I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women9s Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial (...) protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. (shrink)

Since time immemorial, the phenomenon of leadership and its understanding has attracted the attention of the business world because of its important role in human groups. Nevertheless, for years efforts to understand this concept have only been centred on people in leadership roles, thus overlooking an important aspect in its understanding: the necessary moral dimension which is implicit in the relationship between leader and follower. As an illustrative example of the importance of considering good morality in leadership, an empirical study (...) is conducted in which a good performance of the "leader-follower" relationship is reflected when individuals perceive ethical leadership in higher hierarchical managerial levels. To be precise, findings of this study demonstrate that follower job response is improved through an ethics trickle-down partial effect from the Top Manager to the immediate supervisor, and also reveal both key aspects and managerial level on which the practice of ethical leadership should rest upon to have a stronger effect on the follower positive job response. Practical implications of these findings and directions for future research are finally presented. (shrink)

Phenomenology and the Kyoto School implement an interaction among cultures1 that is not limited to illustrating Western philosophy wxith exotic similes. Insofar as my position is concerned, I will start out with phenomenology in order to study Nishida's work, trying on the one hand to understand the meaning that he gives to nothingness in relation to the Merleau-Pontian concept of creux in order, on the other hand, to enlarge reason and philosophy.To achieve this, I shall establish a comparison of the (...) two thinkers that will help to shed light on their conceptions, while at the same time demonstrating the efficacy of thinking the unthoughts or negativities indicating a... (shrink)

Persons infected with the Human Immunodeficiency Virus often experience intermittent life-threatening infections, a progressive decrease in cognitive abilities, and a loss of capacity to communicate their wishes to their family and medical care providers. Accordingly, AIDS patients are among those most likely to benefit from the increased availability of legally recognized forms of advance care planning. Although the three countries examined in this article differ greatly in the prevalence of HIV infection, the legal status of advance directives, and in the (...) attitudes toward their use, a collection of case studies is used to demonstrate that an ability to address the specific needs, values and goals of individual patients is promoted by the availability of a variety of options for implementing advance directives or health care proxies. The conclusion of the analysis is that the best option in a specific context will depend upon differences in individual values and medical objectives of the sort discussed in the case studies. Das mit der HIV-Infektion verbundene Krankheitsbild ist durch wechselnde lebensbedrohliche Infektionen und den fortschreitenden Verfall kognitiver Fähigkeiten gekennzeichnet. Es führt zudem häufig zum Verlust der Möglichkeit, Behandlungswünsche gegenüber Ärzten und Angehörigen zu äußern. Deshalb gehören besonders AIDS-Patienten zu denjenigen, die von rechtlich anerkannten vorsorglichen Patientenverfügungen profitieren werden.In diesem Artikel werden drei Länder betrachtet, die sich hinsichtlich der Häufigkeit des Auftretens der HIV-Infektion sowie des rechtlichen Status von und der Einstellung zu Patientenverfügungen erheblich unterscheiden. Fallstudien belegen allerdings, daß nicht allein die kulturellen und sozialen Bedingungen für die jeweils beste Form der Patientenverfügung ausschlaggebend sind. Voraussetzung für die Möglichkeit, den Bedingungen, Wert- und Zielvorstellungen des individuellen Patienten zu entsprechen, ist auf jeden Fall die Verfügbarkeit unterschiedlicher Formen von Patienten- und Betreuungsverfügungen. Auch innerhalb eines Kulturkreises müssen daher verschiedene Formen vorsorglicher Willensäußerungen des Patienten rechtlich anerkannt werden. Welche Art von Verfügung jeweils die beste Option darstellt, ist dabei abhängig von medizinischen Bedingungen und persönlichen Wertvorstellungen, wie sie in den Fallstudien diskutiert werden. (shrink)

El presente texto se inscribe dentro de la temática dirigida a la investigación sobre la violencia intrafamiliar. Tiene como objetivo sistematizar aspectos históricos y teóricos inherentes al estudio del maltrato infantil y sus consecuencias en el ámbito social y familiar para su detección y tratamiento en el nivel de atención primaria de los servicios de salud en Cuba. Mediante una revisión bibliográfica se logró concretar un análisis documental de materiales y textos en soporte digital e impreso que condujo a los (...) acercamientos teórico e histórico del fenómeno en el ámbito internacional y nacional, para su conceptualización, la determinación de su tipología y el establecimiento de sus consecuencias; elementos imprescindibles del saber profesional del futuro egresado de las ciencias médicas, en función de su desempeño en los diferentes niveles de atención de salud, en especial, la atención primaria. The text falls within the research on intrafamiliar violence subject matter. Its objective is to systematize historical and theoretical aspects inherent to the study of child abuse and its consequences within the social and domestic scopes for its detection and treatment in the Cuban primary health care services. By means of a bibliographic review, a documentary analysis of electronic and printed form materials and texts was summarized. It led to theoretical and historical approaches to the phenomenon within the national and international scopes for its conceptualization, the establishment of its typology and consequences. They are essential elements of the professional knowledge of future medical sciences graduates towards their performance in different health care levels, especially in primary health care. (shrink)

El objeto de profundizar en el análisis de la calidad de vida en adultos mayores, la incidencia de la familia, valores y brechas intergeneracionales, en la ciudad de Torreón Coahuila, México, con analisis cuantitativo aplicado a 230 sujetos, 5 ejes y con variables, validado con Alpha de Cronbach de 0.88 resultado del análisis: la importancia de que adultos cuente con la información en lo referente a: su proceso de envejecimiento, proceso salud-enfermedad y la intervención de políticas públicas gubernamentales, entorno familiar (...) y creencias son determinante en su acompañamiento su fusión demandando una aplicación oportuna de políticas publicas y sociales. (shrink)

Este trabajo intenta analizar la concepción, naturaleza jurídica y garantía de los derechos económicos, sociales y culturales, en América Latina, así como las condiciones y medidas que pueden contribuir a su efectividad. Presenta tambien una propuesta de indicadores que pueden utilizarse en la supervision de la efectividad de esos derechos y de la proteccion que ellos han alcanzado, proporcionando información sobre la situactón latinoamericana y caribeña actual.

The purpose of this study was to examine student perceptions of teaching behavior. Additionally the aim was to examine if teacher characteristics (educational level, gender, and teaching experience) could explain differences in student perceptions of their teachers. Teaching behavior was studied from the research on teaching and teacher effectiveness perspective. Secondary students (N = 7,114), taught by 410 teachers in Spain, participated in the study. Survey data were analyzed using non-parametric tests, Kruskal-Wallis, U Mann-Whitney with Bonferroni correction, and the analysis (...) of effect sizes. Furthermore, a regression model was applied. Results showed that teaching behavior was perceived as sufficient to good, depending on the teaching behavior domain. Results indicated interesting differences between lower secondary education, upper secondary education and vocational education and training teachers. The effect size values (rU statistic) ranged between 0.43 and 0.63, highlighting the significant effect of teachers’ teaching experience on the six teaching skills domains: learning climate, efficient classroom management, clarity of instruction, activating teaching, differentiation, and teaching learning strategies. Those teachers with less teaching experience were the ones who showed higher scores. Findings from the regression model showed that educational level had a significant predictive effect on the six teaching skills domains, mainly for male teachers. However, in several domains female teachers were perceived by students to outperform their male counterparts. (shrink)

Normal 0 false false false PT-BR JA X-NONE Este ensaio é constituído por reflexões a respeito de alteridade na educação, defendendo a necessidade de olhar o Outro como fonte de aprendizagem, visando o desenvolvimento de relações dialógicas e alteritárias. De início, analisa-se a construção da subjetividade moderna cuja centralidade é o sujeito autônomo e racional que pensa e define as relações a partir de princípios pretensamente universais, os quais muitas vezes procuram assimilar o Outro em si mesmo. A sustentação teórica (...) do texto é o pensamento de Emmanuel Levinas, e daí emerge a proposta de pensar o Outro em sua diferença não para objetivá-lo, mas acolhendo-o em sua realidade concreta. Assim, a presente proposição defende processos de mediação educativa, onde os sujeitos, pela presença do rosto do Outro, deixam-se despertar para a responsabilidade e abertura à exterioridade. (shrink)

In eukaryotic cells the nucleus and its contents are separated from the cytoplasm by the nuclear envelope. Macromolecules, as well as smaller molecules and ions, can cross the nuclear envelope through the nuclear pore complex. Molecules greater than approx. 60 kDa and containing a nuclear localization signal are actively transported across the nuclear membranes, but there has been little evidence for regulatory mechanisms for smaller molecules and ions. Recently, diffusion across the nuclear envelope has been observed to be regulated by (...) nuclear cisternal Ca2+ concentrations. Following depletion of Ca2+ from the nuclear store by inositol 1,4,5‐trisphosphate or Ca2+ chelators, a fluorescent 10 kDa marker molecule was no longer able to enter the nucleus. Distinct conformational states of the nuclear pore complexes depended on the Ca2+ filling state of the nuclear envelope, supporting the assumption that a switch in the conformation of the nuclear pore complex may control the transport of intermediate‐sized molecules across the nuclear envelope. Thus nuclear Ca2+ stores may regulate the conformational state of the nuclear pore complex, and thereby passive diffusion of molecules between the cytosol and the nucleoplasm. The physiological significance of this finding is currently unknown. (shrink)

The complexity and emotional/psychological responses to the environmental challenges of the 21st century has led to the coining and development of new words and concepts that, for some people, better describe how they are personally grappling with anthropogenic ecosystem damage and climate breakdown. This paper identifies some of the more commonly used environmental neologisms within scholarly literature and evaluates their usefulness and contradictions for those influenced by the virtue ethics promoted by the ancient Stoics and the Catholic Church. We find (...) that environmental neologisms, when framed by these philosophical and/or theological ideas, offer an alternative and, ultimately, helpful means to contemplate the nature of what might be considered an environmental crisis and how best we might address, or at least, mitigate it, as conscientious spiritual human beings. (shrink)

En esta obra se analizan las ideas estéticas más relevantes de tres filósofos contemporáneos, H. Marcuse, M. Merleau-Ponty y H-G. Gadamer, articuladas en torno a la productiva interrelación arte y filosofía y, todavía más concretamente, en torno a la preocupación por el tipo de razón y la búsqueda racional de la libertad que predomina en el ámbito artístico.

Resumen: La idea dialéctico-hermenéutica de experiencia, entendida como Erfahrung, reivindica el lugar de esta en el lenguaje, sosteniendo que no es necesario desterrarla al territorio de lo a-racional y prelingüístico. Tanto Gadamer como también Agamben, a pesar de sus diferencias, han mostrado la incontestable vinculación entre experiencia y lenguaje: este es el lugar de la verdad de la experiencia, aunque esta no sea científica. Una experiencia no puede ser tal si no puede ser transmitida. La actual experiencia de crisis se (...) muestra, también, como una crisis de experiencia. Los seres humanos tienen su arraigo en un mundo significativo, que es el de la experiencia, el de experiencias verdaderas. Y verdaderas son las que se pueden convertir en una gran o pequeña historia.: The dialectic-hermeneutic idea of experience, understood as Erfahrung, vindicates the place it has in language, maintaining that it is not necessary to banish it from the realm of the a-rational and pre-linguistic. Both Gadamer and Agamben, despite their differences, have shown the undeniable link between experience and language: this is the place of the truth of experience, even if this truth is not scientific. An experience cannot be considered as such if it cannot be transmitted. The current experience of crisis also reveals itself as a crisis of experience. Human beings are rooted in a world of significance, the world of experience, of true experiences. And those that are true can become either a great or short story. (shrink)

This paper aims at providing some insights into the philosophical tools that may help solve the huge problems of social justice. For that purpose, I focus on the concept of responsibility, since it could be a suitable catalyst for debate. This paper argues that we must necessarily develop an enhanced notion of responsibility and commit to it both at a social and institutional level. First, I will introduce the relation between ethics and politics—necessarily rather than contingently intertwined. I will elaborate (...) on the concept of poliethics coined by the Spanish philosopher Francisco Fernández Buey. Second, I will outline certain changes undergone in recent years to the understanding of the concept of responsibility in the field of ethics and politics. Finally, I will argue that a significant extension of the notion of responsibility is still necessary if it is to play a relevant role in the contemporary world. I will therefore contend that there are sufficient reasons why our societies should do the moral stretch exercises suggested by Günther Anders. For that purpose, I suggest ten tenets that could serve as a basis for this poliethics of enhanced responsibility and for a collective reflection on this issue. (shrink)