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)

La presente investigación tuvo como objetivo realizar un análisis del procedimiento abreviado contemplado en el Código Orgánico Integral Penal (COIP), partiendo del criterio de que ciertos aspectos de este procedimiento vulneran derechos fundamentales del investigado. Se destaca particularmente el requisito para el procesado de admitir los hechos que se le imputan para acceder a este procedimiento, lo cual, según la opinión mayoritaria de doctrinarios, compromete el principio de no autoincriminación, la presunción de inocencia y el derecho a un juicio con (...) todas sus fases. El objetivo de esta investigación fue analizar el procedimiento abreviado establecido en el Código Orgánico Integral Penal (COIP), con el propósito de identificar posibles vulneraciones de derechos fundamentales del investigado. Se buscó específicamente evaluar cómo el requisito de admitir los hechos imputados para acceder a este procedimiento podría afectar principios como el de no autoincriminación y la presunción de inocencia. A través de un enfoque cualitativo y utilizando diferentes métodos de análisis, se procuró determinar si el procedimiento abreviado, tal como está configurado, garantiza un debido proceso conforme a los estándares de derechos humanos y constitucionales. La metodología aplicada se sustentó en un enfoque cualitativo, utilizando los métodos inductivo, analítico, sintético y exegético. Se llevó a cabo un análisis documental de la bibliografía relacionada con el tema investigado, así como de instrumentos internacionales de Derechos Humanos, la Constitución de la República de Ecuador, el COIP y jurisprudencia vinculada a la materia. Los resultados de la investigación determinaron que el procedimiento abreviado tal como se encuentra regulado en el COIP beneficia al Estado y al sistema de justicia al agilizar ciertos procesos legales. Sin embargo, se evidenció que este procedimiento puede vulnerar derechos esenciales del procesado, como el principio de no autoincriminación y la presunción de inocencia. Por lo tanto, se concluye que el procedimiento abreviado afecta el debido proceso al comprometer garantías fundamentales. La investigación señala que el procedimiento abreviado regulado en el COIP, si bien puede ser beneficioso para la eficiencia del sistema de justicia, también conlleva riesgos significativos de vulnerar derechos fundamentales del procesado. Por lo tanto, se destaca la necesidad de revisar y modificar este procedimiento para garantizar el respeto absoluto al debido proceso y a las garantías individuales del investigado. (shrink)

O texto apresenta um mapeamento exploratório inicial da realidade do ensino de filosofia no ensino fundamental e médio na rede de ensino público e privado de Teresina/PI, realizado no ano de 2000, objetivando disponibilizar dados para a organização dessa área de saber como o campo de atuação dos profissionais de filosofia e servir de subsídios à projeção das atividades da universidade na formação desses profissionais e na formulação de políticas de atuação do Departamento de Filosofia/UFPI junto ao ensino básico. O (...) resultado da pesquisa se apresenta na forma de diagnóstico exploratório de natureza quantitativa, especificando aspectos capazes de configurar a realidade da prática pedagógica do ensino de filosofia, tais como: a presença da disciplina no currículo escolar, a carga-horária conferida ao trabalho didático-pedagógico de filosofia, a formação acadêmica dos professores e professoras que ministram a disciplina, os conteúdos programáticos que predominam nos programas da disciplina, a bibliografia básica utilizada como apoio ao trabalho docente, a metodologia deste ensino e a recepção da disciplina entre os estudantes. (shrink)

El presente artículo es producto de una investigación multidisciplinaria e interinstitucional, fruto de la alianza entre la Universidad de San Buenaventura Medellín y el Centro de Familia VID-Obra de la Congregación Mariana de Medellín. Surge de una inquietud respecto a la manera en que se aborda la realidad institucional de las madres cabeza de familia, tanto en el ámbito político como empresarial. Para estudiar esta realidad, se partió de un modelo de investigación cualitativo, en donde se hizo una aproximación a (...) la población a partir de un cuestionario que permitiera identificar los roles y percepciones frente al ejercicio de la maternidad y la jefatura femenina, específicamente, cuando se trata de madres trabajadoras. Los resultados arrojados por la investigación permiten obtener una mirada psicosocial de la forma en que se ejerce el rol de madre y de figura de articulación familiar. (shrink)

Online crowdsourcing platforms have rapidly become a popular source of data collection. Despite the various advantages these platforms offer, there are substantial concerns regarding not only data validity issues, but also the ethical, societal, and global ramifications arising from the prevalent use of online crowdsourcing platforms. This paper seeks to expand the dialogue by examining both the “internal” aspects of crowdsourcing research practices, such as data quality issues, reporting transparency, and fair compensation, and the “external” aspects, in terms of how (...) the widespread use of crowdsourcing data collection shapes the nature of scientific communities and our society in general. Online participants in research studies are informal workers who provide labor in exchange for remuneration. The paper thus highlights the need for researchers to consider the markedly different political, economic, and socio-cultural characteristics of the Global North and the Global South when undertaking crowdsourcing research involving an international sample; such consideration is crucial for both increasing research validity and mitigating societal inequities. We encourage researchers to scrutinize the value systems underlying this popular data collection research method and its associated ethical, societal, and global ramifications, as well as provide a set of recommendations regarding the use of crowdsourcing platforms. (shrink)

(2006). Introduction. World Futures: Vol. 62, No. 3, pp. 153-156.

Potential applications of genome editing in assisted reproductive technology (ART) raise a vast array of strong opinions, emotional reactions and divergent perceptions. Acknowledging the need for caution and respecting such reactions, we observe that at least some are based on either a misunderstanding of the science or misconceptions about the content and flexibility of the existing legal frameworks. Combining medical, legal and ethical expertise, we present and discuss regulatory responses at the national, European and international levels. The discussion has an (...) EU starting point and is meant as a contribution to the general international regulatory debate. Overall, this paper concludes that gene editing technologies should not be regulated autonomously. Rather, potential uses should be regulated under general, existing frameworks and where applicable by reference to sufficiently equivalent technologies and techniques already subject to specific regulation. To be clear, we do not argue for the hasty introduction of gene editing as a reproductive treatment option in the immediate future. We call for caution with regard to overreaching moratoria and prohibitions that will also affect basic research. We recommend flexible regulations that allow for further responsible research into the potential development of the technology. We call for an open and inclusive debate and argue that scientific communication should claim a more prominent role to counter the danger of widespread misinformation. A high level of transparency and accuracy should guide scientific communication while simultaneously global‐scale responsibility and governance should be fostered by promoting cross‐disciplinary thinking and multi‐level stakeholder involvement in legal and regulatory processes. (shrink)

We present a reference model for finding evidence of discrimination in datasets of historical decision records in socially sensitive tasks, including access to credit, mortgage, insurance, labor market and other benefits. We formalize the process of direct and indirect discrimination discovery in a rule-based framework, by modelling protected-by-law groups, such as minorities or disadvantaged segments, and contexts where discrimination occurs. Classification rules, extracted from the historical records, allow for unveiling contexts of unlawful discrimination, where the degree of burden over protected-by-law (...) groups is evaluated by formalizing existing norms and regulations in terms of quantitative measures. The measures are defined as functions of the contingency table of a classification rule, and their statistical significance is assessed, relying on a large body of statistical inference methods for proportions. Key legal concepts and reasonings are then used to drive the analysis on the set of classification rules, with the aim of discovering patterns of discrimination, either direct or indirect. Analyses of affirmative action, favoritism and argumentation against discrimination allegations are also modelled in the proposed framework. Finally, we present an implementation, called LP2DD, of the overall reference model that integrates induction, through data mining classification rule extraction, and deduction, through a computational logic implementation of the analytical tools. The LP2DD system is put at work on the analysis of a dataset of credit decision records. (shrink)

The general question to be considered in this paper points to the nature of the world described by chemistry: what is macro-chemical ontology like? In particular, we want to identify the ontological categories that underlie chemical discourse and chemical practice. This is not an easy task, because modern Western metaphysics was strongly modeled by theoretical physics. For this reason, we attempt to answer our question by contrasting macro-chemical ontology with the mainstream ontology of physics and of traditional metaphysics. In particular, (...) we introduce the distinction between stuff-ontology, proper of chemistry, and individual-ontology, proper of physics. These two ontologies differ from each other in the basic categories of their own structures. On this basis, we characterize individual-ontology in such a way that the features of stuff-ontology will arise by contrast with it. (shrink)

The target article by Grady and colleagues (2008) is a valuable and exciting contribution to the debate about the importance of ethics education for nurses. The findings indicated that ethics educa...

This paper describes a practice innovation: the addition of formal weekly discussions of patients with prolonged PICU stay to reduce healthcare providers’ moral distress and decrease length of stay for patients with life-threatening illnesses. We evaluated the innovation using a pre/post intervention design measuring provider moral distress and comparing patient outcomes using retrospective historical controls. Physicians and nurses on staff in our pediatric intensive care unit in a quaternary care children's hospital participated in the evaluation. There were 60 patients in (...) the interventional group and 66 patients in the historical control group. We evaluated the impact of weekly meetings to establish goals of care for patients with longer than 10 days length of stay in the ICU for a year. Moral distress was measured intermittently and reported moral distress thermometer scores fluctuated. "Clinical situations" represented the most frequent contributing factor to moral distress. Post intervention, overall moral distress scores, measured on the moral distress scale revised, were lower for respondents in all categories, and on three specific items. Patient outcomes before and after PEACE intervention showed a statistically significant decrease in PRISM indexed LOS, a statistically significant increase in both code status changes DNR, and in-hospital death, with no change in patient 30 or 365 day mortality. The addition of a clinical ethicist and senior intensivist to weekly inter-professional team meetings facilitated difficult conversations regarding realistic goals of care. The study demonstrated that the PEACE intervention had a positive impact on some factors that contribute to moral distress and can shorten PICU length of stay for some patients. (shrink)

A Lei de Diretrizes e Bases 9.394/96 inseriu a Filosofia nos currículos do Ensino Médio com o indicativo de interdisciplinaridade, permanecendo em aberto questões acerca de como fazer com que a Filosofia potencialize a experiência interdisciplinar. Com o objetivo de correlacionar interdisciplinaridade e Filosofia, o artigo resulta de uma análise hermenêutica que confronta reflexões de Hannah Arendt sobre a crise na educação e a proposta da comunidade de investigação de Lipman. Parte da noção de que em meados do século XX, (...) a educação tradicional foi substituída pela pedagogia progressista e a educação passou a ser pensada como ciência do ensino em geral, a fim de atender à dinâmica do avanço científico e tecnológico. A visão analítica e linear das especialidades não responde satisfatoriamente às demandas atuais de uma ciência complexa, articulada e em rápida transformação. Diante do requisito interdisciplinar da ciência, o específico da Filosofia é a problematização e a sistematização do filosofar; de mediação entre as disciplinas, em virtude da dimensão holística de seus conteúdos, e de vigilância epistemológica como recurso de revisão e atualização dos saberes. Palavras-chave: Interdisciplinaridade. Filosofia. Ciência. Crise na educação. Comunidade de investigação. (shrink)

El objetivo de este texto es investigar sobre los posibles puntos de encuentro entre la psicoterapia existencial, un paradigma psicológico arraigado en las filosofías de la existencia, y el posicionamiento del profesor Marino Pérez Álvarez, quien se define a sí mismo como conductista radical, respecto a su manera de entender la existencia humana y el modelo más adecuado de psicoterapia. Para ello se proponen seis puntos de encuentro: necesidad de una fundamentación filosófica para la psicología, crítica al cientificismo y al (...) modelo médico, interpretación de los trastornos mentales como problemas de la vida cotidiana, recuperación del paciente como protagonista de la terapia, crítica a la psicología positiva y crítica al dualismo cartesiano. (shrink)

In late February and early March 2020, Italy became the European epicenter of the COVID-19 pandemic. Despite increasingly stringent containment measures enforced by the government, the health system faced an enormous pressure, and extraordinary efforts were made in order to increase overall hospital beds’ availability and especially ICU capacity. Nevertheless, the hardest-hit hospitals in Northern Italy experienced a shortage of ICU beds and resources that led to hard allocating choices. At the beginning of March 2020, the Italian Society of Anesthesia, (...) Analgesia, Resuscitation, and Intensive Care issued recommendations aimed at supporting physicians in prioritizing patients when the number of critically ill patients overwhelm the capacity of ICUs. One motivating concern for the SIAARTI guidance was that, if no balanced and consistent allocation procedures were applied to prioritize patients, there would be a concrete risk for unfair choices, and that the prevalent “first come, first served” principle would lead to many avoidable deaths. Among the drivers of decision for admission to ICUs, age, comorbidities, and preexisting functional status were included. The recommendations were criticized as ageist and potentially discriminatory against elderly patients. Looking forward to the next steps, the Italian experience can be relevant to other parts of the world that are yet to see a significant surge of COVID-19: the need for transparent triage criteria and commonly shared values give the Italian recommendations even greater legitimacy. (shrink)

Este artigo faz uma análise da brasileira Clarice Lispector enquanto escritora e por meio das suas pinturas produzidas na década de 1970. Nas obras literárias da autora é evidente sua angústia e, através do pincel, a escritora também deixou transparecer todo seu sentimento em relação à existência em-si.

Avec un taux de 31 % de députées au Bundestag, l’Allemagne est loin de la parité en politique. Cet article vise à éclairer les raisons, tant institutionnelles que discursives, qui participent de cet état de fait. Dans un premier temps, il sera question des mécanismes qui freinent l’accès des femmes à la députation : la femme cantonnée à la sphère privée, l’image de la femme apolitique, les pratiques au sein des partis ainsi que le mode de scrutin. Au niveau institutionnel, (...) des solutions concrètes émergent, à l'image des quotas paritaires mis en place au sein des partis. D’autres solutions sont actuellement discutées, notamment un éventuel changement du mode de scrutin. Dans un second temps, nous verrons que même une fois ce premier pas vers la députation franchi, l’activité des députées demeure liée à des problématiques spécifiques de genre qui se manifestent sur le plan linguistique, par exemple au travers d'interruptions sexistes pendant leurs discours. (shrink)

Enaction, as put forward by Varela and defended by other thinkers (notably Alva Noë, 2004; Susan Hurley, 2006; and Kevin O’Regan, 1992), departs from traditional accounts that treat mental processes (like perception, reasoning, and action) as discrete, independent processes that are causally related in a sequen- tial fashion. According to the main claim of the enactive approach, which Thompson seems to fully endorse, perceptual awareness is taken to be a skill-based activity. Our perceptual contact with the world, according to the (...) enactionists, is not mediated by representations but is enacted, and the notion of representation, belonging to the classic computational paradigm, has no place in this alternative approach. Though Thompson does not pronounce directly on the issue of representationalism, he is most definitely keeping the company of anti-representationalists, and in that context it is not unreasonable to take his silence for consent. In this paper, we will argue that the enactive approach to imagery is unworkable unless it makes appeal to representations, understood in a particular way. Not understood as pictures, to be sure. Or sentences for that matter. But those aren’t the only options. (shrink)

Although the literature on corporate social responsibility has discussed the scope and meaning of CSR extensively, confusion still exists regarding how to define the concept. One controversial issue deals with the changing legal status of CSR. Based on a review of CSR definitions and meta-studies on CSR definitions, we find that the majority of definitions leans toward voluntary CSR. However, some recent regulatory amendments toward mandatory CSR have called into question the established idea of CSR as merely a managerial tool (...) of self-regulation. In this paper, we juxtapose the evolution of CSR in India against the scholarly literature discussing voluntary-versus-mandatory CSR to understand the recent shift toward a new conceptualization of CSR as a form of co-regulation that includes elements of both voluntary and mandatory regulation. The Indian Companies Act 2013 is a remarkable example in that it replaced an older version from 1956, taking a bold step toward the integration of voluntary and mandatory aspects in the application of CSR. We present practical implications of the Indian case for businesses and discuss implications for CSR theory development; we particularly consider the evolution of the business and society relationship from a voluntary soft law approach to CSR to an increasingly hard law approach and transitory hybrid forms in-between like soft–hard law and hard–soft law. (shrink)