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)

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)

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)

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 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)

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

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)

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)

Words like "terrorism" and "war" no longer encompass the scope of contemporary violence. With this explosive book, Adriana Cavarero, one of the world's most provocative feminist theorists and political philosophers, effectively renders such terms obsolete. She introduces a new word—"horrorism"—to capture the experience of violence. Unlike terror, horrorism is a form of violation grounded in the offense of disfiguration and massacre. Numerous outbursts of violence fall within Cavarero's category of horrorism, especially when the phenomenology of violence is considered from (...) the perspective of the victim rather than that of the warrior. Cavarero locates horrorism in the philosophical, political, literary, and artistic representations of defenseless and vulnerable victims. She considers both terror and horror on the battlefields of the _Iliad_, in the decapitation of Medusa, and in the murder of Medea's children. In the modern arena, she forges a link between horror, extermination, and massacre, especially the Nazi death camps, and revisits the work of Primo Levi, Hannah Arendt's thesis on totalitarianism, and Arendt's debate with Georges Bataille on the estheticization of violence and cruelty. In applying the horroristic paradigm to the current phenomena of suicide bombers, torturers, and hypertechnological warfare, Cavarero integrates Susan Sontag's views on photography and the eroticization of horror, as well as ideas on violence and the state advanced by Thomas Hobbes and Carl Schmitt. Through her searing analysis, Caverero proves that violence against the helpless claims a specific vocabulary, one that has been known for millennia, and not just to the Western tradition. Where common language fails to form a picture of atrocity, horrorism paints a brilliant portrait of its vivid reality. (shrink)

Twinned 2H martensite is observed in copper-based shape memory alloys together with basal and non-basal plane stacking faults. Knowledge of the twin-boundary structure and its interaction with the faults is important to understand the deformation mechanism by twin coalescence. High-resolution electron microscopy coupled with image simulations have been used for these studies. The interface of the type I twinning in 2H martensite shows an atomic configuration with mirror antisymmetry. An atomic plane is shared by the twinned variants in such a (...) way that the distance between the planes, parallel to the interface, is unchanged at the boundary and the mean atomic volume is conserved. The interaction of the boundary with a basal plane fault generates a shift in the interface. A mirror antisymmetrical boundary is maintained by introducing an imperfect interface dislocation. (shrink)

Tekst nastoji ponuditi drugačiju paradigmu razumijevanja identiteta genealoškim čitanjem figure guvernante u Engleskoj XIX. stoljeća. Pokazujući da je ovu figuru nemoguće razumjeti ukoliko se uklone iz vida klasne pretpostavke njenog rodnog identiteta, i specifične pozicije koju je zauzimala na tržištu rada i u proizvodnji drugih žena, tekst nastoji dovesti u pitanje kontekst patrijarhata kao kontekst koji omogućava definiranje identiteta žene. Umjesto tog okvira, tekst pokušava uvesti drugačiji okvir koji se razrađuje kao sustav privatnog i javnog.

This work employs Elizabeth Cripps’ collectivist account of responsibility for climate change in order to ground an individual duty to reduce one’s GHG emissions. This is significant not only as a critique of Cripps, but also as an indication that even on some collectivist footings, individuals can be assigned primary duties to reduce their emissions. Following Cripps, this work holds the unstructured group of GHG emitters weakly collectively responsible for climate change harms. However, it argues against Cripps that what follows (...) from this is a corresponding collective duty to act qua group to bring about an end to the harm and a derivative duty for each emitter to promote the required organization of a group capable of this. Instead, this work argues that acts of GHG emission, to the extent that they are avoidable and performed with requisite knowledge, make one into a member of a group that is morally responsible for climate-related harms. Thus, individual emitters who can do otherwise should recognize themselves as members of a group that collectively harms. Subsequently, they should take all possible steps in order to renounce their membership (e.g. by reducing their GHG emissions). (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)

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)

Voltada ao enfoque mais específico de pensar a condição da Filosofia na universidade, esta obra traz diversas contribuições de professores e pesquisadores que têm se dedicado ao assunto. Em linhas gerais, seu conteúdo discute a noção de Estado republicano em relação à Filosofia e às instituições de ensino. Pensa os currículos, a especificidade da aprendizagem e do saber filosóficos, bem como os parâmetros da pesquisa em Filosofia na universidade. Além disso, reflete sobre as condições de inserção da Filosofia na Educação (...) Básica e no contexto das novas tecnologias, que traz a modalidade do ensino a distância. (shrink)

ABSTRACT This paper deals with two cases of acquisition and construction of Van de Graaff accelerators in 1950s Latin America, at the National Autonomous University of Mexico and the University of São Paulo, respectively. A comparative approach allows us to appreciate the significance of this particular technology within scientific, cultural, commercial, and political processes. Van de Graaff accelerators appeared as an affordable technology to engage in experimental nuclear physics and to be part of the atomic age. The circumstances that motivated (...) physics communities in Brazil and Mexico to choose this specific technology took shape in close interactions with US institutions and scientists. These inter-American alliances involved precisely the main companies and groups that competed for the market of this technology around the world. These accelerators also intertwined with the building of campuses for two major Latin American universities, occupying then a singular place (physically and symbolically) within their execution. This paper engages with comparison for the common goal of going beyond frameworks and methodologies tied to the nation, while integrating the study of connections and interactions, as well as the interplay of multiple scales. (shrink)

Medellín has been a privileged subject in Colombian cinema. In films whose stories take place in Medellín and movies' plots that revolve around the production of Medellín’s space, themes like social exclusion and violence become representational elements associated to marginality and segregation, as well as to struggles over the control of the urban territory and its correlates expressed on female and male bodies. By drawing on emotional geography, this article examines these films to explain how Medellín is constructed visually and (...) discursively to elaborate stories based on segregation, exclusion along race and class, and the armed conflict that Colombia has experienced in its recent history, a conflict of which Medellín has been a battleground. Additionally, it becomes clear that social conflict in Medellín is a multi-scalar process. The ways in which political and social tensions have been experienced in the city—and their correlates in the production of urban spaces—are fundamentally shaped by the nature and structure of the urban territories where conflict materializes. In visual narratives, stories unfold at these multiple sites of urban conflict. These topics are representations built on dichotomies like inclusion/exclusion, center/periphery, and masculine/feminine, depicting Medellín as an ill city, an urban collection of geographies that suffer from an illness of which drug trafficking is its main cause and violence its main symptom. (shrink)

In On Nature and Language Noam Chomsky develops his thinking on the relation between language, mind and brain, integrating current research in linguistics into the burgeoning field of neuroscience. This 2002 volume begins with a lucid introduction by the editors Adriana Belletti and Luigi Rizzi. This is followed by some of Chomsky's writings on these themes, together with a penetrating interview in which Chomsky provides the clearest and most elegant introduction to current theory available. It should make his Minimalist (...) Program accessible to all. The volume concludes with an essay on the role of intellectuals in society and government. Nature and Language is a significant landmark in the development of linguistic theory. It will be welcomed by students and researchers in theoretical linguistics, neurolinguistics, cognitive science and politics, as well as anyone interested in the development of Chomsky's thought. (shrink)

This paper is concerned with events that were the subject of an inquest into the deaths of 12 children who died while undergoing or shortly after having undergone cardiac surgery at the Winnipeg Health Sciences Centre, Manitoba, Canada, during 1994. A notable finding of the Sinclair Inquest was that nurses involved with the pediatric cardiac surgery program were concerned about the competence of the surgeon and made sustained efforts throughout 1994 to have these concerns addressed. That the nurses’ concerns were (...) not taken seriously is the central problem of this paper. Essentially, the position articulated is that gendered and gendering discourses constituted a form of power that structured the field of nurses’ possible actions. These discourses constituted a resource to make nurses knowable, to produce them as certain forms of the person, and were therefore part of what governed nurses everyday conduct. Though neither simply good nor bad in themselves, in this case, these discourses had constraining effects on how nurses were able to conduct themselves. (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)

In this paper we review the factors alleged to be responsible for the creation of inaccurate reports among preschool-aged children, focusing on so-called "source misattribution errors." We present the first round of results from an ongoing program of research that suggests that source misattributions could be a powerful mechanism underlying children′s false beliefs about having experienced fictitious events. Preliminary findings from this program of research indicate that all children of all ages are equally susceptible to making source misattributions. Data from (...) a follow-up wave of data indicate that very young children may be disproportionately vulnerable to these kinds of errors when the procedure is changed slightly to create mental images more easily. This vulnerability leads younger preschoolers, on occasion, to claim that they actually experienced events that they only thought about. These preliminary findings are discussed in the context of the ongoing debate over the veracity and durability of delayed reports of early memories, repressed memories, dissociative states, and the validity risks posed by therapeutic techniques that entail repeated visually guided imagery inductions. (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.

We argue that Henrich et al. do not go far enough in their critique: Sample diversification, while important, will not lead to the detection of generalizable principles. For that it will be necessary to broaden the range of contexts in which data are gathered. We demonstrate the power of contexts to alter results even in the presence of sample diversification.

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 article begins by surveying the names of the Father and their occurrences in the Cassiciacum Dialogues, then moves from language to ideas. It explores the meaning, sources and content of notions associated with each named Father. It concludes with a philosophical synthesis focused on the theoretical features of the figure of “the Father”, which conforms with Christian faith as interpreted through careful use of neoplatonic thought.

In this article, we interpret sex education from the perspective of feminist care ethics, emphasizing the concept of caring democracy, advanced by Joan Tronto one of the most influential feminist political theorists. According to Tronto, these theories show that a deficit of care and a lack of democracy are mutually conducive. We argue that, as in other areas of life, a lack of care in sexuality and sex education leads to social inequalities that eventually translate into an unequal approach to (...) freedom, equality, and justice, and to a deficit of democracy in the lives of some people. At the same time, we believe that, as a moral theory, care ethics, with its emphasis on the needs of men and women, can be adequately applied to the design of research projects, as well as to sexuality policies and practices. This may contribute to overcoming the stalemate in the debate on sex education and other topics in Slovakia. (shrink)