusiveness” and less “positive engagement” with their 6-month-old infants than women with moderate or fewer depressive symptoms, suggesting a potential tipping point at which symptoms may interfere with the quality of care. Results provide the foundation for further research into predictors and moderators of women’s interactions with their infant among women at elevated risk for PPD. They also indicate a need for evidence-based interventions that can support more severely depressed women in providing optimal care. (shrink)

This book evaluates the major debates around which the discipline of international relations has developed in the light of contemporary feminist theories. The three debates (realist versus idealist, scientific versus traditional, modernist versus postmodernist) have been subject to feminist theorising since the earliest days of known feminist activities, with the current emphasis on feminist, empiricist standpoint and postmodernist ways of knowing. Christine Sylvester shows how feminist theorising could have affected our understanding of international relations had it been included in (...) the three debates. She elaborates a feminist method of empathetically cooperative conversation which challenges the identity politics of IR, and illustrates that method with reference to the Greenham Common Women's Peace Camp and the efforts of Zimbabwean women to negotiate international funding for their local producer cooperatives. (shrink)

The punishment of social misconduct is a powerful mechanism for stabilizing high levels of cooperation among unrelated individuals. It is regularly assumed that humans have a universal disposition to punish social norm violators, which is sometimes labelled “universal structure of human morality” or “pure aversion to social betrayal”. Here we present evidence that, contrary to this hypothesis, the propensity to punish a moral norm violator varies among participants with different career trajectories. In anonymous real-life conditions, future teachers punished a talented (...) but immoral young violinist: they voted against her in an important music competition when they had been informed of her previous blatant misconduct toward fellow violin students. In contrast, future police officers and high school students did not punish. This variation among socio-professional categories indicates that the punishment of norm violators is not entirely explained by an aversion to social betrayal. We suggest that context specificity plays an important role in normative behaviour; people seem inclined to enforce social norms only in situations that are familiar, relevant for their social category, and possibly strategically advantageous. (shrink)

La pensée de Walter Benjamin constitue la tentative aussi lucide que désespérée d’un intellectuel de contrer ce qu’il sait inévitable : la déshumanisation d’un monde dont la tradition et les valeurs culturelles ont été liquidées par l’expérience de la grande guerre et l’avènement de la barbarie fasciste qui fera de l’histoire une catastrophe. Les stratégies politiques et esthétiques que Benjamin développe afin de combattre la menace du fascisme peuvent être résumées sous la notion de « barbar...

Notre contribution montre que malgré l’absence flagrante d’un usage explicite du terme dans la plupart des textes de Benjamin, la problématique de l’authenticité est un des enjeux les plus importants de sa pensée, à la fois comme concept esthétique, mais aussi comme objectif d’une philosophie de la connaissance qui en fait son idéal, tout en le mettant systématiquement en doute. La réflexion sur l’authenticité se décline dans tous les domaines de la pensée benjaminienne : l’art, l’histoire, la politique et (...) la traduction, et figure au cœur du seul texte consacré à la notion, l’essai sur « L’œuvre d’art à l’époque de sa reproductibilité technique » que notre contribution analyse en détail, de façon à mettre en lumière l’ambivalence fondamentale du concept. (shrink)

Numerous studies show that humans tend to be more cooperative than expected given the assumption that they are rational maximizers of personal gain. As a result, theoreticians have proposed elaborated formal representations of human decision-making, in which utility functions including “altruistic” or “moral” preferences replace the purely self-oriented "Homo economicus" function. Here we review mathematical approaches that provide insights into the mathematical stability of alternative ways of representing human decision-making in social contexts. Candidate utility functions may be evaluated with help (...) of game theory, classical modeling of social evolution that focuses on behavioral strategies, and modeling of social evolution that focuses directly on utility functions. We present the advantages of the latter form of investigation and discuss one surprisingly precise result: “Homo economicus” as well as “altruistic” utility functions are less stable than a function containing a preference for the golden rule or for the common welfare that is only expressed in social contexts composed of individuals with similar preferences. We discuss the contribution of mathematical models to our understanding of human other-oriented behavior, with a focus on the classical debate over psychological altruism. We conclude that human can be psychologically altruistic, but that psychological altruism evolved because it was generally expressed towards individuals that contributed to the actor’s fitness, such as own children, romantic partners and long term reciprocators. (shrink)

© 2015, Springer-Verlag Berlin Heidelberg.Genetic studies have identified single nucleotide polymorphisms associated with the risk of prostate cancer. It remains unclear whether such genetic variants are associated with disease aggressiveness. The NCI-SPORE Genetics Working Group retrospectively collected clinicopathologic information and genotype data for 36 SNPs which at the time had been validated to be associated with PC risk from 25,674 cases with PC. Cases were grouped according to race, Gleason score and aggressiveness. Statistical analyses were used to compare the frequency (...) of the SNPs between different disease cohorts. After adjusting for multiple testing, only PC-risk SNP rs2735839 was significantly and inversely associated with aggressive and high-grade disease in European men. Similar associations with aggressive and high-grade disease were documented in African-American subjects. The G allele of rs2735839 was associated with disease aggressiveness even at low PSA levels in both European and African-American men. Our results provide further support that a PC-risk SNP rs2735839 near the KLK3 gene on chromosome 19q13 may be associated with aggressive and high-grade PC. Future prospectively designed, case-case GWAS are needed to identify additional SNPs associated with PC aggressiveness. (shrink)

While stakeholder theory has traditionally considered organization’s interactions with stakeholders in terms of independent, dyadic relationships, recent scholarship has pointed to the fact that organizations exist within a complex network of intertwining relationships [e.g., Rowley, T. J.: 1997, The Academy of Management Review 22(4), 887–910]. However, further theoretical and empirical development of the interactions between stakeholders has been lacking. In this paper, we develop a framework for understanding and measuring the effects upon the organization of competing, complementary and cooperative stakeholder (...) interactions, which we refer to as stakeholder multiplicity. We draw upon three forms of fit (i.e. fit as matching, fit as moderation, and fit as gestalts; Venkatraman, N.: 1989) to develop a framework for understanding stakeholder multiplicity based upon the direction, strength, and synergies of the interacting claims. Additionally, we draw upon the theory of stakeholder identification and salience of Mitchell et al. (1997), which we argue provides a more relevant and significantly more illustrative explanation of the nature and effects of stakeholder interactions upon the organization than the network approach of Rowley (1997). Furthermore, we ground our framework through reference to three stakeholder groups (i.e. governments, customers, and employees) and the stakeholder issue of concern for the natural environment. We propose a hierarchy of the multiplicity strength of influence of these three stakeholder groups. Potential measurement and implications are discussed. (shrink)

The current system of organ procurement which relies on donation is inadequate to the current and future need for transplantable kidneys. The growing disparity between demand and supply is accompanied by a steep human cost. I argue that a regulated market in organs from living vendors is the only plausible solution, and that objections common to opponents of organ markets are defeasible. I argue that a morally defensible market in kidneys from living vendors includes four characteristics: (1) the priority of (...) safety for both vendors and recipients, (2) transparency regarding the risks to vendors and recipients, (3) institutional integrity regarding guidelines for cooperating with kidney vendors, and (4) operation under a rule of law. I conclude with some remarks on remaining problems with this account, and offer some suggestions as to how these problems might be addressed. (shrink)

The possibility of cooperation and the stability of political order are long-standing problems. Polybius, well known for his Histories analysing the expansion of Rome and his description of the Roman constitution, also offers an intriguing social and political theory that covers ground from psycho-anthropological micro-foundations to institution-based political order, providing a genealogy of morals and political order that is best understood in game-theoretical terms. In this paper I try to give such an interpretation. Polybius’ naturalistic, proto-game theoretical views show similarities (...) with Hume, Smith and especially Hobbes’ doctrine of sovereignty by acquisition. However, Polybius is original in crucial regards, giving a motivationally plausible account of institutional and especially constitutional solutions to moral and political problems. Constitutional order, for Polybius, embodies and makes possible in the first place a kind of political reason that cannot be had individually. Polybian political theory thus offers interesting solutions to problems concerning moral motivation, collective action, and the conditions for political order, as well as the explanation and character of institutions. (shrink)

The two main goals of this paper are to question the possibility of the existence of moral emotions and to decipher the notion of moral emotion. I start with a brief critical analysis of various philosophical understandings of moral emotions before setting out an evolutionary line of approach that seems promising at first glance: according to the functional evolutionary approach, moral emotions have the evolutionary function of sustaining cooperation. It turns out ultimately that this approach has its own drawbacks. I (...) finally propose to give up the idea of moral property intrinsic to some emotions; “moral” seems instead merely to label emotions when they occur in morally relevant contexts. (shrink)

In this article, I defend the idea that Bentham's international political theory entails a cosmopolitan dimension. First, I explain that Bentham rejects two pillars of internationalism, namely, the sovereign's unconstrained autonomous power and authority in international politics, and the legal and moral personality of the state in the international realm. This critique leads Bentham to construct a complex international political theory which places the issue of states’ responsibility at its centre. Bentham's international theory articulates a minimalist international system of cooperation (...) between states and an institutional model of public officials’ responsibilities that together play the crucial role in securing the greatest happiness of the greatest number in the world. In this last part, I explain how Bentham's international political theory relies heavily on the responsibilities of states, a set of responsibilities that encompasses both national and cosmopolitan responsibilities that public officials in each state hold. (shrink)