BackgroundWe describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial. 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 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)

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

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)

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)

_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)

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.

In For More than One Voice, Adriana Cavarero argues that “voice” has primacy over other concepts characterizing human existence.1 She introduces this claim through an exegesis of Italo Calvino’s text “A King Listens”.2 The fictitious king, paranoid, insomniac, has reduced himself to a “great ear.” He no longer pays attention to the content of what his courtiers say to him. His ear picks up only the “vocal timbre of their voices.” This timbre is “artificial, false, ‘cold,’ like death.” But (...) it is sufficient for the king’s fanatical vigilance to distinguish between fawning fidelity and furtive betrayal. One day, however, the king’s auditory world is disturbed by the singing of a woman whose voice he hears... (shrink)

Excerpt: In 1995, the Leo Apostel Centre in Brussels, Belgium, organised an international conference called ``Einstein meets Magritte''. Nobel prize winner Ilya Prigogine held the opening lecture at the conference, and Heinz von Foerster's lecture was scheduled last... Heinz von Foerster was enchanted by the conference theme and -- in the spirit of surrealist Belgian painter René Magritte -- had chosen an appropriate title for his talk: ``Ceci n'est pas Albert Einstein''. ... [H]e was delighted to grant the organisers (...) the following interview, in which he tells us about an even longer journey -- that of his remarkable life and scientific career. (shrink)

The aim of this paper is to focus specifically on the description of the homo politicus as a sovereign individual who governs itself. Searching to understanding of neoliberalism as a governing rationality through which everything becomes economized.

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)

This short contribution is written on the occasion of the book discussion of Sophie Loidolt’s Phenomenology of Plurality: Hannah Arendt on Political Intersubjectivity at the Institute for Philosophy and Social Theory. It presents an attempt to read the two key notions Loidolt elaborates in her book – spaces of meaning and spaces of the public and private – from a critical perspective offered by Judith Butler’s taking up of Arendt’s work. Offering Butler’s conception of social ontology through several major points (...) of contestation with Arendt, I argue against an all too simple reduction of her understanding of the political and normativity to poststructuralist ones. (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 (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)

It appears at least intuitively appropriate to claim that we owe it to victims to punish those who have wronged them. It also seems plausible to state that we owe it to society to punish those who have violated its norms. However, do we also owe punishment to perpetrators themselves? In other words, do those who commit crimes have a moral right to be punished? This work examines the sustainability of the right to be punished from the standpoint of the (...) two main theories of rights—the will and the interest conceptions. The right to be punished is shown to be largely indefensible on both accounts: on the will theory, the right to be punished conflicts with autonomy, and it can neither be claimed nor waived by a perpetrator; on the interest theory, a perpetrator’s interest in punishment, inasmuch as it exists, is not sufficient to ground a duty on the part of the state. (shrink)

In this brilliant book, one of the world's most provocative feminist theorists and political philosophers introduces a new word? horrorism?to capture the experience of violence.

This volume assesses Friedrich Schleiermacher s contribution to the theory and practice of translation two hundred years after his classic text "On the Different Methods of Translating". It brings together scholars from Philosophy and Translation Studies who offer close readings of Schleiermacher s ideas, placing them in the context of his hermeneutics and examining their relevance today as well as their potential to inspire further work.".

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 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)

Adriana Ayers studies the evolution of kotex advertising, focusing specifically on the way in which African American women were figured into changing advertisers’ conceptions of womanhood. The article analyzes images featured in various women’s magazines to examine how ideas surrounding menstruation were packaged and sold to women.

Several contemporary philosophical theories of introspection have been offered, yet each faces a number of difficulties in providing an explanation of the exact nature of introspection. I contrast the inner-sense view that argues for a causal awareness with the acquaintance view that argues for a non-causal or direct awareness. After critically examining the inner-sense and the acquaintance views, I claim that these two views are complementary and not mutually exclusive, and that both perspectives, conceived of as modes of introspective access, (...) actually broaden the notion of introspection. I then propose a useful distinction between stimuli-induced introspection—i.e., a receptive process whereby some specific mental states induce introspection—and self-triggered introspection—i.e., a selective process whereby the individual’s own interest and volition initiates introspection. I argue that that distinction may eliminate the false dichotomy which claims that only one of those types of awareness, either the causal one or the direct one, is conducive to introspection or is defined as introspection. (shrink)

Resumo: Palavras-chave: : Keywords : Reading. Jornadinha Nacional de Literatura. Reception. Experience.Representation. This article makes an analysis on the role of Jornadinhas Nacionais de Literatura de Passo Fundo, with emphasis on representations of its 4th edition, built by children of 10 years, from the middle class of RS – Ijuí, students of a private school in same municipality. Testimonies of these children are examined at four different times in the light of the Aesthetics of Reception and the Sociology of Reading. (...) The four stages are called placements, a methodology created by Judith Langer and used in this analysis. Thus, this discussion seeks to understand how to make the experience of reading and living of the children mentioned in that moment, in the process of building the 4ª Jornadinha Nacional de Literatura, they intersect and provide representation for the target audience of this work. Leitura. Jornadinha Nacional de Literatura. Recepção. Experiência. Representação. Este artigo faz uma análise do papel das Jornadinhas Nacionais de Literatura de Passo Fundo, com ênfase nas representações da sua 4ª edição, construídas por crianças de 10 anos de idade, provenientes da classe média de Ijuí – RS, estudantes de uma escola particular no mesmo município. São examinados depoimentos dessas crianças em quatro momentos diferentes, à luz da Estética da Recepção e da Sociologia da Leitura. Os quatro momentos são chamados posicionamentos , uma metodologia criada por Judith Langer e utilizada nesta análise. Assim, esta reflexão busca compreender como se dão as experiências de leitura e de vida das crianças mencionadas e em que momento, no processo de construção da 4ª Jornadinha Nacional de Literatura, elas se cruzam e propiciam representações para o público-alvo deste trabalho. (shrink)

This article discusses three major dilemmas embedded in women's labor migration by focusing on undocumented Latina migrants in Israel. The first is that to break the cycle of blocked mobility in their homelands, migrant women must take jobs that they would have never taken in their countries of origin, despite uncertainty about possible economic outcomes. The second dilemma is that the search for economic betterment leads Latina migrants to risk living and working illegally in the host country, forcing them to (...) remain on the margins of society. The third dilemma relates to the role of mothers who, to secure a better future for their children, are forced to leave them behind, thus subverting the traditional definition of motherhood. The absence of an egalitarian notion and the practice of citizenship for non-Jews leave undocumented labor migrants in Israel without prospects for incorporation into the society. (shrink)

We reconstruct “the classical transformational theory” of Chomsky, and fit it into the structuralist theory of science. We describe both the formal and the empirical features of this classical account, so that one basic hypothesis of this theory – where central notions are used – can be formulated, and in which Chomsky’s “classical” distinction between surface structure and deep structure is clarified. In the empirical claim of this theory are words, sentences and high-structured entities in an inseparable way intertwined. We (...) claim that the formal structure of a natural language is not approximately the same as that of an empirical theory in general. We clarify two special points which affect the structure of the notion of an empirical theory, namely: the delineation of intended applications and the fit between data and models. We hold that the concept of the empirical claim for a linguistic theory should be generalized in comparison with the “standard” structuralist approach. (shrink)

The main purpose of this study is the scientific practice of Edgard Roquette-Pinto at the National Museum of Rio de Janeiro during the 1910’s and 1920’s in the XXth Century. The article examines the relationship between laboratory science and nation building. Driven by Physicians-Anthropologists like Edgard Roquette-Pinto among others, the investigations performed at the Anthropology Laboratory there reveal the dynamic of the borders between Laboratory and Field Sciences, and the new biological parameters adopted at that time. The investigative agenda involved (...) plants, animals and human bodies, and it was related to the current Anthropology concept aligned with the debate of Nation construction. The physiological studies amplified the scientific exchange with different institutions, emphasizing cultural exchange between Brazil and Paraguay, and the role played by Edgard Roquette-Pinto there as he inaugurated the Physiological course at Faculty of Medicine at University of Asunción. (shrink)