This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have (...) been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. (shrink)

This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The demand for pharmaceutical products (...) in the country has been increasing by double digits over the last few years, reaching 20% in 2008. Not surprisingly, we are also witnessing a steady increase in the number of applications by national and international pharmaceutical companies before ethical research authorities for authorization to perform clinical trials of drugs. (shrink)

As health policy-makers around the world seek to make progress towards universal health coverage, they must navigate between two important ethical imperatives: to set national spending priorities fairly and efficiently; and to safeguard the right to health. These imperatives can conflict, leading some to conclude that rights-based approaches present a disruptive influence on health policy, hindering states’ efforts to set priorities fairly and efficiently. Here, we challenge this perception. We argue first that these points of tension stem largely from inadequate (...) interpretations of the aims of priority setting as well as the right to health. We then discuss various ways in which the right to health complements traditional concerns of priority setting and vice versa. Finally, we set out a three-step process by which policy-makers may navigate the ethical and legal considerations at play. (shrink)

We argue that deliberative decision-making that is inclusive, transparent and accountable can contribute to more trustworthy and legitimate decisions on difficult ethical questions and political trade-offs during the pandemic and beyond.

Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES (...) FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher. (shrink)

Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES (...) FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher. (shrink)

What makes solitude a positive experience? What distinguishes experiences of solitude from experiences of loneliness? We review some of the literature on the benefits of solitude, focusing on freedom, creativity, and spirituality. Then, we argue that the relationship between agent and environment is an important factor in determining the quality of experiences of solitude. In particular, we find that solitude may support a person’s sense of agency, expanding the possibilities for action that a person has, and creating the conditions for (...) authenticity. We describe a phenomenology of solitude, based on a study that explores the nature of experiences of loneliness and solitude in a religious community. One finding is that solitude is characterised by presence, whereas loneliness is characterised by absence. Another finding is that solitude can contribute to a sense of empowerment that enables agents to pursue and achieve the goals they find valuable. (shrink)

Introduction Context: In Portugal assisted death was approved in February 2020 by the Parliament, although the law is not yet in force. Objectives To find out what doctors think about those practices. Methods A link to a questionnaire was sent by email three times, at intervals of one week, to the doctors registered in the Northern Section of the Portuguese Medical Association, before the Parliamentary approval. Results The questionnaire was returned by 1148 physicians. A minority of doctors would practice a (...) form of assisted death under the present law or if it was legalized, but a higher percentage think that euthanasia should be legalized, and more would like to have that option if they themselves were in a terminal phase of a disease. Religion has a strong influence on the attitudes of doctors, so too does their contact with patients in a terminal phase, as doctors who deal with more patients with far advanced diseases are more likely to be unfavorable to assisted death. On the other hand, younger doctors are more in favor of these practices. Conclusion The small percentage of questionnaires sent back is a weakness in this study and casts doubts on the generalizability of the conclusions. However, this is, so far, the best approximation to the opinions of Portuguese doctors on assisted death. (shrink)

Media ecology is not the theoretical stream of communication studies and it is not limited to Marshall McLuhan´s work and thinking; however, we focus on McLuhan’s approach to media ecology for this special issue on the philosophy of Marshall McLuhan. Media ecology is a complex and systemic metadiscipline whose object of study is the changes and effects that have occurred in society as a result of the evolution of technology and media throughout history.

The aim of this paper is to show that an introductory step to the Neoplatonic exegesis of the dialogue was to redefine the figure of Socrates and Socratism, so as to offer aspiring Platonists a correct interpretation of Plato and of the Neoplatonic metaphysical system. In the final stages of a long tradition, Socrates became the teacher par excellence not only of Plato but of all Platonists. In particular, by focusing on the Prolegomena to Platonic philosophy I wish to highlight (...) the fact that, when it comes to teaching, there is no Socrates but Plato’s teacher, a teacher whose many voices – universalised according to well-defined criteria – can also be attributed to Plato. If Plato came to be seen as polyphonic and always self-consistent, this is probably because it was possible to show that Socrates’ hallmark was his ability to remain consistent while expressing many different opinions in the dialogues. (shrink)

RESUMEN Se analiza si la versión de la justicia como equidad, presentada en El liberalismo político, es genuinamente una concepción política. Se examina el problema de la razonabilidad de las doctrinas comprehensivas, y se indaga luego si el argumento en dos etapas afecta la integridad estructural del liberalismo político. Se concluye que J. Rawls fracasa en su intento de justificar un liberalismo independiente de una doctrina comprehensiva de carácter liberal. ABSTRACT The article analyzes whether the conception of justice as fairness, (...) set forth by Rawls in Political Liberalism, is a genuine political conception. It first examines the issue of reasonableness of comprehensive doctrines and then goes on to inquire whether the two-step argument affects the structural integrity of political liberalism. The paper concludes that J. Rawls fails in his attempt to justify liberalism independently of a comprehensive liberal doctrine. (shrink)

This volume examines the philosophical sources of the Kantian concepts "apperception" and "self-consciousness", the historical development of the theories of apperception and deduction of categories within the pre-critical period, the structure and content of A- as well as B-deduction of categories, and finally the Kantian meaning of "apperception" and "self-consciousness".

En este trabajo se hace un análisis aproximativo del estudio fenomenológico hermenéutico del dolor en la facticidad del vivir propio. Su objetivo es visualizar el dolor como determinante en la apertura a la existencia del ser, del ser-ahí, en perspectiva heideggeriana. Se expone la experiencia de la vida dolorosa como experiencia fáctica del vivir en sí mismo, y el conflicto ético que plantea la alteridad: la dificultad de comprender el dolor de los otros desde su propio experimentar dolor. Este conflicto (...) ético aparece en la conciencia del médico cuando éste asume el compromiso de ir más allá de la ayuda instrumental e intenta ver el sufrimiento del enfermo desde la realidad del otro como sí mismo. La hipótesis que subyace en este análisis es que el sufrimiento del dolor abre camino a la existencia propia; sin embargo, evidencia el obstáculo de comprensión del otro. Se concluye ratificando la idea de que el dolor tiene carácter de «existenciario» (término de Martin Heidegger, que significa un modo de ser-en-el-mundo). (shrink)

Many different arguments have been put forward in order to assign the best place for a given element within Mendeleev's Table: its spectroscopy, its chemical activity, the crystalline structure of its solid state, etc. We here propose another criterion; the nature of the few body corrections to the pairwise additive energy. This argument is used here to address a question often brought forward by Eric Scerri in Foundations of Chemistry, namely the rightful place of helium; either above the column of (...) the alkaline earths (beryllium, etc.) or rather above the noble gas elements. (shrink)

Journal Name: Apeiron Issue: Ahead of print.

Over the turn of the 21st century, the use of data from large electronic corpora has changed research on Spanish historical syntax, spurring interest in long-range evolutions and the shape of the correspondent diachronic curves. However, general reflections on diffusion and the factors that drive and influence it are still pretty much lacking. In this paper, I reflect on the research possibilities laid open by the availability of such large masses of data, focusing particularly on new knowledge on syntactic change (...) brought about by the study of low-frequency phenomena and of recessive changes, as well as on the exploration of changes conditioned by dialect contact and textual traditions. I conclude with some remarks on the general typology of diffusion in syntactic change. (shrink)

El artículo presenta un análisis comparativo de los últimos parágrafos de la Vida de Pirrón de Diógenes Laercio (9.107-8) y de un capítulo del Adversus ethicos de Sexto Empírico ( _M_ 11.[5].141-67). Los resultados de este análisis harán plausible la hipótesis de una fuente común, reproducida parcialmente en DL, pero elaborada y refinada en Sexto. En ambos textos son centrales las nociones de fin y de elección. Se presentan las diferencias entre ambos textos entorno a la primera, y las tensiones (...) internas co munes que implica el tratamiento de la segunda. (shrink)

El artículo presenta un análisis comparativo de los últimos parágrafos de la Vida de Pirrón de Diógenes Laercio y de un capítulo del Adversus ethicos de Sexto Empírico. Los resultados de este análisis harán plausible la hipótesis de una fuente común, reproducida parcialmente en DL, pero elaborada y refinada en Sexto. En ambos textos son centrales las nociones de fin y de elección. Se presentan las diferencias entre ambos textos entorno a la primera, y las tensiones internas comunes que implica (...) el tratamiento de la segunda. The article provides a comparative analysis of the final paragraphs of Diogenes Laertius' Life of Pyrrho and a chapter from the Adversus ethicos by Sextus Empiricus. The results of the analysis make plausible the hypothesis regarding a common source, partially reproduced in DL, but elaborated on and refined in Sextus. The notions of end and choice are central in both texts. The paper presents the differences between the texts regarding the former and the common internal tensions entailed by treatment of the latter. (shrink)

Uno de los documentos de la Antigüedad que más atención susci-ta en los años recientes es el llamado Vidas de los filósofos de Diógenes Laercio. Una nueva edición del texto griego salió a la luz en 1999 y otra más está en preparación. A pesar de que durante mucho tiempo se consideró este tratado solamente como un nutrido testimonio doxográfico, y a la persona misma de Diógenes como un transmisor poco fiable de noticias, para la historia de la filosofía es (...) parte de la tradición material que necesariamente ha resultado indis-pensable en la construcción de nuestra visión de la filosofía griega hoy en día. El libro completo reporta los testimonios de al menos ochenta y cinco personalidades que hicieron parte del panorama intelectual de la antigua Grecia. De cada una de esas personalidades se dan tanto noticias sobre su vida como resúmenes de su actividad filosófica y ci-tas presuntamente literales de sus obras. (shrink)

This paper explores the political awakening of the Chilean people that began in October 2019. It puts forward an alternative reading of the people’s claim for a new constitution. The first section briefly describes the October outcry and provides some context with regards to the nature of the social movement at its root. The two following sections examine two periods in Chilean recent history, the Pinochet regime and the period that has come after its overturn, focusing on two elements: the (...) neoliberal model set up by the dictatorship and the Constitution of 1980, which was designed to block the people’s political agency for the purpose of protecting the model. The final section works with these two elements in order to provide an alternative scheme by which to examine Chile’s awakening, the central question being: what does the claim for a new constitution mean? And critical for these purposes: what constitution is being overturned? Pinochet’s political project distorted constitutional ideas in such a way that only by clarifying the conceptual horizon is it possible to visualize how the concept of constitution and its relationship with the idea of a constituent power of the people can be of help to understand Chile’s constitutional awakening. (shrink)

En este artículo se examinan, en primer lugar, los desarrollos aristotélicos acerca del fenómeno del psitacismo (la repetición inútil de palabras y expresiones), tal y como son expuestos en las Refutaciones sofísticas. Estos análisis son utilizados, en segundo lugar, para aclarar un argumento propuesto en Metafísica B de acuerdo con el cual el ser no es un género.

Violence has long been assumed to be an intrinsic trait of female prostitution. However, it has been mostly associated with the locale in which the activity is exercised, i.e. with working time and space. In this article, based on data gathered by direct observations, in-depth interviews and the compilation of so-called time-budgets, the authors demonstrate that violence is as pervasive and omnipresent a feature of prostitutes’ ostensibly private ‘off-duty’ time and space, though it takes on varied and distinct forms and (...) configurations, compared to violence in the workplace. (shrink)

1. Hume e a Magna Carta: em torno do círculo da justiça, Maria Isabel Limongi; 2. Hume e o problema da justificação da resistência ao governo, Stephanie Hamdan Zahreddine; 3 O surgimento dos costumes da sociedade comercial e as paixões do trabalho, Pedro Vianna da Costa e Faria; 4. O sentido da crença: suas funções epistêmicas e implicações para a teoria política de Hume, Lilian Piraine Laranja; 5. O Status do Fideísmo na Crítica de Hume à Religião Natural, Marília Côrtes (...) de Ferraz; 6. Da imaterialidade da alma: a desconstrução mais incisiva de Hume de um pressuposto metafísico, Marcos César Seneda; 7. A “irresistibilidade” e a “inevitabilidade” das crenças naturais e o caráter normativo da epistemologia de Hume, Claudiney José de Sousa; 8. Filosofia e vida comum na epistemologia de Hume, Marcos Fonseca Ribeiro Balieiro; 9. Hume e o relativismo moral, Flávio Zimmermann; 10. Hume e a vivacidade das crenças morais, André Luiz Olivier da Silva; 11. Virtudes sociais e refinamento na filosofia moral de David Hume, Andreh Sabino Ribeiro; 12. O movimento razão-crença na interpretação da teoria da motivação de Hume, Franco Nero Antunes Soares; 13. Sentimentos e Normatividade em David Hume segundo Annette Baier, Giovani Lunardi; 14. Simpatia e aprovação moral da justiça na filosofia de David Hume, Denize Carolina da Cunha & Nivaldo Machado; 15. Do eu como feixe de percepções ao eu das paixões: Hume e a identidade pessoal no Tratado, Susie Kovalczyk dos Santos; 16. Imaginação em Hobbes e Hume: cadeias mentais reguladas e princípios de associação, Andrea Cachel; 17. Hume e o princípio fundamental da filosofia moderna, Rafael Bittencourt Santos; 18. A conexão necessária entre Hume e Malebranche, Bruna Frascolla; 19. Realismo ontológico e antirrealismo epistemológico na problemática sobre o mundo externo em Hume, Leandro Hollanda; 20. Uma possível inversão kantiana da tese humeana da inércia da razão, Carlos Eduardo Moreno Pires; Nota sobre João Paulo Monteiro, Rolf Nelson Kuntz. (shrink)

Trata-se de uma introdução interpretativa ao primeiro livro filosófico publicado por Simone de Beauvoir, Pirro e Cinéias (1944), que inaugura, segundo ela, após a eclosão da Segunda Guerra Mundial, o período moral de sua carreira literária e seu interesse particular em atribuir um conteúdo material à moral existencialista – junto de um livro publicado posteriormente, Por uma moral da ambiguidade (1947). Destaca-se, portanto, que Beauvoir é a autora que vai superar as oposições que separavam a natureza da cultura, o corpo (...) do espírito, a liberdade da facticidade, a subjetividade da objetividade, o individual do coletivo, o particular do universal, de tal forma que sua alternativa será, no ensaio aqui estudado, pensar como as liberdades separadas entre si se reconhecem mutuamente para que o movimento ontológico de uma em direção à outra possibilite uma investigação do vínculo fundamental e indissociável entre os extremos mencionados. Com efeito, nossa conclusão é que Pirro e Cinéias anuncia duas das ideias centrais que esclarecem o período moral da literatura beauvoiriana, que é a individualidade de cada situação vivida, tal como as situações de suas personagens literárias, e o movimento das liberdades situadas em sua própria dimensão: a dimensão humana. (shrink)

Interpretative phenomenological analysis (IPA) is an idiographic approach to qualitative research. It is widely used in psychologically-informed studies which aim to understand the meaning and context of specific experiences. In this paper, we provide some background and introduction to the principles and processes underpinning IPA research. We extend this via a practical example, reporting on selected analyses from a study which explores the phenomenology and meaning of loneliness, through interviews conducted with a group of religious women. Through our observations on (...) the complex role of absence for loneliness, we show that IPA can be a powerful tool for exploring and understanding the meaning of salient experiences. We reflect on the significance of the results for advancing theories of loneliness; and on the capacity of the IPA approach to provide researchers with an important and useful phenomenological perspective, through its emphasis on context, and its commitment to integrating convergent and divergent claims. (shrink)

Com base na crítica que Hume faz ao argumento do desígnio, especialmente nas partes 10 e 11 dos Diálogos sobre a Religião Natural, meu objetivo neste artigo é, a partir de uma análise da relação entre a existência do mal no mundo e a suposta existência de uma divindade possuidora dos atributos tradicionais do teísmo, defender a tese segundo a qual o tratamento que Hume dá ao problema do mal corresponde, digamos assim, à cartada final – o último e decisivo (...) recurso que Philo personagem que articula essa crítica) aciona para mostrar que o argumento do desígnio não fornece bases suficientemente sólidas e consistentes para dar suporte à crença na existência de um Deus maximamente poderoso, justo e benevolente; e que, portanto, a existência do mal no mundo tem uma força argumentativa tal que a improbabilidade da existência de Deus é maior do que com base nos argumentos apresentados nas partes 2 a 8 dos Diálogos. Isso significa que eu tomo aqui o problema do mal como o maior problema para o teísta experimental – cuja argumentação pretende provar a existência de Deus a partir da observação dos fenômenos do mundo. (shrink)

Estudo comparado sobre o tratamento dado à reprodução humana assistida no direito do Brasil, Estados Unidos, Portugal, Espanha e Itália.

The Periodic Table has the column of the noble gas atoms (He, Ne, Ar, Kr, Xe, Rn) as one of its main pillars. Indeed the inert chemical nature of their closed shell structure is so striking that it is sometimes extended to all such structures. Is it true however that any closed shell, say a closed d-subshell will denote a lack of chemical activity? Take the noble metals for instance, so renowned for their catalytic capacity. Platinum has 10 electrons in (...) its valence shell which makes one of its excited states to be a closed 5d10–6s0 state. Surely this state would not be expected to be crucial to the catalytic activity of platinum, or would it? Or take palladium whose ground state is precisely the 4d10–5s0 state, should we expect that an isolated Pd atom at near zero-point temperature would attack a closed-shell hydrogen molecule efficiently? We shall here show that this is precisely the case; the closed-shell excited states of nickel and platinum are indeed crucial, through symmetry avoided crossings, for their reactivity. Other valuable catalysts as ruthenium depend on their excited states with maximal d-shell occupancy for their activity. The most notable confirmation of this new finding; that closed d-shells are vital to the catalytic activity of noble metals however, is the case of palladium whose closed-shell ground state is indeed capable of attacking hydrogen and hydrocarbon molecules even at temperatures well below 10 K as was predicted theoretically and immediately confirmed experimentally. (shrink)

El propósito de este texto es tematizar la precariedad con las herramientas de la filosofía política. Buscaremos equilibrar horizontes conceptuales con prácticas políticas para pensar la acción democrática en nuestro contexto. Nuestro argumento se compone de cuatro premisas. Primero, que elfalso dilema entre teoría y práctica nos permite explorar una relación de tensión creativa entre ambas para conceptualizar la precariedad. Segundo, que la construcción teórica de la precariedad responde tanto a ideas y conceptos como a instituciones y discursos que configuran (...) las vidas de quienes la experimentan. Tercero, que los distintos usos del concepto de precariedad permiten reconocer una fuente común de vulneración de derechos relacionada con la configuración del trabajo en el orden neoliberal. Cuarto, que relacionar la conceptualización de lo plebeyo con la de lo precario nos permite pensar prácticas democráticas renovadas. (shrink)

More organizations use AI in the hiring process than ever before, yet the perceived ethicality of such processes seems to be mixed. With such variation in our views of AI in hiring, we need to understand how these perceptions impact the organizations that use it. In two studies, we investigate how ethical perceptions of using AI in hiring are related to perceptions of organizational attractiveness and innovativeness. Our findings indicate that ethical perceptions of using AI in hiring are positively related (...) to perceptions of organizational attractiveness, both directly and indirectly via perceptions of organizational innovativeness, with variations depending on the type of hiring method used. For instance, we find that individuals who consider it ethical for organizations to use AI in ways often considered to be intrusive to privacy, such as analyzing social media content for traits and characteristics, view such organizations as both more innovative and attractive. Our findings trigger a timely discussion about the critical role of ethical perceptions of AI in hiring on organizational attractiveness and innovativeness. (shrink)

El presente trabajo investiga las tesis sobre el poder civil de Alonso de la Veracruz que buscan incorporar en la comunidad política española a los habitantes autóctonos del Nuevo Mundo, tesis que suelen relacionarse con F. de Vitoria y el tomismo español, y que últimamente son consideradas parte del republicanismo novohispano elaborado desde la periferia americana. Se busca demostrar que su propósito era aplicar una teoría de derechos naturales, sin que ello implique participación política de los indios americanos. Se analiza (...) la postura del fraile frente a la diversidad cultural y la guerra contra los indios. The paper explores Alonso de la Veracruz's theses on civil power, which sought to integrate the native inhabitants of the New World into the Spanish political community. These theses, which have usually been associated with F. de Vitoria and Spanish Thomism, have recently come to be considered part of a Novohispanic republicanism developed in the American periphery. The article seeks to show that the purpose of such theses was to apply a theory of natural rights that did not entail the political participation of the indigenous population, as well as to analyze Veracruz's position regarding cultural diversity and the war against the indigenous peoples. (shrink)