BackgroundWe describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512). This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions were (...) evaluated. Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model analysis were used to determine factors potentially influencing the timelines. The Cluster Analysis procedure was used to identify homogenous groups of cases.ResultThe authorisation process was completed in 7.7 to 53.8 months in European countries and in 17.1 to 27.1 months in non-European countries. The main factors influencing these timelines were the requests for changes/clarifications in European countries and the different national legislations in non-European countries.ConclusionThis work confirms that the procedures and requirements for the clinical trial application of a paediatric trial are different. In the European Union, the timeframes for submission were generally harmonised but longer. In non-European countries, delays were caused by national dispositions but the entire authorisation process resulted faster with less requests from ECs/cas. The upcoming application of Regulation (EU) 536/2014 is expected to harmonise practices in Europe and possibly outside. Networks on paediatric research acting at international level will be crucial in this effort. (shrink)

The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the different steps including (...) the registration of the trial in the European database; the preparation of documents to be submitted and their contents; the preparation of documents related to the information and consent process; the submission to competent bodies. Specific issues related to paediatric research and trials involving non EU/EEA countries have been addressed as well. Results reveal that the European legislation offers a well defined set of European rules covering different aspects of a Clinical Trial Application. However, these are not suitable to meet the challenges from multicentre and multinational clinical studies. A stronger set of rules, such as is available in a composite European Regulation has been adopted and is expected to harmonise practices and enable sponsors to carry out well conducted trials. But will the new regulation overcome the existing criticisms of Directive 2001/20/EC? (shrink)

In his unpublished 1979 Lectures on the Philosophy of Mind, Saul Kripke offers a knowledge argument against materialism focusing on deaf people who lack knowledge of auditory experience. Kripke's argument is a precursor of Frank Jackson's better‐known knowledge argument against materialism (1982). The paper sets out Kripke's argument, brings out its interest and philosophical importance, and explores some similarities and differences between Kripke's knowledge argument and Jackson's.

What does a truly democratic experience of political action look like today? In this provocative new work, Adriana Cavarero weighs in on contemporary debates about the relationship between democracy, happiness, and dissent. Drawing upon Arendt's understanding of politics as a participatory experience, but also discussing texts by Émile Zola, Elias Canetti, Boris Pasternak, and Roland Barthes, along with engaging Judith Butler, Cavarero proposes a new view of democracy, based not on violence, but rather on the spontaneous experience of a (...) plurality of bodies coming together in public. Expanding upon the themes explored in previous works, Cavarero offers a timely intervention into current thinking about the nature of democracy, suggesting that its emergence thrives on the nonviolent creativity of a widespread, participatory, and relational power that is shared horizontally rather than vertically. From digital democracy to selfies to contemporary protest movements, Cavarero argues that we need to rethink our focus on individual happiness and turn toward rediscovering the joyful emotions of birth through plural interaction. Yes, let us be happy, she urges, but let us do so publicly, politically, together. (shrink)

In this chapter we will try to show how the introduction of Darwinian evolutionary theory transformed metaphysics, and in particular, the philosophical understanding of the temporality of being. In the interests of brevity, we will focus on two particularly significant aspects of the impact of Darwinism on Latin America. We will consider, first, how the new evolutionary thought transformed past notions of temporality. Second, we will discuss the ways in which the ideas of regression and extinction, viewed as essential components (...) of the evolutionary process, problematized the nature of progress and civilization. We trace these developments in the work of three central figures of Latin American thought: José Martí, José Rodó, and Euclides da Cunha. All three of these men were extraordinarily versatile thinkers, and each has been the subject of voluminous secondary literature. But the first two, unlike some other influential figures—such as, famously, Domingo Sarmiento of Argentina—were hardly self-professed Darwinians. Still, we have chosen to discuss them because of this last fact, and not despite it. As for da Cunha, though he accepted the basic canons of the new evolutionary theory, he remained ambivalent about its application. All three struggled, each in his own way, to come to terms with the Darwinian legacy, and each found his thinking profoundly shaped by this struggle; they offer us three different, unique perspectives on the impact of Darwinism. The magnitude of the new evolutionism can only be understood if we consider the wide range of discussion it triggered in consequence of its profound philosophical impact. (shrink)

A growing interest in and concern about the adequacy and fairness of modern peer-review practices in publication and funding are apparent across a wide range of scientific disciplines. Although questions about reliability, accountability, reviewer bias, and competence have been raised, there has been very little direct research on these variables.The present investigation was an attempt to study the peer-review process directly, in the natural setting of actual journal referee evaluations of submitted manuscripts. As test materials we selected 12 already published (...) research articles by investigators from prestigious and highly productive American psychology departments, one article from each of 12 highly regarded and widely read American psychology journals with high rejection rates (80%) and nonblind refereeing practices.With fictitious names and institutions substituted for the original ones (e.g., Tri-Valley Center for Human Potential), the altered manuscripts were formally resubmitted to the journals that had originally refereed and published them 18 to 32 months earlier. Of the sample of 38 editors and reviewers, only three (8%) detected the resubmissions. This result allowed nine of the 12 articles to continue through the review process to receive an actual evaluation: eight of the nine were rejected. Sixteen of the 18 referees (89%) recommended against publication and the editors concurred. The grounds for rejection were in many cases described as “serious methodological flaws.” A number of possible interpretations of these data are reviewed and evaluated. (shrink)

This essay answers two questions that continue to drive debate in moral and legal philosophy; namely, ‘Is a risk of harm a wrong?’ and ‘Is a risk of harm a harm?’. The essay’s central claim is that to risk harm can be both to wrong and to harm. This stands in contrast to the respective positions of Heidi Hurd and Stephen Perry, whose views represent prominent extremes in this debate about risks. The essay shows that there is at least one (...) category of risks – intentional impositions of risk on unconsenting agents – which can be both wrongful and harmful. The wrongfulness of these risks can be established when, on the balance of reasons, one ought not to impose them. The harmfulness of these risks can be established when the risks are shown to set back legitimate interests. In those cases where risks constitute a denial of the moral status of agents, risks set back agents’ interest in dignity. In these ways, the essay shows that there are instances when a risk can constitute both a wrong and a harm. (shrink)

One of the fundamental properties of human language is movement, where a constituent moves from one position in a sentence to another position. Syntactic theory has long been concerned with properties of movement, including locality restrictions. This work investigates how different movement operations interact with one another, focussing on the special case of smuggling. The contributions in this volume each describe different areas where smuggling derivations play a role, including passives, causatives, adverb placement, the dative alternation, the placement of measure (...) phrases, wh-in-situ and word order in ergative languages. Other issues addressed in the volume include the freezing constraint on movement and the acquisition of smuggling derivations by children. (shrink)

Theauthorproposesanewvariantofsemanticminimalismcombininganti-intentionalism(theviewaccordingtowhich thesemanticcontentofutteredsentencesisindependentofspeakerintentions)withtherejectionofpropositional ism(theviewaccordingtowhichthesemanticcontentofutteredsentencesalwaysreachesthelevelofaproposition,i .e.acontentpotentiallyfiguringastheobjectofanattitude).Investigatingthespecificsofdemonstrativeexpre ssionsasatouchstoneforherminimalistaccount,bydecouplingthenotionofatruth-conditionfromthatofaproposi tiontheauthormanagestostaywithintheboundsofatruth-conditionalaccount,whiletakingintoaccountthatthere ferentsofdemonstrativeexpressionscannotbedeterminedwithoutreferencetospeakerintentions.

This volume bridges contemporary philosophical conceptions of risk and responsibility and offers an extensive examination of the topic. It shows that risk and responsibility combine in ways that give rise to new philosophical questions and problems. Philosophical interest in the relationship between risk and responsibility continues to rise, due in no small part due to environmental crises, emerging technologies, legal developments, and new medical advances. Despite such interest, scholars are just now working out how to conceive of the links between (...) risk and responsibility, the implications that risks may have to conceptions of responsibility (and vice versa), as well as how such theorizing might play out in applied cases. With contributions from leading scholars, this volume brings together new work examining the interplay between risk and responsibility, exploring its varied philosophical aspects and applications to contemporary issues in law, bioethics, technology, and environmental ethics. Risk and Responsibility in Context will be of interest to philosophers working in ethics, bioethics, philosophy of law, and philosophy of technology, as well as scholars and practitioners in law, health and science management, public policy, and environmental studies. (shrink)

Barnett Newman : Adam's line -- Kant and the newborn -- Virginia Woolf and the shadow of the "I" -- Plato erectus sed -- Men and trees -- We are not monkeys : on erect posture -- Hobbes and the macroanthropos -- Elias Canetti : upright before the dead -- Artemisia : the allegory of inclination -- Leonardo and maternal inclination -- Hannah Arendt : "a child has been born unto us" -- Schemata for a postural ethics -- Coda : (...) adieu to Lévinas. (shrink)

This volume deals with collocations from a lexicographic perspective by addressing, in detail, the boundaries between collocations and other word combinations, the possibility of adapting the definition of collocation to the objectives of specific dictionaries, and approaches towards collocation extraction for lexicographic purposes.

While firms' engagement with Corporate Social Responsibility has been associated with positive performance impacts, little is known about the incorporation of the United Nations 2030 Agenda into business practices. Precisely, although the literature suggests that firms are pursuing the Sustainable Development Goals (SDGs), there are limited insights on their strategy to implement them in the context of developing countries. To address this gap, we conducted a comprehensive large-scale investigation of 2030 Agenda adoption by Brazilian companies. Accordingly, the analysis of our (...) multicase study reveals (1) variations on the business opportunities brought by the SDGs depending on the firm position in the value chain, (2) which SDGs and target stakeholders are addressed through corporate policies and practices, (3) the different ways firms embrace the SDGs to pursue ambidexterity. Our findings clarify how firms in the developing countries interpret the institutional pressures and assemble their internal resources to respond to the SDGs challenges. Boundary conditions and policy implications are further discussed. (shrink)

Toward a Feminist Ethics of Nonviolence brings together three major feminist thinkers to discuss Cavarero's call for a postural ethics of nonviolence. The book consists of three longer essays by Cavarero, Judith Butler, and Bonnie Honig, followed by shorter responses by a range of scholars that widen the dialogue, drawing on post-Marxism, Italian feminism, and queer theory. Together, the authors contest the boundaries of their common project for a pluralistic, heterogeneous, but urgently feminist ethics of nonviolence."--Back cover.

This paper presents a series of 4 single subject experiments aimed to investigate whether children with autism show more social engagement when interacting with the Nao robot, compared to a human partner in a motor imitation task. The Nao robot imitates gross arm movements of the child in real-time. Different behavioral criteria (i.e. eye gaze, gaze shifting, free initiations and prompted initiations of arm movements, and smile/laughter) were analyzed based on the video data of the interaction. The results are mixed (...) and suggest a high variability in reactions to the Nao robot. The results are as follows: For Child2 and Child3, the results indicate no effect of the Nao robot in any of the target variables. Child1 and Child4 showed more eye gaze and smile/laughter in the interaction with the Nao robot compared to the human partner and Child1 showed a higher frequency of motor initiations in the interaction with the Nao robot compared to the baselines, but not with respect to the human-interaction. The robot proved to be a better facilitator of shared attention only for Child1. Keywords: human-robot interaction; assistive robotics; autism. (shrink)

This paper analyses how the Cold War influenced the discourses on basic research and on Science and Technology Policies of some leaders of the Argentine research community. It explores two key intersections to study the Cold War: the first between politics and policies; the second between the global and the regional/national. The basic assumption is that, just as there was no one Cold War, specific regional and national traits lent specific meanings to basic research. In dialogue with the literature on (...) Latin American history of STPs, on Cold War and on the conceptual history of science, the paper identifies three discursive configurations around S&T: the first refers to the semi-peripheral scientific context; the second is associated with the ‘democracy-totalitarianism’ dichotomy, and the third is linked to the ‘development-dependence’ dichotomy. Finally, the paper also traces some connections between these discourses and the institutional models proposed by different key actors of the research community to implement STPs. (shrink)

This paper presents a series of 4 single subject experiments aimed to investigate whether children with autism show more social engagement when interacting with the Nao robot, compared to a human partner in a motor imitation task. The Nao robot imitates gross arm movements of the child in real-time. Different behavioral criteria were analyzed based on the video data of the interaction. The results are mixed and suggest a high variability in reactions to the Nao robot. The results are as (...) follows: For Child2 and Child3, the results indicate no effect of the Nao robot in any of the target variables. Child1 and Child4 showed more eye gaze and smile/laughter in the interaction with the Nao robot compared to the human partner and Child1 showed a higher frequency of motor initiations in the interaction with the Nao robot compared to the baselines, but not with respect to the human-interaction. The robot proved to be a better facilitator of shared attention only for Child1. Keywords: human-robot interaction; assistive robotics; autism. (shrink)

This essay focuses on anthropomorphism as both a form of hype and fallacy. As a form of hype, anthropomorphism is shown to exaggerate AI capabilities and performance by attributing human-like traits to systems that do not possess them. As a fallacy, anthropomorphism is shown to distort moral judgments about AI, such as those concerning its moral character and status, as well as judgments of responsibility and trust. By focusing on these two dimensions of anthropomorphism in AI, the essay highlights negative (...) ethical consequences of the phenomenon in this field. (shrink)

In this article, caring, remembering and sharing memory are presented as moral responses, the case study being Alzheimer’s disease (AD). Memory connects memories and images, while care connects individuals, which is an ethical issue. When a person’s memory is lost, the care of others becomes the only thread connecting them to the world. AD deprives a person of memories, body control, makes it impossible to remember, communicate, move, recognize the environment, and disrupts consciousness. Caring for a patient with a neurodegenerative (...) brain disease requires constant reminding and reiteration; the presence of a caring person reminds of what the patient themselves can no longer remember. Lost memories do not mean that life or relational values have also lost their meaning. The description of the memory movement emphasizes the importance of repetition in the moral act. Highlighting the matter of care, also in scientific work, is the aim of this text. To care is to remember, on behalf of the AD patient, about the patient’s life. Within bioethical research, moral responses are an important point for projects which seek to improve the condition of patients—not only the condition of health but also the comfort of life. This improvement will not be possible without attentive, committed caregivers and their responsible attitude in the face of the phenomenon of memory loss. (shrink)

Adriana Novoa and Alex Levine offer here a history and interpretation of the reception of Darwinism in Argentina, illuminating the ways culture shapes ...

Polyphony of Anxiety. The Interview with Stefano Micali about His Book Phenomenology of Anxiety.

This paper presents a series of 4 single subject experiments aimed to investigate whether children with autism show more social engagement when interacting with the Nao robot, compared to a human partner in a motor imitation task. The Nao robot imitates gross arm movements of the child in real-time. Different behavioral criteria were analyzed based on the video data of the interaction. The results are mixed and suggest a high variability in reactions to the Nao robot. The results are as (...) follows: For Child2 and Child3, the results indicate no effect of the Nao robot in any of the target variables. Child1 and Child4 showed more eye gaze and smile/laughter in the interaction with the Nao robot compared to the human partner and Child1 showed a higher frequency of motor initiations in the interaction with the Nao robot compared to the baselines, but not with respect to the human-interaction. The robot proved to be a better facilitator of shared attention only for Child1. Keywords: human-robot interaction; assistive robotics; autism. (shrink)

Relating Narratives is a major new work by the philosopher and feminist thinker Adriana Cavarero. First published in Italian to widespread acclaim, Relating Narratives is a fascinating and challenging new account of the relationship between selfhood and narration. Drawing a diverse array of thinkers from both the philosophical and the literary tradition, from Sophocles and Homer to Hannah Arendt, Karen Blixen, Walter Benjamin and Borges, Adriana Cadarero's theory of the `narratable self' shows how narrative models in philosophy and (...) literature can open new ways of thinking about formation of human identities. By showing how each human being has a unique story that can be told about them, Adriana Cavarero inaugurates an important shift in thinking about subjectivity and identity which relies not upon categorical or discursive norms, but rather seeks to account for `who' each one of us uniquely is. (shrink)

In 1942, American Nobel Prize-winning physicist Arthur Compton pointed out that, “Because in this field of cosmic ray studies certain unique advantages are given by their geographical position, this field of physics has been especially emphasized in South America.” This paper seeks to interrogate the making of Latin America's uniqueness with respect to cosmic-ray research through an analysis that considers Compton's geographical argument, but also goes beyond it, referring to the interactions of nature, knowledge, practices, scientific communities, and diplomacy. To (...) begin with, it highlights the place-based strategies and practices associated with cosmic-ray research. Once research in the field at different altitudes demonstrated that cosmic rays traveled from outer space to the Earth surface, their nature was scrutinized by expeditions that covered broad vertical and horizontal expanses. The study of cosmic rays in Latin America displayed the mobilization of that strategy, which reinforced the reliability of certain sites located at high altitudes and close to the geomagnetic equator in projected investigations. Moreover, such analysis of cosmic rays involved research practices in the field, the emergence of (local, regional, or international) research traditions, and the creation of spaces of knowledge at different scales. By centering on the interaction of knowledge and place, this paper shows that an exploration of the “up-and-down journeys” of cosmic-ray research in Latin America expands our understanding of the geographies and practices of 20th-century physics. (shrink)

La paz y la seguridad internacionales no sólo son el resultado de la ausencia de guerras, es decir, no son únicamente el fundamento de la preservación del orden o ausencia de violencia, sino que incluyen también, para ser alcanzadas, aspectos diversos, tales como la seguridad alimentaria. Dentro del abanico de los nuevos riesgos y amenazas a la paz y seguridad internacionales, cada vez más se está teniendo en consideración las repercusiones negativas que tienen las crisis alimentarias y el hambre que (...) sufren en torno a 800 millones de personas en todo el mundo. La preocupación y abordaje de estos temas hizo que por primera vez, el 30 de marzo de 2016, la FAO se dirigiese al Consejo de Seguridad con el objetivo de reafirmar la necesidad de mejorar la seguridad alimentaria como aspecto fundamental para la consolidación de una paz y seguridad internacional sostenibles. (shrink)

The main purpose of this paper is to make a reflection on the war from the work both by Karl von Clausewitz and Raymond Aron. The hypothesis proposed herein is that a misunderstanding of the theories proposed by the Prussian General may have led to an erroneous recognition about him as father of some tactics employed by some totalitarian regimes of the 20th Century in order to crush their opponents. In an effort to corroborate this idea, the analysis will be (...) based on two seminal sources, the Vom Kriege and Thinking about the war, Clausewitz, which will be supplemented by secondary literature comprising books and articles. It is to avoid that local and international conflicts that are unleashed on the world stage be approaching the limits of absolute war is to practice moderation (an essential political understanding) when making decisions related to the military leadership of the confrontation. (shrink)