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)

Research on deviant organizational practices has demonstrated that normative and cognitive institutional forces contribute to making deviance acceptable. Data from a survey of 3,751 Chinese firms were applied to test the idea that a clearly articulated alternative identity is necessary if a firm is to resist the normalization of deviance. Widespread acceptance of delinquency in repaying loans was shown to make it more likely that a firm adopts that practice, but this normalization process is less likely for firms with a (...) stronger anti-deviance identity. (shrink)

We present three experiments using a novel problem in which participants update their estimates of propensities when faced with an uncertain new instance. We examine this using two different causal structures (common cause/common effect) and two different scenarios (agent‐based/mechanical). In the first, participants must update their estimate of the propensity for two warring nations to successfully explode missiles after being told of a new explosion on the border between both nations. In the second, participants must update their estimate of the (...) accuracy of two early warning tests for cancer when they produce conflicting reports about a patient. Across both experiments, we find two modal responses, representing around one‐third of participants each. In the first, “Categorical” response, participants update propensity estimates as if they were certain about the single event, for example, certain that one of the nations was responsible for the latest explosion, or certain about which of the two tests is correct. In the second, “No change” response, participants make no update to their propensity estimates at all. Across the three experiments, the theory is developed and tested that these two responses in fact have a single representation of the problem: because the actual outcome is binary (only one of the nations could have launched the missile; the patient either has cancer or not), these participants believe it is incorrect to update propensities in a graded manner. They therefore operate on a “certainty threshold” basis, whereby, if they are certain enough about the single event, they will make the “Categorical” response, and if they are below this threshold, they will make the “No change” response. Ramifications are considered for the “categorical” response in particular, as this approach produces a positive‐feedback dynamic similar to that seen in the belief polarization/confirmation bias literature. (shrink)

Marta Suria writes *Ella soy yo* as part of her response to the irruption of the memories of the sexual aggressions she had suffered since childhood. She is convinced that the way she narrates her experience will transform and liberate her. How is it at all possible that a certain kind of narrative may transform and li- berate us? In this paper, we will first describe the conception of the relationship between language and experience that lies behind this perplexity and, (...) secondly, we will sketch an alternative conception that will hopefully allow us to account for the transformative power of certain kinds of narratives. This alternative conception will hinge on the idea of expression and on the concept of aspect perception. For this purpose, we will firstly argue that language can be used not only to describe or evaluate our experience, but also to express it; we will, then, defend the view that linguistic or gestural expressions of our experiences not only announce or manifest them, but contribute to shaping and modulating them; finally, we will highlight the transformative, humanizing power of certain expressive uses of language. (shrink)

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)

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.

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.

ABSTRACT Doxxing is a form of online abuse where doxxers deliberately seek and publish their targets’ personal information without consent, often with malicious intent such as ruining their reputation. Despite its prevalence, doxxing has received little scholarly attention compared to other forms of online aggression, and almost no study has approached doxxing from a language and discourse perspective. This exploratory study analyzes 464 online forum posts and comments related to doxxing during the on-going pro-democracy movement in Hong Kong, addressing the (...) overarching question: In what ways is doxxing a discursive action? More specifically, how is doxxing realized intertextually? What are the discourse strategies that forum participants employ to legitimize doxxing? Informed by Critical Discourse Analysis, the analysis begins by illustrating doxxing as an intertextual and recontextualized social practice, focusing on a forum thread that discloses a police officer’s personal information. The core part of the paper discusses four key legitimation strategies of doxxing identified in the data, rationalization, definition, construction of negative-Other, and victimizing ‘Us’. The paper concludes by considering the role of doxxing in the Hong Kong social movement, and outlining some directions for future research. (shrink)

The aim of this paper is to describe and analyse the presence of Pascal’s thought in the work of the Spanish writer José Jiménez Lozano (1930-2020). In fact, it could be considered that this writer is almost a kind of Pascal come alive, especially in terms of understanding and experiencing Christianity, since, for both Pascal and Jiménez Lozano, the orientation of the human soul towards God is not only a part of the essence of man but also is his most (...) definitory anthropological constituent. (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)

What paths are taken by post-posi tiv ist so - cial the ory?. Be yond the three ba sic types of contemporarty the o ries stud ied in this pa per, the pre sup po si tions of which com bine struc ture and agent, the study of so ci ety in which ac knowl - edge ment of the prop er ties of dis tinct..

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)

This article explores the loss of social justice reported by individuals living in the environs of industrial wind turbines (IWTs). References indicate that some individuals residing in proximity to IWT facilities experience adverse health effects. These adverse health effects are severe enough that some families have abandoned their homes. Individuals report they welcomed IWTs into their community and the negative consequences were unexpected. Expressions of grief are exacerbated by the emotional and physical toll of individuals’ symptoms, loss of enjoyment of (...) homes and property, disturbed living conditions, financial loss, and the lack of society’s recognition of their situation. The author has investigated the reported loss of social justice through a review of literature, personal interviews with, and communications from, those reporting adverse health effects. The author’s intention is to create awareness that loss of social justice is being associated with IWT development. This loss of justice arises from a number of factors, including the lack of fair process, the loss of rights, and associated disempowerment. These societal themes require further investigation. Research by health professionals and social scientists is urgently needed to address the health and social impacts of IWTs operating near family homes. (shrink)

Research on environmental-decision making is usually based on utilitarian models, which imply that people's decisions are only influenced by the outcomes. This research provides evidence for values and moral positions that reflect nonconsequentialist rather than consequentialist views. In doing this, this article refers to “sacred values,” which are values that are seen as not-substitutable and nontradable. Two studies were designed to examine evidence for sacred values and their role on act versus omission choices within the environmental domain. The studies revealed (...) that sacred values were closely associated with preferences for actions, trade-off reluctance, deontological focus, and position of moral universalism. The results suggest that it is important to account for sacred values and nonconsequentialist views in environmental decision-making research. (shrink)

La extensión crítica pone énfasis en la prioridad de conseguir que las personas egresadas universitarios tengan conocimientos, capacidades, habilidades y destrezas técnicas y humanas para aportar en la resolución de problemáticas socioculturales de la manera más activa, justa, crítica y transformadora posible. A partir de una exploración cualitativa, tomando de base el enfoque de las capacidades y la extensión crítica, el estudio de caso de la Universidad Nacional de Rosario, Argentina, muestra que el estudiantado consigue poner el valor a las (...) capacidades logradas en su formación universitaria derivadas de las prácticas extensionistas. El estudiantado reportó el fortalecimiento de seis capacidades humanas y profesionales, alineadas con el desarrollo humano, que sirven para un profesionalismo que aspira a aportar a las transformaciones sociales más justas y democráticas, en favor de la defensa de la vida y del planeta. Este resultado apunta, por un lado, el potencial de la extensión crítica en la formación integral universitaria y, por otro, la necesidad de avanzar hacia una institucionalidad centrada en tales capacidades estudiantiles, como componentes estratégicos para una nueva agenda universitaria latinoamericana. (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)

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)

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)

RESUMEN: Hace treinta años la economía mundial, sobre todo en los países desarrollados, sufría, como ocurre ahora, una fuerte crisis económica. De aquella situación surgió un nuevo modelo de regulación de las economías capitalistas al que se llamó neoliberalismo. Desde entonces, con mayor o menor fuerza, ha estado presente en todos los países, aprovechando las condiciones de estos para repetir constantemente los mismos principios: la reducción del Estado, las ventajas del mercado, la autorregulación de éste, etc. Aunque sus premisas parezcan (...) simples o sencillas el neoliberalismo es un proyecto complejo y cambiante, cuya sustentabilidad política y económica se reinventa constantemente y cuya gobernanza y espacialidad es necesario observar y analizar si se quiere avanzar en alternativas viables. El neoliberalismo no vive apartado de proyectos alternativos sino que se mezcla con las alternativas, tiene una forma de gobernanza que muta, que cambia. Con este artículo pretendemos conocer algo más sobre las semejanzas y diferencias que esta ideología presenta según los países.ABSTRACT: Thirty years ago the world economy, especially the developed countries, suffered, as it is the case now, a severe economic crisis. That situation arose a new regulatory model of capitalist economies is called neo-liberalism. Since then, with more or less force, has been present in all countries, taking advantage of these conditions to constantly repeat the same principles: the reduction of the State, the advantages of the market and self-regulation of this, etc. Although its premises seem simple or simple neo-liberalism is a complex and changing project whose political and economic sustainability constantly reinvents itself and whose governance and spatiality is necessary to observe and analyze whether you want to advance in viable alternatives. Neo-liberalism does not live away from alternative projects but is mixed with the alternatives, has a form of governance that mutates, which changes. With this communication we seek to know something more about the similarities and differences that this ideology presents of the countries. PALABRAS CLAVE: liberalismo, keynesianismo, neoliberalismo, ultraliberalismo.KEYWORDS: liberalism, keynesianism, neoliberalism, ultraliberalism. (shrink)

Hunting ducks with a firearm has become increasingly contested in industrialized and urbanized contemporary societies. In southern New Zealand, an area that maintains strong connections to rural life ways, duck shooting is still a very popular activity. However, even duck shooters living in this region are increasingly finding that they must justify an activity their grandparents practiced without compunction. This paper considers ethical discourses associated with the killing of ducks, particularly the ways in which people who shoot ducks construct the (...) act of killing as an activity that can be ethically justified. As this paper will show, duck hunters assert that they have a more realistic and appropriate view of nature and animal life cycles than the average antihunter who might criticize them. New Zealand duck hunters also embed their hunting activities within a discourse of wetland conservation, arguing that they do far more to preserve and develop wetlands than do non-hunters. This paper concludes that duck hunters' understandings of nature are intrinsic to the ethical discourses that underpin duck hunting activities in New Zealand. (shrink)

Bird kill rate and disruption of habitat has been reported when industrial wind turbines are introduced into migratory bird paths or other environments. While the literature could be more complete regarding the documentation of negative effects on birds and bird habitats during the planning, construction, and operation of wind power projects, there is sufficient evidence to raise concerns. Authoritative and mandatory vigilance monitoring and long-term surveillance over the life of the industrial wind facility are lacking. By the time the documentation (...) of the rate of bird kills, including that of endangered species is available in an environs of an industrial wind turbine facility, the damage may be irreversible. This article briefly explores the negative environmental impacts of the siting of industrial wind turbines and associated infrastructure, including transformer stations and transmission lines, in proximity to migratory bird corridors, wetlands, and nesting grounds. Research is required prior to proceeding with further industrial wind development in these environs. The authors propose that there is sufficient scientific evidence to require invoking the precautionary principle and halting further development until these risks are resolved. (shrink)

Industrial wind turbines (IWTs) are a new source of community noise to which relatively few people have yet been exposed. IWTs are being erected at a rapid pace in proximity to human habitation. Some people report experiencing adverse health effects as a result of living in the environs of IWTs. In order to address public concerns and assess the plausibility of reported adverse health effects, a number of literature reviews have been commissioned by various organizations. This article explores some of (...) the recent literature reviews on IWTs and adverse health effects. It considers the completeness, accuracy, and objectivity of their contents and conclusions. While some of the literature reviews provide a balanced assessment and draw reasonable scientific conclusions, others should not be relied on to make informed decisions. The article concludes that human health research is required to develop authoritative guidelines for the siting of IWTs in order to protect the health and welfare of exposed individuals. (shrink)

Industrial wind turbines (IWTs) are being installed at a fast pace globally. Researchers, medical practitioners, and media have reported adverse health effects resulting from living in the environs of IWTs. While there have been some anecdotal reports from technicians and other workers who work in the environs of IWTs, little is known about the occupational health sector. The purpose of this case study is to raise awareness about the potential for adverse health effects occurring among workers. The authors propose that (...) there is a need for research regarding occupational worker exposure relating to IWTs. (shrink)

Wind turbines produce sound that is capable of disturbing local residents and is reported to cause annoyance, sleep disturbance, and other health-related impacts. An acoustical study was conducted to investigate the presence of infrasonic and low-frequency noise emissions from wind turbines located in Falmouth, Massachusetts, USA. During the study, the investigating acousticians experienced adverse health effects consistent with those reported by some Falmouth residents. The authors conclude that wind turbine acoustic energy was found to be greater than or uniquely distinguishable (...) from the ambient background levels and capable of exceeding human detection thresholds. The authors emphasize the need for epidemiological and laboratory research by health professionals and acousticians concerned with public health and well-being to develop effective and precautionary setback distances for industrial wind turbines that protect residents from wind turbine sound. (shrink)

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.

This article proposes that education, according to Antonio Gramsci, is a political act. To support our thesis, first we review the concepts hegemony, organic intellectual and historic bloc. In a second level, we use those concepts to understand education. In a third level we present a proposal for a functional political and ethical approach of education in current society. La tesis del artículo es que la educación en el pensamiento de Antonio Gramsci constituye un acto político. Para dar sustento a (...) nuestra tesis, en una primera aproximación hacemos una revisión de los conceptos de hegemonía, intelectual orgánico y bloque histórico. En un segundo nivel, nos aproximamos a la utilidad de dichos conceptos para una comprensión del fenómeno educativo. En un tercer y final nivel presentamos al lector una primera exploración de la función política y ética de la educación en la sociedad actual. (shrink)

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)