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)

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)

Over the past three decades, economic sociology has been revealing how culture shapes economic life even while economic facts affect social relationships. This work has transformed the field into a flourishing and increasingly influential discipline. No one has played a greater role in this development than Viviana Zelizer, one of the world's leading sociologists. Economic Lives synthesizes and extends her most important work to date, demonstrating the full breadth and range of her field-defining contributions in a single volume for (...) the first time. Economic Lives shows how shared cultural understandings and interpersonal relations shape everyday economic activities. Far from being simple responses to narrow individual incentives and preferences, economic actions emerge, persist, and are transformed by our relations to others. Distilling three decades of research, the book offers a distinctive vision of economic activity that brings out the hidden meanings and social actions behind the supposedly impersonal worlds of production, consumption, and asset transfer. Economic Lives ranges broadly from life insurance marketing, corporate ethics, household budgets, and migrant remittances to caring labor, workplace romance, baby markets, and payments for sex. These examples demonstrate an alternative approach to explaining how we manage economic activity--as well as a different way of understanding why conventional economic theory has proved incapable of predicting or responding to recent economic crises. Providing an important perspective on the recent past and possible futures of a growing field, Economic Lives promises to be widely read and discussed. (shrink)

My paper proposes the concept of relational work to explain economic activity. In all economic action, I argue, people engage in the process of differentiating meaningful social relations. For each distinct category of social relations, people erect a boundary, mark the boundary by means of names and practices, establish a set of distinctive understandings that operate within that boundary, designate certain sorts of economic transactions as appropriate for the relation, bar other transactions as inappropriate, and adopt certain media for reckoning (...) and facilitating economic transactions within the relation. I call that process relational work. After identifying specific elements of a relational work approach, the paper focuses on the case of monetary differentiation. It compares a relational work theory of earmarking money with behavioral economics’ individually based mental accounting approach. (shrink)

The quest for real democracy is one of the components of sustainable degrowth. But the incipient debate on democracy and degrowth suffers from general definitions and limited connections to political philosophy and democracy theory. This article offers a critical review of democracy theory within the degrowth literature, taking as its focal point a relevant debate between Serge Latouche and Takis Fotopoulos. We argue that the core of their contention can be traced back to the relationship between the concepts of democracy (...) and autonomy as defined by philosopher Cornelius Castoriadis, which both authors and generally the degrowth movement consider as one of their theoretical reference points. We show how both Latouche and Fotopoulos hold a misconception of Castoriadis' notions of autonomy, the social imaginary and politics, which in turn limits their cognisance of democracy and hence confuses their debate concerning the possibilities for a degrowth transition within the confines of a liberal parliamentary democracy. With a clarified theoretical understanding of the interconnected democracy-autonomy assemble, we proceed to an evaluation of the revolutionary potential of the degrowth movement and to a better understanding of a possible relationship between democracy and degrowth. (shrink)

This paper reports the framework, method and main findings of an analysis of cultural milieus in 4 European countries. The analysis is based on a questionnaire applied to a sample built through a two-step procedure of post-hoc random selection from a broader dataset based on an online survey. Responses to the questionnaire were subjected to multidimensional analysis-a combination of Multiple Correspondence Analysis and Cluster Analysis. We identified 5 symbolic universes, that correspond to basic, embodied, affect-laden, generalized worldviews. People in this (...) study see the world as either a) an ordered universe;b) a matter of interpersonal bond;c) a caring society;d) consisting of a niche of belongingness;e) a hostile place. These symbolic universes were also interpreted as semiotic capital: they reflect the capacity of a place to foster social and civic development. Moreover, the distribution of the symbolic universes, and therefore social and civic engagement, is demonstrated to be variable across the 4 countries in the analysis. Finally, we develop a retrospective reconstruction of the distribution of symbolic universes as well as the interplay between their current state and past, present and future socio-institutional scenarios. (shrink)

Este trabajo se enmarca dentro del análisis de las acciones alternativas a la privación de libertad en adolescentes infractores a la ley penal. Intenta buscar soluciones que eviten la cárcel para quienes cometan pequeños delitos, opción que puede disminuir el índice de reincidencias. El objetivo es promover, desde el Trabajo Social, una doble reflexión: primero, analizando críticamente el concepto de delito, su definición en las diversas corrientes ideológicas y su aplicación en la legislación argentina; y segundo, la importancia de que (...) los jóvenes se responsabilicen de sus actos y experimenten caminos alternativos al delito.This work places inside the analysis of the alternative actions to the privation of freedom in inobservant teenagers to the penal law. It tries to look for solutions that avoid the jail for those who commit small crimes, option that can diminish the index of repetitions. The aim is to promote, from the Social Work, a double reflection: first, analyzing critically the concept of crime, his definition in the diverse ideological currents and his application in the argentine legislation; and second, the importance of which the young men take responsibility of his acts and experience alternative ways to the crime. (shrink)

Changemaker Education is a collection of practitioner-based case studies that highlight the why, what, and how of empowering educational experiences.

Indirect speech is a remarkable trait of human communication. The present paper tackles the sociobiological underpinnings of communicative indirectness discussing both socio-interactional and cognitive rationales behind its manifestation in discourse. From a social perspective, the use of indirect forms in interactions can be regarded as an adaptive response to the epistemic implications of transacted new information in small primary groups, representing – in Givón’s terms – our “bio-cultural” descent. The design features of indirect strategies today may therefore be explained in (...) terms of a form-function mapping in which indirect communicative expressions allowed a “safer” transaction of contents and a more cooperative attitude of speakers in both face-to-face and public contexts of communication. The unchallengeability effects notably induced by underencoded meanings have now received extensive experimental backing, unveiling intriguing underlying cognitive mechanisms such as the well-known cognitive illusions or fallacies. (shrink)

Este trabajo se propone examinar algunas características de la máscara del coquus en el corpus plautino. En primer término, se estudia el modo en que este personaje, a partir de las referencias al castigo físico y a la pasividad sexual, es construido como un cuerpo subordinado al servicio de otros. Luego, se consideran sus apariciones como ladrón y como proveedor de placeres corporales. Proponemos que la forma en que los cocineros son representados en la palliata de Plauto pone en evidencia (...) el vínculo que la axiología republicana establece entre actores sociales subalternos, corporalidad y amenaza a los mores maiorum. This paper examines some characteristics of the coquus mask in the plautine corpus. First, we study how this character, from references to physical punishment and sexual passivity, is built as a subordinate body to the service of others. Then, we consider his appearances as a thief and a provider of bodily pleasures. We propose that the way cooks are represented in Plautus' palliata shows us the link established by Republican axiology between subaltern social actors, body and threat to mores maiorum. (shrink)

This study examines how multinational corporations’ subsidiaries manage institutional complexity when deploying their corporate social responsibility activities in Africa. Building on insights from international business studies of CSR and recent development in comparative institutionalism, we explore how distinct institutional forces combine to shape subsidiary’s CSR behaviour across five African countries. Relying on 33 interviews with managers at 26 subsidiaries operating in Angola, Egypt, Ghana, Kenya and South Africa, we identified patterns of variations in CSR deployment across these countries. Our findings (...) reveal that MNCs’ subsidiaries mobilize the CSR strategy of their parent firm to demonstrate their compliance with their headquarters’ expectations, but also complement this minimum level of requirement with elements that reflect the needs from the local business system. As a whole, our findings reveal the complex bricolage undertaken by subsidiary’s managers to tailor their CSR strategy in ways that meet the contradictory institutional forces they face. (shrink)

Comentarios sobre "Demographic Behaviour and Behaviour Genetics o Comportement démographique et génetique du comportement", de Atam Vetta y Daniel Courgeau*.

“Fueron, son, compañeras. Compañeras, las que comparten el pan. Eso significa la palabra, según su raíz latina. Este libro comparte y libera la memoria. Es la obra colectiva de muchas presas. De la última dictadura argentina. Ellas testimonian de los secretos soles que escondían aquella noche”.Estas palabras corresponden al discurso de Eduardo Galeano, en la presentación del libro Nosotras, las presas políticas, actividad realizada en la sala Jorge Luis Borges, en el año 2006, en la Feria de..

La relación entre el arte y la naturaleza fue concebida a lo largo de más de veinte siglos en los términos que Aristóteles estableció mediante el principio téchne mimeîtai phúsin, el cual tradicionalmente se tradujo como “el arte imita a la naturaleza”. Mediante el presente artículo propongo reevaluar la formulación completa del principio aristotélico con el propósito de entender que éste no solo refiere a la similitud y/o analogía entre las habilidades humanas y la naturaleza, sino también al papel complementario (...) que estas desempeñan respecto de la naturaleza. En la primera parte del trabajo, examino las distintas enunciaciones del principio atestiguadas en el corpus. En la segunda, analizo la función que la política y su principal herramienta, la educación, cumplen respecto de la naturaleza. (shrink)

The purpose of this article is to construct a critique of some works by the French artist Lucy Schwob, better known as Claude Cahun, who was active between 1910 and 1950. A writer and photographer, Cahun was at first very close to symbolist positions; later she was closer to the surrealist movement. Her work and her life, continually suspended between genders, and between ‘normality’ and ‘deviance’, have so far been analysed mainly through gender studies. This article attempts to restore the (...) inherent complexity of her poetic work and aesthetic. It tries to widen the field of study to deal with the representation of alterity, through reversing the stereotypical representation. (shrink)

La metafora della luce di origine dionisiana esaminata come strumento di conoscenza che si traduce in pratica di vita.

El presente articuLo pretende encuadrar y definir las implicaciones éticas reLativas a La aplicación biomédica de las nanotecnologías, a través de La vaLoración deL estado del arte.Las nanotecnologías, expresiÓn de La habilidad humana de manipuLar la materia a escala atómico/molecular se presentan como un instrumento capaz de modificar la investigaciÓn científica y la medicina de manera radicaL.Debates a todo nivel han subrayado las dificultades de darles una definición clara y unívoca, a causa de la convergencia de diversos ámbitos del saber (...) comprendidos en ellas.No obstante que Las nanotecnoLogías estén ya presentes en las ciencias computacionaLes y en La eLectrÓnica, es en eL ámbito médico-sanitario que se proyectan Las aplicaciones más entusiastas: instrumentos de diagnóstico y suministración de fármacos menos invasivos y más eficaces. Estas tecnoLogías se presentan al mismo tiempo como terapias pero también como instrumentos de prevención únicos, Las mismas características que hacen peculiar eL empLeo de las nano tecnologías en medicina, sugieren también precauciones: por una parte la dimensión mínima de las nanopartículasfacilita su ingreso en el organismo humano, traspasando las defensas naturales del organismo, agilizando una distribuciÓn de los fármacos altamente precisa. Por otra parte, estas mismas características pueden revelarse dañinas para el organismo humano .Dado que se trata de tecnología en rápida progresiÓn cuyos adelantos no son fáciles de predecir. los riesgos, aunque sÓlo aquellos potenciales, deben ser cuidadosamente valorados ya sea para las aplicaciones presentes como para aquellas futuras.Por tanto, encuadrar las implicaciones bioéticas de las nanotecnologías significa comprender y valorar su impacto sobre la salud humana. (shrink)

En el contexto de alta judicialización del sistema escolar, un fallo del Tribunal Constitucional de Chile pone en evidencia cuestiones relativas a la garantía de igualdad y las condiciones razonables que la diferencia, como argumentos de inaplicabilidad de la Ley de Inclusión en materia de admisión escolar. Sigue siendo una problemática garantizar el derecho a la igualdad de oportunidades educativas, que no solo sea una garantía de acceso, sino que aborde la desigualdad existente en materia social, económica, cultural y también (...) educativa. Por medio del análisis crítico a una sentencia en particular, se abordan las conceptualizaciones sobre la igualdad, desde la revisión de la literatura especializada con autores clásicos y actuales. En esta búsqueda conceptual se exponen argumentos hacia una mirada polisémica de las igualdades en el contexto escolar, se descubre que las desigualdades que subyacen en el acto de igualar, que para aproximarse a la justa igualdad de oportunidades se debe favorecer a los desfavorecidos y desfavorecer a los favorecidos, que las diferencias en las capacidades generan igualdades. Es en este dilema que aparenta antonomasia, igualdad y desigual, se develan contradicciones y paradojas que permiten dilucidar a “las escuelas” en las diferencias estructurales de la igualdad educativa, en esta intención histórica de las políticas públicas de igualar la cancha, igualar la partida, igualar la llegada. (shrink)

Fahr’s disease is a rare idiopathic degenerative disease characterized by calcifications in the brain, and has also been associated with balance impairment. However, a detailed analysis of balance in these patients has not been performed. A 69-year-old woman with Fahr’s disease presented with a long-lasting subjective imbalance. Balance was analyzed using both clinical and instrumented tests. The patient’s balance was normal during clinical tests and walking. However, during standing, a striking impairment in vestibular control of balance emerged. The balance behavior (...) displayed mixed parkinsonian and cerebellar features, with a discrepancy between the high severity of the static and the low severity of the dynamic balance impairment. The balance impairment characteristics outlined in this study could help neurologists and physiatrists detect, stage, and treat this rare condition. (shrink)