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)

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)

The human voice does not deceive. The one who is speaking is inevitably revealed by the singular sound of her voice, no matter “what” she says. We take this fact for granted—for example, every time someone asks, over the telephone, “Who is speaking?” and receives as a reply the familiar utterance, “It’s me.” Starting from the given uniqueness of every voice, Cavarero rereads the history of philosophy through its peculiar evasion of this embodied uniqueness. She shows how this history—along with (...) the fields it comprehends, such as linguistics, musicology, political theory, and studies in orality—might be grasped as the “devocalization of Logos,” as the invariable privileging of semantike over phone, mind over body. Female figures—from the Sirens to the Muses, from Echo to opera singers—provide a crucial counterhistory, one in which the embodied voice triumphs over the immaterial semantic. Reconstructing this counterhistory, Cavarero proposes a “politics of the voice” wherein the ancient bond between Logos and politics is reconfigured, and wherein what matters is not the communicative content of a given discourse, but rather who is speaking. (shrink)

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

The behavioral sciences have come under attack for writings and speech that affront sensitivities. At such times, academic freedom and tenure are invoked to forestall efforts to censure and terminate jobs. We review the history and controversy surrounding academic freedom and tenure, and explore their meaning across different fields, at different institutions, and at different ranks. In a multifactoral experimental survey, 1,004 randomly selected faculty members from top-ranked institutions were asked how colleagues would typically respond when confronted with dilemmas concerning (...) teaching, research, and wrong-doing. Full professors were perceived as being more likely to insist on having the academic freedom to teach unpopular courses, research controversial topics, and whistle-blow wrong-doing than were lower-ranked professors (even associate professors with tenure). Everyone thought that others were more likely to exercise academic freedom than they themselves were, and that promotion to full professor was a better predictor of who would exercise academic freedom than was the awarding of tenure. Few differences emerged related either to gender or type of institution, and behavioral scientists' beliefs were similar to scholars from other fields. In addition, no support was found for glib celebrations of tenure's sanctification of broadly defined academic freedoms. These findings challenge the assumption that tenure can be justified on the basis of fostering academic freedom, suggesting the need for a re-examination of the philosophical foundation and practical implications of tenure in today's academy. (Published Online February 8 2007) Key Words: academia; academic freedom; ethical issues; faculty beliefs; professoriate; promotion; scientific misconduct; tenure; whistle-blowing. (shrink)

The article approaches the attempts at theoretical reduction of the mental and the social and mantains that the reductionist projects are based on ontological and epistemological presuppositions that relate to an atomist vision of the world that grounds untenable humean conceptions of causality a..

This pathbreaking work pursues two interwoven themes. Firstly, it engages in a deconstruction of Ancient philosopher's texts--mainly from Plato, but also from Homer and Parmenides--in order to free four Greek female figures from the patriarchal discourse which for centuries had imprisoned them in a particular role. Secondly, it attempts to construct a symbolic female order, reinterpreting these figures from a new perspective. Building on the theory of sexual difference, Cavarero shows that death is the central category on which the whole (...) edifice of traditional philosophy is based. By contrast, the category of birth provides the thread with which new concepts of feminist criticism can be woven together to establish a fresh way of thinking. Cavarero develops a philosophical narrative which, by re-interpreting each of the four figures of ancient thought, uncovers several images of the female desire for self-representation. Plato himself had not forseen that one day female subjectivity would assert its autonomy, plundering and throwing into confusion the patriarchal text in order to tell another story. (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 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.

Las sucesivas formas en que en la Argentina se encaró la modernización desde la época de la organización nacional hasta nuestros días, muestran un marcado desinterés por los problemas de la integración. Antes bien, tanto las políticas sociales y culturales internas, como las políticas económicas que fijaron la posición de la Argentina en el mercado mundial, favorecieron la desintegración y la exclusión de importantes sectores de la población, en lo interno; y en lo externo fomentaron la rivalidad con los países (...) limítrofes y la tendencia a la desvinculación con otros países de América Latina. Todo ello dificultó la puesta en práctica de proyectos de integración latinoamericana y la formación de bloques económicos regionales. Las políticas educativas estuvieron a tono con esta orientación general, fomentando a través del curriculum y de los rituales instalados en las prácticas educativas cierta comprensión de lo nacional presentada como excluyente de otras posiciones abiertas a la integración. En esa línea lo nacional se opone a lo regional, lo “propio” constituye una barrera para visualizar lo “común”. (shrink)

The paper discusses the problem of naturalistic theories of mind-body relation. It displays knotting lines of arguments, which are presented by two influential philosophers: O. Flanagan and C. McGinn. The former author claims that the mind-body problem can easy be resolved by showing that mind and body are two somehow similar concepts. The latter is strongly convinced that because of human epistemic limitations we cant in principle to formulate solution of psychophysical problem. I go on to argue that we can (...) prepare good empirical hypotheses but I see no way to answer the philosophical question: how it is possible that subjective phenomenal states like pain, tickle etc. "are made" from physical staff? (shrink)

A retrospective ELSPAC study (N = 2756) compared three groups of mothers of three-year-old children: 1) employed, 2) voluntarily unemployed, and 3) involuntarily unemployed, about the quality of their partnership and family relationships. The results show that the involuntarily unemployed mothers have the lowest quality of family life. In these families there is more conflict, disagreement and hostile communication towards the woman and child. Employed mothers also experience some family problems. Overall, those most satisfied with their family lives are the (...) voluntarily unemployed mothers. There is more positive communication between partners, including sharing and intimacy in this group. The results were interpreted as stemming from the distress caused by involuntary unemployment, the double burden of the female role and gender role models in the family. (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)

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)

The paper contrasts understandings of knowledge grounded in Enlightenment norms with the departures from those norms taken by some strands of feminism and hermeneutics, as well as the contributions made by the writing of Michel Foucault. A reading of Foucault's writings on knowledge, power and the discursive constitution of self and world is offered as a potentially useful frame within which to raise questions about nursing, nurses and knowledge.

W 1957 r. powstało Towarzystwo Rozwoju Ziem Zachodnich (TRZZ), którego celem było przybliżanie informacji na temat ziem leżących na wschód od Odry i Nysy Łużyckiej, które przyłączono do Polski po II wojnie światowej. Towarzystwo od 1959 r. posiadało swoją filię w Wyższej Szkole Pedagogicznej, a od 1967 r. także w Wyższej Szkole Inżynierskiej w Opolu. Skupieni w nich studenci uczestniczyli m.in. w wykładach i konferencjach poświęconych kwestii przed- i powojennych związków ziem zachodnich z polskością oraz problemowi dążeń RFN i ich (...) sojuszników do przywrócenia tych terenów zwierzchności niemieckiej. Studenci organizowali także wyjazdy i imprezy rozrywkowe. Działalność obu kół studenckich wygasła w 1970 r., po tym jak rozwiązano TRZZ. (shrink)

Compartimos avances de investigación sobre las concepciones de los docentes universitarios respecto a la formación integral y la cultura de paz, pues ello incide en los procesos formativos. A partir de su discurso identificamos que el desarrollo de capacidades emocionales es fundamental para aprender a resolver conflictos y construir nuevas formas de convivencia a favor de la cultura de paz.

La memoria es el principio de la justicia que permite destruir el vínculo entre el poder y la violencia que funda y mantiene el orden del derecho. La justicia de la memoria es, en efecto, una fuerza revolucionaria que anuncia el sufrimiento de los oprimidos, de los vencidos, de los sojuzgados de la historia; es una especie de antihistoria que se rebela ante el poder que somete la vida natural a un estado de excepción permanente; es una justa apelación a (...) la justicia más allá del derecho que permite instaurar un nuevo orden fundado en la vida como potencia y como vida justa. (shrink)

Moral and political theories, insofar as they are based on the fragile life of human beings, usually incorporate a reflection on the role of uncertainty or contingency. The question remains however, how exactly do we experience ‘uncertainty’? Can it show us different faces, to which we then react in different ways? If so, what is the meaning of such multiplicity for the exercise of agency? Comparing Bergson’s inquiry into the modern belief in chance with Jean-Marie Guyau’s reflections on the love (...) of risk, I examine the moral significance of different ways of relating to uncertainty, and analyze their respective pedagogical purchase regarding the constitution of human freedom. When confronted with the unknown future, human agency gets easily trapped in the vicious and vertiginous circle of impotence and omnipotence. The contrast between Bergson and Guyau illuminates this problem, showing how our relation to uncertainty informs our identity, our capacity for action, and our sense of obligation. (shrink)

Uno de los ejes que atraviesa la obra de Arturo Andrés Roig es la cuestión del sujeto. La filosofía, dice, "se trata de una meditación en la que no sólo interesa el conocimiento, sino también el sujeto que conoce … en su realidad humana e histórica" (Roig, 1981, 9). Justamente por su referencia a esa realidad humana e histórica, el filosofar no es ajeno al modo de habitar el hombre en el mundo. En otras palabras, el universo del discurso filosófico (...) hace referencia a un universo de lo real histórico. En esa tensión se juega la praxis filosófica, que si ha de ser liberadora, requiere la tematización tanto de la "subjetividad" como de la "morada". Al hilo de estas cuestiones trazamos un itinerario filosófico de Arturo Andrés Roig que lleva el propósito de servir de introducción al presente Dossier de la Revista Estudios de Filosofía Práctica e Historia de las Ideas, el cual se realiza como homenaje y afectuoso recuerdo de quien fuera su director. One axis that runs through the work of Arturo Andrés Roig is the question of the subject. Philosophy, he says, "is a matter of a meditation in which it is concerned not only the knowledge, but also the subject that knows… in his human and historical reality" (Roig, 1981, 9). Precisely because of this reference to human and historical reality, philosophizing is not strange to the man´s way of living in the world. In other words, the universe of the philosophical discourse In other words, the universe of the philosophical discourse refers to a universe of historical reality. It is in this tension where the philosophical praxis is played, which if it must be liberating, requires to question about both, "subjectivity" and "residing". In line with these issues we draw up a philosophical itinerary of Arturo Andrés Roig which has the purpose of serving as the introduction to the present Dossier of the Estudios de Filosofía Práctica e Historia de las Ideas academic journal, which is held in honor and loving memory of its former Director. (shrink)

La crisi di identità non riguarda solo i soggetti politici, ma il concetto stesso di democrazia. Con l’avvento della società della comunicazione i parametri politici con cui pensavamo le forme del potere, l’azione e l’organizzazione politica, sono definitivamente cambiati. Siamo nel pieno della quarta mutazione della storia dell’umanità. Percepiamo la crisi laddove c’è transizione. Bisogna ricostruire le categorie cognitive e interpretative dei fenomeni esistenti. La democrazia è minacciata, non più e non solo da un nuovo regime, ma da se stessa (...) e dalle spinte verso un network politico autocratico. Per ritornare a vivere in network autenticamente democratici bisogna costruire nuovi vocabolari che permettano di re-interpretare il mondo con nuove narrazioni politiche. (shrink)

La entrevista tiene por objetivo problematizar los vínculos del cine y la educación en la escuela, afirmando y defendiéndola en su precariedad, como una alternativa contundente de espacio-tiempo de concentración y atención al mundo y como pausa voluntaria de la hiperconectividad que nos hace perder el sueño y las posibilidades de soñar otro mundo, como gesto de alteración e invención.

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)

O espelho da arte clássica se multiplicou em fragmentos e influenciou a arquitetura grega e seus desdobramentos, verificados no decorrer do que rotulamos chamar de história da arte. A arquitetura e o urbanismo praticados pelos gregos, e mais tarde pelos romanos, foi elemento de inspiração para personalidades de liderança e artistas nos grandes períodos históricos da humanidade, onde a cidade era tida como elemento principal da vida política e social dos povos. Do clássico ao neoclássico, o desdobramento inspirado na estética (...) da antiguidade chega ao Brasil através da corte portuguesa e se fortalece com a missão artística francesa, tornando-se uma característica estilística no Brasil do século XIX. Unir, portanto, esses fragmentos estilísticos em busca do verdadeiro reflexo clássico é o objetivo deste artigo. (shrink)

Justiça, lei e poder são três conceitos que se interligam na História da Guerra do Peloponeso, de Tucídides. Este artigo desenvolve-se em torno do confronto que se pode estabelecer entre as noções de nomos (lei) e physis (natureza), tanto em Tucídides, como nos sofistas, nos pré-socráticos, em Platão e Aristóteles.

The aim of the analyzes carried out in this paper is to show that within the multitude of theories of perception which center their main presuppositions around the idea of action and embodiment, we can distinguish a body of approaches, which characteristically emphasize the following claims: that it is the living organism that should serve as perceiving subject; that perceptual states are not only a form of action but primarily a form of consciousness; that perceptual information is obtained by perceiving (...) subjects from the environment by means of so-called perceptual invariants. (shrink)