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)
This paper studies a distinction that was proposed in previous works between total and partial adjectives. In pairs of adjectives such as safe–dangerous, clean–dirty and healthy–sick, the first (“total”) adjective describes lack of danger, dirt, malady, etc., while the second (“partial”) adjective describes the existence of such properties. It is shown that the semantics of adjective phrases with modifiers such as almost, slightly, and completely is sensitive to whether the adjective is total or partial. The interpretation of such modified constructions (...) is accounted for using a novel scale structure for total and partial adjectives. It is proposed that the standard value of a total adjective is always fixed as the lower bound of the corresponding partial adjective. By contrast, the standard value of partial adjectives can take any point on the partial scale. The effects of this theoretical distinction on the behavior of modified constructions are studied in detail, and their ramifications for the semantic theory of adjectives are discussed. Some other phenomena are surveyed that show evidence for total and partial adjectival constructions with various comparatives and exceptive phrases. (shrink)
Drawing on stakeholder theory and the evolutionary approach to institutions, this paper investigates the channels through which corporate social responsibility (CSR) is developed in post-communist economies by focusing on the employee background factors that shape the employees' expectations with regard to corporate socially responsible behaviour. We identify three channels through which exogenous and endogenous CSR are developed: employees with work experience in multinational enterprises (MNEs) (leading to exogenous CSR), employees with CSR knowledge (leading to exogenous CSR) and employees with experience (...) of the socialist system (leading to endogenous CSR). Furthermore, we argue that the interactions between these channels lead to hybrid CSR in transition economies. We use a questionnaire-based survey with employees of domestic and MNEs in Romania and we conduct regression analysis. We find that employees with work experience in MNEs act as channels for exogenous CSR, while employees with experience of the socialist system act as channels for endogenous CSR. Furthermore, employees with experience of the socialist system and CSR knowledge or work experience in an MNE act as channels for hybrid CSR in transition economies. Based on our results, we put forward implications for theory, managers and policy makers. (shrink)
Data are lacking with regard to participants' perspectives on return of genetic research results to relatives, including after the participant's death. This paper reports descriptive results from 3,630 survey respondents: 464 participants in a pancreatic cancer biobank, 1,439 family registry participants, and 1,727 healthy individuals. Our findings indicate that most participants would feel obligated to share their results with blood relatives while alive and would want results to be shared with relatives after their death.
The perception of sensory effects generated by one’s own actions is typically attenuated compared to the same effects generated externally. However, it is unclear whether this specifically relates to self-generation. Recent studies showed that sensory attenuation mainly relies on action preparation, not actual action execution. Hence, an attenuation of sensory effects generated by another person might occur if these actions can be anticipated and thus be prepared for.Here, we compared the perceived loudness of sounds generated by one’s own actions and (...) actions of another person that either could or could not be anticipated. We found an attenuation of the perceived loudness for self- as compared to other-generated sounds. This difference was independent of whether the sound-eliciting actions of the other person could be anticipated or not. Thus, sensory attenuation seems to be specifically tied to self-generation instead of being a secondary effect of agent-independent preparation for an upcoming action. (shrink)
Gene editing techniques, such as CRISPR, are being heralded as powerful new tools for delivering agricultural products and foods with a variety of beneficial traits quickly, easily, and cheaply. Proponents are concerned, however, about whether the public will accept the new technology and that excessive regulatory oversight could limit the technology’s potential. In this paper, we draw on the sociotechnical imaginaries literature to examine how proponents are imagining the potential benefits and risks of gene editing technologies within agriculture. We derive (...) our data from a content analysis of public comments submitted to the Food and Drug Administration’s 2017 docket titled “Genome Editing in New Plant Varieties Used for Food.” Our sample frame consists of 26 comments representing 30 agriculture and biotech companies, organizations, and trade associations. Our findings reveal three key sociotechnical imaginaries, including that gene editing technologies in agriculture: are not GMO but instead equivalent to traditional plant breeding; have the potential to usher in a new Green Revolution; and could facilitate the democratization of agricultural biotechnologies. We argue that forming and projecting these collective interpretations of the potential of gene editing technologies for crops and foods plays an important role in efforts by proponents to influence regulatory oversight, modes of governance, and build public acceptance. This research contributes to calls by science and technology studies scholars to investigate emergent concerns and imaginaries for novel technoscientific advances to help inform upstream models of public engagement and governance decisions. (shrink)
Abstract: This paper analyzes some influential ideas in virtue ethics. Alasdair MacIntyre, in his work After Virtue, and Elizabeth Anscombe, in his controversial essay “Modern Moral Philosophy”, brought fresh ideas into moral philosophy of their time changing views on contemporary morality. They strongly influenced moral philosophers who then followed their ideas. The two philosophers criticized contemporary moral philosophies such as emotivism, utilitarianism, deontology. Elizabeth Anscombe criticized also the use of the concepts of duty and moral obligation in the absence of (...) God as the context God had no place. For solving the quests of modern morality, both MacIntyre and Anscombe proposed that the only solution was the returning to ancient Aristotelian virtues. (shrink)
Carmen 4.2 is one of the most commented upon of the odes of Horace. It is indeed a complex poem. To summarize roughly: addressing the young poet Iullus Antonius, Horace presents the dangers of emulating Pindar, offering what seems like a lengthy description as well as an approximation of Pindar's own poetic style . Not as a doomed Icarus imitating the grand Pindaric swan, but in his own preferred mode, like a bee on the banks of Tibur, Horace will (...) continue to produce his own highly refined poems on a small scale . Iullus Antonius, on the other hand, will sing of Augustus’ triumph maiore plectro . Modestly, Horace himself will be content to join in with the popular chants for Augustus’ triumphal return as one happy civilian among the crowd . Iullus Antonius will moreover offer a grand sacrifice of ten bulls and as many cows on that occasion, whereas Horace promises a single bull-calf that he is saving especially for the purpose . I will try to offer a new interpretation of these last two strophes by pointing out an unnoticed allusion to a Hellenistic subtext. (shrink)
Given the crucial role of the mass media in influencing public discourse, this study examines the discourses around climate change within the Brazilian press, covering the time period of 2003–2013. Survey evidence has shown that Brazilians’ degree of concern about climate change is higher than almost anywhere else, with nine out of 10 Brazilians considering climate change a serious problem. The primary purpose of this study is to investigate how the press engendered Brazilians’ striking level of climate change concern, with (...) special attention to how the discourse developed over time. To this end, I undertake a corpus-assisted discourse analysis to examine the most dominant linguistic patterns in the discourse, presenting evidence on an unprecedented scale and with considerable depth. The corpus consists of 19,686 newspaper texts published by 12 Brazilian broadsheet papers. The results are interpreted in the light of available opinion polls on the public’s perception of climate change as well as Brazil’s national context and environmental governance. (shrink)
In this article, I use ethnographic and historical evidence to consider marriage as a particular locus of what Maria Lugones has called “the colonial/modern gender system.” By bringing specific research on marriage among the matrilineal Asante of Kumasi, Ghana, together with a consideration of global ideals of marriage and gender, I argue that marriage and the family are key sites through which the subjugation of women in Africa can be understood, but that this requires local and historical contextualization. To do (...) this, I trace the emergence and current local expression of “companionate marriage,” an ideal of marriage that is associated with romantic love and personal choice, and that is often seen as a gender-progressive marriage ideal. In Kumasi, “companionate” ideals began to emerge during the colonial period, not as an empowering force, but in complicated interactions with other gendered changes that limited wives' claims to husbands' reciprocal support and isolated women from their matrilineal kin. Today, customary marriage is often considered harmful to women and distinct from other forms of marriage; however, I show that such assumptions impose categorial differences where none may exist, and occlude the complexities of women's lives and struggles. (shrink)
Esta obra propone una interpretación alternativa de las relaciones entre la ética y la tragedia en Aristóteles sobre la base de una revisión que parte de la Poética, pero no ha quedado encerrada en ella, considerando otros textos ...
Lawrence, Carmen Why should we protect our heritage? In the broadest sense our heritage is what we inherit; it's what we value of that inheritance and what we decide to keep and protect for future generations. Heritage is both global enough to encompass our shock at the destruction of the Buddhas of Bamiyan in Afghanistan and as local as our own sepia-tinted family photographs. Everything which our predecessors have bequeathed, both tangible and intangible, may be called heritage - landscapes, (...) structures, objects, traditions, stories and language. (shrink)
Dienes & Perner argue that the explicit representation of an individual to which a property is attributed requires explicit representation of the attributed property. The reasons for this conclusion are similar to the reasons why another of their conclusions may be considered suspect: A property may be explicit without an explicit representation of an individual or the predication of the property to an individual. We question the latter conclusion and draw connections to neurophysiological and cognitive evidence.
We argue that while the proposed memory model by Bastin et al. can explain familiarity-based memory judgements through the interaction of a core representation system and an attribution system, recollection-based memory judgements are not based on non-mnemonic signals being attributed to memory.
We compare two approaches given to the parallelogram law as a fundamental notion in eighteenth century mechanics. The authors we study are Kant and d’Alembert and we use the context created by Newton’s Principia as our point of departure.En este artículo comparamos dos caminos seguidos en el tratamiento de la ley del paralelogramo como noción fundamental en la mecánica del siglo XVIII. Los autores que estudiamos son Kant y d’Alembert y utilizamos el contexto creado por los Principia de Newton como (...) nuestro punto de partida. (shrink)
The discovery of the noble gases and their incorporation into the periodic system are examined in this paper. A chronology of experimental reports on argon and helium and the properties relevant to their nature and position in the periodic system is presented. Proposals on the nature of argon and helium that appeared in the aftermath of their discovery are examined in light of the various empirical and theoretical considerations that supported and contradicted them. ``The piece that would not fit'' refers (...) not only to argon, the element that at first seemed not to fit into the periodic system, but also to the piece or pieces of evidence that various researchers and observers were prepared to discard or discount in coming to terms with the newly discovered gases. (shrink)
Sea cual sea el resultado final de las elecciones, lo cierto es que ha habido una pequeña revolución, a pesar de todas las ironías implicadas, en la política americana. Hillary Clinton no ha alcanzado la nominación pero ahora una mujer republicana, a su manera puede representar el cumplimiento de un sueño feminista, demostrando que no hay barreras al éxito de una mujer llegada del rincón más conservador de EEUU, el estado de Alaska.
En lugar de pensar que la iglesia tiene una misión, se piensa que la misión tiene una iglesia para llevarla a cabo. La tensión entre las dos percepciones no está, por supuesto, solucionada, pero al menos existe el diálogo y la aceptación por parte de todos de ese sentido de misión como parte de la esencia de la iglesia.
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