Given ICH-GCP’s role in shaping IRB standards in most jurisdictions, clarifying the function and definition of nonscientific members is crucial. ICH-GCP 3.2.1 requires a nonscientific member but its definition focuses on who they are not rather than who they are, creating ambiguity and varied interpretations. This paper reviews the idea of nonscientific members of the IRB to understand their definitions and roles based on current literature. This is because, despite the ICH-GCP’s mandate, recent research is scarce. Our review identifies that (...) in the current literature, various definitions and roles are ascribed to nonscientific members, resulting in a lack of clarity. Following our thematic analysis, we highlight two main interpretations of the nonscientific member’s definition: one as a distinct perspective from scientific members and another as an embodiment of “ordinariness” to minimize bias. In addition, we also highlight three primary roles: reviewing consent forms, representing public and participant interests, and providing oversight. Some findings may not align with current IRB practices, and without clear definitions, adherence to ICH-GCP guidelines may be inconsistent. (shrink)

In an historic moment in Dutch politics, the entire cabinet left the House of Representatives during a debate due to extreme right politician Thierry Baudet's conspiracy-laden speech. After espousing a variety of conspiratorial claims, Baudet accused the Minister of Finance, Sigrid Kaag, of being a secret agent for a global Deep State since her studies at Oxford. The accusation prompted Kaag and the entire cabinet to exit the chamber. While some MPs defended Baudet's right to speak, others supported the chair's (...) decision to silence him for violating the rules. These events showcase the divisive potential of conspiracy accusations in politics, causing polarised reactions. Our analysis delves into the dynamics of conspiracy accusations, their impact on polarisation, and the role of intended audiences (as opposed to general audiences) in both advancing accusations and shaping responses thereto. We argue that Baudet's tactics aimed at capitalising on the polarisation his accusations generated. We argue further that dismissing conspiracy accusations too hastily can deepen public distrust in elected officials, emphasising the need for caution in handling such claims. Ultimately, we highlight the broader pattern of conspiracy accusations being employed to fuel political polarisation, raising questions about their role in democratic deliberation. (shrink)

Abstract:Open neural tube defects or myelomeningoceles are a common congenital condition caused by failure of closure of the neural tube early in gestation, leading to a number of neurologic sequelae including paralysis, hindbrain herniation, hydrocephalus and neurogenic bowel and bladder dysfunction. Traditionally, the condition was treated by closure of the defect postnatally but a recently completed randomized controlled trial of prenatal versus postnatal closure demonstrated improved neurologic outcomes in the prenatal closure group. Fetal surgery, or more precisely maternal-fetal surgery, raises (...) a number of ethical issues that we address including who the patient is, informed consent, surgical innovation and equipoise as well maternal assumption of risk. As the procedure becomes more widely adopted into practice, we suggest close monitoring of new fetal surgery centers, in order to ensure that the positive results of the trial are maintained without increased risk to both the mother and fetus. (shrink)

While recent studies have claimed that non-referential gestures (i.e., gestures that do not visually represent any semantic content in speech) are used to mark discourse-new and/or -accessible referents and focused information in adult speech, to our knowledge, no prior investigation has studied the relationship between information structure (IS) and gesture referentiality in children’s narrative speech from a developmental perspective. A longitudinal database consisting of 332 narratives performed by 83 children at two different time points in development was coded for IS (...) and gesture referentiality (i.e., referential and non-referential gestures). Results revealed that at both time points, both referential and non-referential gestures were produced more with information that moves discourse forward (i.e., focus) and predication (i.e., comment) rather than topical or background information. Further, at 7–9 years of age, children tended to use more non-referential gestures to mark focus and comment constituents than referential gestures. In terms of the marking of the newness of discourse referents, non-referential gestures already seem to play a key role at 5–6 years old, whereas referential gestures did not show any patterns. This relationship was even stronger at 7–9 years old. All in all, our findings offer supporting evidence that in contrast with referential gestures, non-referential gestures have been found to play a key role in marking IS, and that the development of this relationship solidifies at a period in development that coincides with a spurt in non-referential gesture production. (shrink)

This book examines cultural recognition and the struggle for identity in America's schools. In particular, the contributing authors focus on the recognition and misrecognition as antagonistic cultural forces that work to shape, and at times distort identity.

Significant strides have been made in recent years towards understanding the molecular basis of cell cycle progression in the model bacterium Caulobacter crescentus. At the heart of cell cycle regulation is a multicomponent transcriptional feedback loop, governing the production of successive regulatory waves or pulses of at least three master regulatory proteins. These oscillating master regulators direct the execution of phase‐specific events and, importantly, through intrinsic genetic switches not only determine the length of a given phase, but also provide the (...) driving force that catapults the cell into the next stage of the cell cycle. The genetic switches act as fail safe mechanisms that prevent the cell cycle from relapsing and thus govern the ordered production and the periodicity of these regulatory waves. Here, we detail how the master regulators CtrA, GcrA and DnaA coordinate cell cycle progression and polar development in Caulobacter. BioEssays 28: 355–361, 2006. © 2006 Wiley Periodicals, Inc. (shrink)

Background The rapidly growing quantity of health data presents researchers with ample opportunity for innovation. At the same time, exploitation of the value of Big Data poses various ethical challenges that must be addressed in order to fulfil the requirements of responsible research and innovation (Gerke et al. 2020 ; Howe III and Elenberg 2020 ). Data sovereignty and its principles of self-determination and informed consent are central goals in this endeavor. However, their consistent implementation has enormous consequences for the (...) collection and processing of data in practice, especially given the complexity and growth of data in healthcare, which implies that artificial intelligence (AI) will increasingly be applied in the field due to its potential to unlock relevant, but previously hidden, information from the growing number of data (Jiang et al. 2017 ). Consequently, there is a need for ethically sound guidelines to help determine how data sovereignty and informed consent can be implemented in clinical research. Methods Using the method of a narrative literature review combined with a design thinking approach, this paper aims to contribute to the literature by answering the following research question: What are the practical requirements for the thorough implementation of data sovereignty and informed consent in healthcare? Results We show that privacy-preserving technologies, human-centered usability and interaction design, explainable and trustworthy AI, user acceptance and trust, patient involvement, and effective legislation are key requirements for data sovereignty and self-determination in clinical research. We outline the implications for the development of IT solutions in the German healthcare system. (shrink)

This book returns the reader to an agenda for addressing equity in schools, emphasizing the need to reexamine past reform efforts and the work ahead for educational leaders in reshaping schools and schooling.

Zusammenfassung Hintergrund Die exponentiell wachsende Verfügbarkeit von Gesundheitsdaten bietet Forschenden ungeahnte Potenziale für Innovationen. Gleichzeitig gehen mit der Verwertung von Big Data auch große ethische Herausforderungen einher, die es zu bewältigen gilt, um den Anforderungen an verantwortungsvolle Forschung und Innovation gerecht zu werden (Gerke et al. 2020; Howe III und Elenberg 2020). Datensouveränität und die damit verbundenen Grundsätze der Selbstbestimmung und der informierten Zustimmung sind dabei zentrale Ziele. Allerdings hat deren konsistente Umsetzung enorme Konsequenzen für die Datenerhebung und -verarbeitung in (...) der Praxis. Dies trifft insbesondere angesichts einer Zunahme an Quantität und Komplexität von Daten im Gesundheitswesen zu. Denn aufgrund des Potenzials, relevante aber bisher verborgene Informationen aus der Datenmenge zu erschließen, ist eine zunehmende Anwendung von künstlicher Intelligenz (KI) in diesem Bereich zu erwarten (Jiang et al. 2017). Folglich besteht ein Bedarf an ethisch fundierten Handlungsanweisungen, die helfen, Datensouveränität und informierte Zustimmung in der klinischen Forschung umzusetzen. Material und Methoden Durch Anwendung einer narrativen Literaturrecherche in Kombination mit einem Design-Thinking-Ansatz soll das vorliegende Papier einen Beitrag zur Literatur leisten, indem die folgende Forschungsfrage beantwortet wird: Welche praktischen Anforderungen gibt es für eine konsequente Umsetzung von Datensouveränität und informierter Einwilligung im Gesundheitswesen? Ergebnisse Es wird gezeigt, dass Privatsphäre wahrende Technologien, menschenzentriert entwickelte Nutzungs- und Interaktionslösungen, erklärbare und vertrauenswürdige KI, Nutzerakzeptanz und -vertrauen, Patientenbeteiligung und eine wirksame Gesetzgebung zentrale Voraussetzungen für Datensouveränität und Selbstbestimmung in der klinischen Forschung sind. Die Bedeutung für die Entwicklung von IT-Lösungen im deutschen Gesundheitssystem wird dargelegt. (shrink)

This case study provides a multi-perspective view on the power of political events as a strategy to influence public opinion-building regarding the European Union and the European Idea. To achieve this purpose, it examines one prominent political issue of 2007, namely the German Presidency of the Council of the EU. Looking at three different groups of actors, the German Government, the media, and the audience, the public perception of events is analyzed according to their varying degree of mediatization. The case (...) study compares the three main objectives of the German Presidency on the actors' agendas and describes how issues were framed during three different time periods. The findings suggest that the media agenda was heavily influenced by the government's scheduled events. Regarding the frames identified in the public sphere, the media offered different interpretations, somewhat varying from the political leaders' intentions and from the citizens' perceptions. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Extraordinary Rendition:On Politics, Music, and Circular MeaningsRandall Everett AllsupThe purpose of this symposium is to look at music, education, and politics. I will begin with an examination of how musical meanings are politically rendered, and how these understandings are attached to moral consequences. Highly resistant to classification, musical meanings are those things we come to understand about ourselves through music, as opposed to musical knowledge which is demonstrable know-how. (...) While marching bands and flute sonatas can be judged with scores estimated to the 100th decimal point, the meanings that are created between the standards of practice of a given genre and the worldview of the listener or performer are provisional at best. Seen in this light, even seemingly secure or knowable realms like Christian heavy metal or anti-war movies are in fact highly un-objective and unpredictable. (More on Christian rock and movies in a moment). The challenge this paper seeks to uncover is participation on the hither side of fact, where understandings are rendered in a world that is contingent, political, and always in motion. What better example of the unclassifiable than the moving axes of politics and art?So what occurs between art and human or so-called "world" experience? [End Page 144] Let's agree that there is always motion, non-neutral, political movement in this interaction. We need not be students of French post-structuralism to recognize that we are part of many ever-evolving human-made systems, some of control, regulation, reward, punishment, and pleasure, but each with their own gravitation pull.1 I like Susan Sontag's take the best when she wrote that every place, every history has its own "sensibility," its own ineffable way of being in the world.2 Sensibilities—perhaps a clearer way of referring to politics in the context of art and experience—do not exist apart from their environment, yet they are more elusive than an idea or recognizable behavior.3 The sensibility of a time and place makes possible multiple discourses through which we make meaning.4 Some discourses, Foucault would remind us, are intensified by a history's particular sensibility and so appear louder than others. Such a discourse might speak so loudly that it shapes the meanings we make, drowning out options, and thus appearing obvious or commonsensical. The logic of musical assessment and evaluation—scoring marching bands and flute sonatas to the 100th decimal—is one such example.In spite of authoritative voices and reasonable discourses, each history's sensibility has its own escape routes, its own distortions and contradictions. I am fascinated by how we comply with or resist these pulls, as they are matters of agency and identity, matters of equity and social justice. In the present-day context of neo-liberalism and conservative values, especially 21st Century American fundamentalism, we would do well to ask how—not whether—such a fundamentalist sensibility shapes our ways of doing and knowing.5 My attempt is to locate music education in such a project.Shortly after the invasion of Iraq, I wrote a short piece on the fundamentalist imagination and its pull on the arts and education.6 This research took place at the 2003 MENC biennial where Bennett Reimer asks philosophy SRIG participants to consider (among other things) the role of metaphor in music education.7 I viewed the fundamentalist imagination as antithetical to metaphor: to paraphrase, the fundamentalist philosophy of education was "a philosophy for, not with, its initiates. Judgments are passed, not reached; answers are given, not argued... [Most importantly,] it is an educational method that emphasizes and then measures what is literal."8Since then, the voices of American literalism have appeared in increasingly loud volume seeking to discourage interpretation and argument in favor of handed-down teachings and binary logic. Supreme Court Justice Antonin Scalia decries the folly of a "living" constitution, in favor of a strict or literal reading. Retired Cardinal Bernard Law of Boston, in response to a common ground initiative by the late Joseph Bernadin, labels an appeal to "dialogue" a "fundamental flaw."9 Law sniffed, "Dissent from revealed truth or the authoritative [End Page 145] teaching of the church cannot... (shrink)

The work of the French literary review, intellectual grouping and publishing team Tel Quel had a profound impact on the formation of literary and cultural debate in the 1960s and 70s. Its legacy has had enormous influence on the parameters of such debate today. From its beginning in 1960 to its closure in 1982, it published some of the earliest work of Jacques Derrida, Julia Kristeva, Michel Foucault and Roland Barthes. It was also associated with some of the key (...) ideas of the French avant-garde, publishing key articles by Georges Bataille and Antonin Artaud. The Tel Quel Reader presents for the first time in English the key essays written by the Tel Quel group. Essays by Julia Kristeva, one of the review's editor's Michel Foucault, and a fascinating interview with Roland Barthes are here made available for the first time in English. It provides a unique insight into the post-structuralist movement and presents some of the pioneering essays on literature and culture, film, semiotics and psychoanalysis. Assembling key essays from over a twenty-year period, The Tel Quel Reader is an indispensible resource for students of literature, cultural and visual studies, philosophy and French studies. (shrink)

Abstract: There is no such thing as ‘the’ hylemorphic account of personal identity. There are several views that count as hylemorphic, and these views can be grouped into two main families—the corruptionist view, and the survivalist view. The differentiating factor is that the corruptionist view holds that the persistence of the soul is not sufficient for the persistence of the person, while the survivalist view holds that the persistence of the soul is sufficient for the persistence of the person. In (...) this paper, I argue that hylemorphists should prefer the corruptionist view. This project ought to be of interest to anyone working on issues of personal identity, not only because hylemorphic views are historically important, but also because they are currently receiving significant attention in the personal identity literature. (shrink)

Is childhood valuable? And is childhood as, less, or more, valuable than adulthood? In this article I first delineate several different questions that we might be asking when we think about the ‘value of childhood’, and I explore some difficulties of doing so. I then focus on the question of whether childhood is good for the person who experiences it. I argue for two key claims. First, if childhood wellbeing is measured by the same standards as adulthood, then children are (...) worse off than adults. Second, if childhood and adulthood wellbeing are measured by different standards, then we cannot compare them, and children are neither better off nor worse off than adults. This has some counter-intuitive implications, such as that we do not harm persons by depriving them of a childhood, nor by keeping them as children for elongated periods. (shrink)

Offers a vision of wholeness for approaching human ethical responses to what science is telling us about the crises facing our environment and climate.

An emerging discourse about automated agricultural machinery imagines farms as places where farmers and workers do not need to be, but also implicitly frames farms as intolerable places where people do not want to be. Only autonomous machines, this story goes, can relieve farmers and workers of this presumed burden by letting them ‘farm at a distance’. In return for this distanced autonomy, farmers are promised increased control over their work-life balance and greater farm productivity from letting ‘smart’ robots assume (...) control over the operational environment. Drawing upon the ways that these machines are promoted by manufacturers in various media, we trace the nascent contours of what we term a liberatory sociotechnical imaginary for agricultural automation across three cases—automated milking systems, self-driving tractors, and robotic strawberry pickers. We show how promises for new freedoms and autonomy are flexibly deployed to respond to distinct frictions that farmers, workers, and even farm animals experience in different modes of industrial agriculture. However, underlying these promises is the purposefully understated self-interest of manufacturers, who stand to gain further control over farms if automated technologies assume a central role in agriculture. Through the liberatory rhetoric, we contend, the imaginary seeks to enroll farmers into a socio-technical network that creates new relations of dependence upon the companies who design, sell, maintain, and often retain ownership over automated technologies. While potentially powerful, this imaginary may nonetheless fail to coalesce as farmers, workers, and agroecosystems exert their own agency on automated imaginaries and technological futures for agriculture. (shrink)

Stokes’ earlier chapter in this volume argued that, given the role ethical considerations play in our judgments of what to believe, ethical factors will put limits on the extent to which we can embrace particularism about conspiracy theories. However, that will only be the case if there are ethical problems with conspiracy theory as a practice (rather than simply as a formal class of explanation). Utilising the Lakatosian framework for analysing conspiracy theories developed by Steve Clarke, this paper identifies a (...) morally costly feature of conspiracy theorizing: its tendency to generate and expand new accusations purely to defend the core theory from countervailing evidence. Such 'auxiliary accusations' violate important norms around justified accusation, which supplies a defeasible, but important, reason to be reluctant to take part in the practice of conspiracy theorizing. (shrink)

Human propensities that are the products of Darwinian evolution may combine to generate a form of social behavior that is not itself a direct result of such pressure. This possibility may provide a satisfying explanation for the origin of socially transmitted rules such as the incest taboo. Similarly, the regulatory processes of development that generated adaptations to the environment in the circumstances in which they evolved can produce surprising and sometimes maladaptive consequences for the individual in modern conditions. These combinatorial (...) aspects of social and developmental dynamics leave a subtle but not wholly uninteresting role for evolutionary biology in explaining the origins of human morality. (shrink)

The language of “participant-driven research,” “crowdsourcing” and “citizen science” is increasingly being used to encourage the public to become involved in research ventures as both subjects and scientists....

Most philosophers who have expressed a view about whether forgiveness is compatible with forgivers’ continuing to punish, or support the punishment of, people who have wronged them hold that forgiveness is compatible with punishing or favouring punishment of wrongdoers. I argue that whether forgiveness entails forbearing punishment depends on which of two senses of forgiveness is operative. On the first, sentiment-based sense of forgiveness as consisting essentially in a change of heart on the part of a victim, a victim can, (...) I submit, forgive while continuing to punish or to support the punishment of a person who has wronged her. On the second sense of forgiveness as consisting in debt remission whether or not accompanied by a change of heart, the state’s remission of the entirety of criminal offenders’ punishment qualifies as forgiveness and, moreover, the state could not forgive offenders in this sense while continuing to punish them. (shrink)

The concept of media accountability is widely used but remains inadequately defined in the literature and often is restricted to a 1-dimensional interpretation. This study explores perceptions of accountability as manifestations of claims to responsibility, based on philosophical conceptions of the 2 terms, and suggests media accountability be more broadly understood as a dynamic of interaction between a given medium and the value sets of individuals or groups receiving media messages. The shape-shifting nature of the concept contributes to the volatility (...) of debate surrounding conflicting notions of press freedom and responsibility. (shrink)

Questions about dirty hands have often focused on legitimate, secure leaders deciding whether to violate important deontological principles or the rules of interpersonal morality. The purpose of this paper is to show that revolutionaries have dirty hands; revolutionaries do wrong by engaging in unilateral usurpation of the existing system with the hope that latter benefits will justify their actions. Yet, once the revolution securely generates improvements for the common good, the initial usurpation becomes increasingly irrelevant to judgments of the new (...) government’s legitimacy. The paper argues that only retroactive justification—where later success forces opponents and advocates to reinterpret the wrongness of the initial action—can fully capture the complex moral dynamics of revolutions. (shrink)

Modal logics have in the past been used as a unifying framework for the minimality semantics used in defeasible inference, conditional logic, and belief revision. The main aim of the present paper is to add adaptive logics, a general framework for a wide range of defeasible reasoning forms developed by Diderik Batens and his co-workers, to the growing list of formalisms that can be studied with the tools and methods of contemporary modal logic. By characterising the class of abnormality models, (...) this aim is achieved at the level of the model-theory. By proposing formulae that express the consequence relation of adaptive logic in the object-language, the same aim is also partially achieved at the syntactical level. (shrink)

As an approach to public engagement, deliberation has the potential to pursue a range of goals identified by public participation theorists including the opportunity to substantively inform policy processes, increase the public’s knowledge and understanding of public issues and create or restore loss of public trust and confidence in public institutions. Baum and colleagues (2009) offer several important take-home messages for policy makers and public health leaders about the value of engaging with the public about ethically challenging, value-laden and resource (...) intensive policy issues such as pandemic response planning. (shrink)

Gaia in Turmoil is the latest collaborative work put forth by the interdisciplinary group of Gaian thinkers. The contributors set out to meaningfully grapple with the bewildering ecological and social crises that humanity faces in this young century. Their work clearly rests on the assumption that such crises not only exist, but are dire—a conviction that unifies the essays in Gaia in Turmoil. By demonstrating how Gaia theory can advance various research projects, Gaia in Turmoil is an alarmist plea to (...) integrate the Gaian perspective into mainstream thought as the next watershed paradigm through which humanity can survive and prosper. (shrink)

L’essentiel des œuvres de Patočka et du dernier Foucault peut se lire à la lumière de la figure de Faust. Celle-ci éclaire en effet, au fil de ses variantes, ce qui oppose savoir de spiritualité et savoir de connaissance. Si l’on entend par spiritualité l’effort pour penser ensemble l’acte de connaissance et une transformation dans l’être du sujet, la légende faustienne illustre autant qu’elle questionne la pratique qui établit l’individu comme un être à même de se soucier de soi. Nous (...) préciserons cette idée à partir d’un exemple, celui de l’idéalisme allemand, en nous demandant s’il a su prendre la mesure de cette dimension faustienne de la philosophie et chercherons à savoir si c’est effectivement « le souci du souci de soi » qui l’a mis en mouvement ou l’a conduit à rechercher les conditions d’une spiritualité moderne. Nous nous demanderons, pour le dire dans des termes plus proches de ceux de Patočka, si l’on peut déjà apercevoir dans le postkantisme quelque chose qui anticipe l’idée d’une vue intellectuelle rendue possible par le phénomène. (shrink)

A significant criticism of the anthropic principle as a scientific claim is that testable predictions cannot be derived from it. Brandon Carter has argued, however, that the principle can be used to predict on the one hand that the period of time biological evolution is intrinsically likely to require is very large, and on the other that the number of ‘critical steps’ that have occurred in the evolution of life on earth is related to the length of time life can (...) continue to evolve. I attempt to show that neither of Carter's arguments provides a convincing defence of the testability of the anthropic principle. (shrink)

Cognitive states as well as cognitive commodities play central though distinct roles in our epistemological theories. By being attentive to how a difference in their roles affects our way of referring to them, we can undoubtedly accrue our understanding of the structure and functioning of our main epistemological theories. In this paper we propose an analysis of the dichotomy between states and commodities in terms of the method of abstraction, and more specifically by means of infomorphisms between different ways to (...) classify states of information, information-bases, and evidential situations. (shrink)

Berichte zur Wissenschaftsgeschichte, EarlyView.

In this paper incomplete data sets, or data sets with missing attribute values, have three interpretations, lost values, attribute-concept values and ‘do not care’ conditions. Additionally, the process of data mining is based on two types of probabilistic approximations, global and saturated. We present results of experiments on mining incomplete data sets using six approaches, combining three interpretations of missing attribute values with two types of probabilistic approximations. We compare our six approaches, using the error rate computed as a result (...) of ten-fold cross validation as a criterion of quality. We show that for some data sets the error rate is significantly smaller (5% level of significance) for lost values, for some data sets the smaller error rate is associated with attribute-concept values, and sometimes with ‘do not care’ conditions. Again, for some approaches the error rate is significantly smaller for saturated probabilistic approximations than for global probabilistic approximations, while for some approaches it is the other way around. Thus, for an incomplete data set, the best approach to data mining should be chosen by trying all six approaches. (shrink)