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)

The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial (...) obligations, specifically, access to care after research and access to information after research. The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature. I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations. I defend the view that paragraph 34 of ‘Post-trial provisions’ is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous ‘fair benefit’ language. However, I criticize the disappearance of ‘access to other appropriate care’ present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research. (shrink)

The paper Post-Trial Acces To Treatment (PTA) offers an insight into current corporate policies and corporate best practices relating to the provision of PTA in low and middle income countries based on company sources. In these countries there is a greater appeal for pharmaceutical companies to take responsibility for providing PTA. However, the practice of providing PTA is the exception rather than the rule.

Background: In response to the pandemic caused by COVID-19, World Health Organization (WHO), together with International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), developed research protocols facilitating global collaboration and accelerating the understanding of the disease, to identify the potential symptoms and persistent sequelae in infected individuals, which can be used in different areas of health, that is, in primary care, at a hospital or outpatient level, both public and private. Objective: To describe the International Severe Acute Respiratory and (...) Emerging Infection Consortium (ISARIC) protocol as a new global collaborative platform for global clinical trials targeting post-COVID-19 patients. Methods: The standardized forms were developed from the COVID-19 Clinical Characterization Protocol (PCC) by the ISARIC/WHO working group composed of specialist researchers with experience in clinical research in different areas of medicine and public health, especially outbreaks and infectious diseases. Conclusion: It is expected that the creation of a database composed of different populations from all over the world will help in the characterization of risk factors, in the best form of clinical intervention and in the best prevention strategies for physical, neurological and psychosocial sequelae in the medium and long term in post-COVID-19 patients. (shrink)

The paper suggests that Samuel Taylor Coleridge’s arguments against sympathy after the French Revolution, Walter Benjamin’s claims against empathy following the traumatic shock of Modernity and the First World War, and Hannah Arendt’s critical take on compassion. after the Holocaust are similar responses to singular historical crises. Reconsidering Arendt’s On Revolution (1963) and its evocation of Hermann Melville’s novella Billy Budd (1891), I show first that the novella bears the traces of an essay by Samuel Taylor Coleridge, “The Appeal to (...) Law” (1809). Then, drawing on Walter Benjamin’s writings on trauma in Illuminations (1968, edited by Arendt), I discuss the political importance Arendt attaches to the proper way of telling a story, at a time when “the communicability of experience is decreasing” (Benjamin, Illuminations, 86). Through the analysis of Benjamin’s “The Storyteller” and Arendt’s “heartless” report on the Eichmann trial (1963), I equally show that, according to Arendt, testimonies must be narrated, or rather performed, in a dispassionate, dry, and compact manner so that they can be historically and politically relevant. (shrink)

ABSTRACT Many recent articles argue that participants who seroconvert during HIV prevention trials deserve treatment when they develop AIDS, and there is a general consensus that the participants in HIV/aids treatment trials should have continuing post‐trial access. As a result, the primary concern of many ethicists and activists has shifted from justifying an obligation to treat trial participants, to working out mechanisms through which treatment could be provided. In this paper I argue that this shift frequently conceals (...) an important assumption: that if there is an obligation to supply treatment, then any party who could provide it may be prevailed upon to discharge the obligation. This assumption is false. The reasons why trial participants should get ART affect who has the duty to provide it. We should not burden governments with the obligations of sponsors, nor researchers with the obligations of the international community. And we should not deprive a group of treatment because their need is less salient than that of research participants. Insisting otherwise may lead to people being wrongfully deprived of access to antiretrovirals. (shrink)

El problema de la transición de los participantes desde una investigación hacia la atención de la salud apropiada es un problema global. La publicación de una nueva versión de la Declaración de Helsinki es una excelente oportunidad para repensar este problema. Según mi interpretación, la Declaración de Helsinki 2013 introduce dos tipos diferentes de obligaciones posinvestigación, a saber, (1) obligaciones de acceso a atención de la salud y (2) obligaciones de acceso a información. Los beneficiarios pretendidos de estas obligaciones son (...) los participantes individuales de estudios de investigación. Y la Declaración identifica a los patrocinadores, investigadores y gobiernos de los países anfitriones como los principales agentes responsables de cumplir con las obligaciones posinvestigación. Para justificar esta interpretación de los tipos, agentes y beneficiarios de las obligaciones posinvestigación, presento primero una clasificación tentativa de las obligaciones posinvestigación. Luego hago una breve reconstrucción conceptual de las formulaciones de las obligaciones posinvestigación en las versiones anteriores de la Declaración y reviso las principales críticas. Finalmente presento un análisis crítico de la nueva formulación de las obligaciones posinvestigación basándome en la discusión de las secciones anteriores. [ABSTRACT] The problem of transitioning research participants when the study is concluded to the appropriate health care is a global problem. The publication of a new version of the Declaration of Helsinki and its public discussion is a great opportunity to rethink this problem. According to my interpretation, the Declaration of Helsinki 2013 identifies two different types of post-trial obligations, namely, (1) obligations of access to health care and (2) the obligations of access to information. The intended beneficiaries of these obligations are individual participants of research studies. And the Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of the types, agents and beneficiaries of post-trial obligations, I first introduce a tentative classification of post-trial obligations. Then I make a brief conceptual reconstruction of formulations of post-trial obligations in earlier versions of the Declaration and revise the main critiques. Finally I advance a critical analysis of the new formulation of post-trial obligations based on the discussion in the previous sections. (shrink)

El objetivo del presente trabajo es analizar la nueva formulación del principio de acceso posinvestigación en la más reciente (2008) revisión de la Declaración de Helsinki. Se identifican los artículos relevantes de la Declaración y se presentan dos interpretaciones posibles del principio de acceso posinvestigación: una interpretación robusta y otra permisiva, inspiradas cada una por modelos de justicia distintos. Luego, se hace una evaluación crítica de dichas interpretaciones y se intenta avanzar argumentos en contra de la interpretación permisiva. [The objective (...) of this study is to critically analyze the new formulation of the principle of post-trial access in the most recent (2008) revision of the Helsinki Declaration. The relevant articles of the declaration are identified and two possible interpretations of the principle of post-trial access are set out; one robust and one permissive, inspired by different models of distributive justice. A critical evaluation of both interpretations is presented and arguments against the permissive one advanced.]. (shrink)

Todos los días se prueban nuevos psicofármacos, tratamientos para el VIH/SIDA o el cáncer, entre otras enfermedades. Algunos de esos tratamientos son lo suficientemente exitosos como para cronificar enfermedades antes consideradas mortales, como los antirretrovirales para el VIH/SIDA o el imatinib para la leucemia mieloide a principios del 2000. No obstante, antes de que puedan ser comercializados o estar disponibles en los sistemas de salud pública, deben pasar por una serie de rigurosas pruebas de calidad, seguridad y eficacia. Estas pruebas (...) implican el testeo de las drogas en animales y su estudio en seres humanos, sanos o enfermos. Estrictas normas de buenas prácticas científicas y éticas regulan todo el proceso de las investigaciones biomédicas. El problema de mi tesis se centra en el momento de la finalización de los estudios en seres humanos. Alguien podría preguntarse qué pasa con las personas si se benefician clínicamente del tratamiento experimental durante el estudio cuando este finaliza. La interrupción abrupta de un tratamiento beneficioso podría poner en peligro la salud de los sujetos. Y en el caso de sujetos de investigación afectados por enfermedades crónicas, es probable que deban continuar con el tratamiento beneficioso u otra atención adecuada por el resto de sus vidas. Un sujeto de investigación estadounidense sin seguro de salud que participó en un estudio de largo plazo de diabetes resume estas preocupaciones: "de repente cortan la cuerda, y uno está solo por su cuenta ... O conseguís trescientos o cuatrocientos dólares por mes para seguir con esto o simplemente seguís adelante y morís". Este tipo de casos me llevaron a preguntar si existe alguna obligación moral de proveer el tratamiento beneficioso a un sujeto de investigación que no puede pagárselo. Muchas personas podrían pensar que interrumpir el tratamiento beneficioso al sujeto de investigación que padece de diabetes y no tiene seguro para cubrir un tratamiento es incorrecto, porque nadie debería morir de una enfermedad o dedicar todos los recursos disponibles para sobrevivir, especialmente cuando se contribuyó a encontrar una cura o a obtener la evidencia científica necesaria para desarrollar un mejor tratamiento que el existente. Otras personas podrían pensar que lo correcto es ofrecer el tratamiento a un "precio justo", y si la persona no puede pagar por la continuidad de tratamiento es su responsabilidad. Mi intuición es que una sociedad democrática justa tiene una obligación moral de establecer un sistema de continuidad de tratamiento beneficioso para los sujetos de investigación. En esta tesis intento justificar filosóficamente esta última intuición básica utilizando el marco teórico de la teoría de la justicia de Rawls. Elijo utilizar la teoría rawlsiana, porque esta teoría me permite ubicar los problemas morales con respecto a la continuidad de tratamiento beneficioso en su contexto social adecuado y en el contexto de la búsqueda general de una sociedad más justa. En particular, la encuentro especialmente adecuada para explicar fenómenos complejos de responsabilidad social como los que creo que subyacen en el problema de la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Como mostraré más adelante, es imposible tener en cuenta los aspectos morales de la continuidad de tratamiento beneficioso aislada de la sociedad en la que se realizan los estudios con seres humanos. En el capítulo 1 presento una introducción general al tema de la ética de la investigación y al problema de la continuidad de tratamiento beneficioso. En el capítulo 2 intento determinar el campo de estudio de la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Para eso, mi estrategia es la siguiente. Primero, busco identificar los casos de estudios clínicos donde se daría la obligación de continuidad beneficiosa hacia los sujetos de investigación. Segundo, presento el problema de la justificación moral de la obligación de continuidad y la necesidad de discutir las justificaciones basadas en la idea de justicia como reciprocidad. Para esto, en la sección 2, identifico la obligación de continuidad de tratamiento a través de una selección de sus casos paradigmáticos en la literatura. Comienzo con el caso de los estudios clínicos con antirretrovirales llevados a cabo en Sudáfrica en personas con VIH/SIDA. Luego, introduzco el concepto teórico de sistema de continuidad de tratamiento beneficioso. Este concepto me permite evaluar y comparar teóricamente cómo diferentes sociedades hacen frente al problema de proveer la continuidad de tratamiento beneficioso a los sujetos de investigación. Por último, rastreo los casos ejemplares de obligación de continuidad de tratamiento beneficioso hacia los sujetos en países desarrollados, con énfasis especial en los Estados Unidos. En la sección 3, analizo algunos problemas de confusión o ambigüedad más importantes en torno a la obligación. Primero, analizo el nombre de la obligación. Luego, trato de distinguir la obligación de continuidad de tratamiento hacia los sujetos de investigación de la obligación de disponibilidad razonable, una confusión muy común en la literatura de la ética de la investigación. Finalmente, me detengo a analizar una posible ambigüedad en el concepto de "tratamiento beneficioso" y utilizo algunos de los casos paradigmáticos identificados para argumentar a favor de mi interpretación. Atacado el primer problema, en la sección 4 y 5 me vuelco a relevar el problema de la justificación moral de la obligación de continuidad. En la sección 4, reconstruyo lo que llamo la "versión simple" del concepto de obligación a partir de la discusión sobre las fuentes de la obligación de continuidad de tratamiento beneficioso. Luego, planteo la necesidad de investigar las justificaciones basadas en la idea de justicia como reciprocidad debido a las ambigüedades y la falta de un marco teórico claro dentro del campo de la ética de la investigación en seres humanos. Finalmente, en la sección 5, introduzco algunas distinciones clásicas con el fin de complejizar el marco teórico de las obligaciones, el cual será utilizado en la discusión de los próximos dos capítulos. En el capítulo 3 discuto la justificación de la obligación de continuidad de tratamiento que da el modelo económico de Alan Wertheimer. En la sección 1 del capítulo, debido a lo específico del tema y lo poco conocido del autor, introduzco a la persona y el contexto institucional de su obra. En la sección 2 del capítulo, distingo tres interpretaciones del concepto de justicia como reciprocidad e intento mostrar que Wertheimer utiliza una interpretación caracterizada por el uso mutuo y el intercambio de beneficios, a la cual llamo "reciprocidad de mercado". En la sección 3, presento el marco teórico del modelo económico. La pregunta fundamental de Wertheimer es la siguiente: ¿tienen los investigadores o patrocinadores una obligación supercontractual de proporcionar la continuidad de tratamiento u otros beneficios a los sujetos de investigación? Según el autor, el consenso en ética de la investigación responde de manera afirmativa a esta pregunta y como fundamento de esta obligación se encontraría lo que Wertheimer llama "el principio de interacción". Analizo este principio y presento las críticas que hace Wertheimer al mismo. En la sección 4, presento la respuesta a la pregunta fundamental que da Wertheimer mediante su "argumento estratégico". En la sección 5 analizo la solución dada por Wertheimer e intento explicar algunos de los supuestos principales del modelo, a saber, (i) la lógica del argumento estratégico, (ii) la fuerza moral de los conceptos de Pareto y (iii) el compromiso del modelo económico con la restricción de la información. Por último, en la sección 6 presento mis críticas al modelo económico. En el capítulo 4 presento el modelo de reciprocidad democrática, inspirado en la teoría de la justicia de Rawls. Este modelo se presenta como un marco teórico y una interpretación de la justicia como reciprocidad alternativos al modelo económico presentado en el capítulo anterior. En la sección 2 del presente capítulo, explicito los problemas del marco teórico relacionados con el concepto de justicia como reciprocidad que subyacen a la discusión sobre la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Para esto, me centro en tres puntos: (i) la relación del principio de justicia como reciprocidad y el concepto de obligación; (ii) el problema del alcance del principio de reciprocidad, y (iii) la relación entre el principio de reciprocidad y el concepto de equidad, o lo que llamo "el problema de la medida de la reciprocidad". En la sección 3, defino con mayor claridad el enfoque rawlsiano de la justicia distributiva y expongo una crítica a los argumentos antirrawlsianos esgrimidos por los defensores del modelo económico que afirman que los principios de justicia política de Rawls no se aplican a los individuos. Si mi respuesta a los defensores del modelo económico es correcta, los principios de justicia política se aplican a los individuos de manera indirecta, mediante la asignación de obligaciones posicionales por parte de la estructura básica de instituciones de una sociedad democrática, y permiten garantizar igual justicia a todos los miembros de la sociedad. En la sección 4, presento mi propuesta original de cómo entender la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Esta sería una obligación posicional perfecta correlativa con el derecho a la salud en sociedades democráticas justas o moderadamente injustas. En la sección 5, muestro de manera detallada el mecanismo apropiado para extender los principios de justicia política al caso de la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Con este objetivo, introduzco la idea de secuencia en cuatro etapas, que permite evaluar y diseñar nuevos esquemas institucionales para dar contenido a la obligación de continuidad de tratamiento. Y presento los principios de obligaciones y deberes individuales, que cierran el sistema rawlsiano brindando razones morales a los individuos para extender los esquemas institucionales justos a nuevas situaciones, reformar los existentes y cumplir con las obligaciones posicionales asignadas por estos nuevos esquemas. Por último, en la sección 6, discuto las objeciones más importantes al modelo de justificación de reciprocidad democrática. Por último, en la conclusión general, hago un intento de aplicación del marco teórico del modelo de reciprocidad democrática al análisis de los sistemas de continuidad de tratamiento para países como Argentina o Brasil y presento las líneas más importantes para la investigación futura. (shrink)

Care after research is for participants after they have finished the study. Often it is NHS-provided healthcare for the medical condition that the study addresses. Sometimes it includes the study intervention, whether funded and supplied by the study sponsor, NHS or other party. The NHS has the primary responsibility for care after research. However, researchers are responsible at least for explaining and justifying what will happen to participants once they have finished. RECs are responsible for considering the arrangements. There (...) are ethical and practical issues, in particular when participants may wish to continue on the study intervention after the study. There are also various guidelines and legislation. This document presents a framework of questions to help NHS RECs and their applicants. Information on this document’s development is here. (shrink)

When it comes to how to hold people responsible for wrongdoing, much of the African philosophical tradition focuses on reconciliation as a final aim. This essay expounds an interpretation of reconciliation meant to have broad appeal, and then draws out its implications for responsibility in respect to three matters. First, when it comes to criminal justice, prizing reconciliation entails that offenders should be held responsible to “clean up their own mess,” i.e., to reform their characters and compensate victims in (...) ways they find burdensome, an approach to punishment that differs from deterrence and desert theories. Second, regarding civil justice, reconciliation means that holding responsible to compensate wrongful harm means improving victims’ quality of life in ways they accept, which contrasts with a common prescription to put victims in the condition they would have been in had the wrong not occurred. Third, reconciliation can involve putting on trial more than just the direct offender, for instance family members who had been able to influence his behavior and were allied with him. The chapter provides reason to take the reconciliatory approaches seriously that will be found prima facie attractive by those from a variety of backgrounds. (shrink)

Memory Detection Tests (MDTs) are a general class of psychophysiological tests that can be used to determine whether someone remembers a particular fact or datum. The P300 MDT is a type of MDT that relies on a presumed correlation between the presence of a detectable neural signal (the P300 “brainwave”) in a test subject, and the recognition of those facts in the subject’s mind. As such, the P300 MDT belongs to a class of brain-based forensic technologies which have proved popular (...) and controversial in recent years. With such tests increasingly being proffered for use in the courtroom — to either support or call into question testimony — it would behoove the legal system to have some systematic framework for ensuring that they are used responsibly. In this paper, I defend one such framework for ensuring that this is the case: the legitimacy enhancing test. According to this test, it is appropriate to make use of technologies such as the P300 MDT whenever doing so would (probably) enhance the legitimacy of the trial. I argue that this test addresses tensions between scientific and legal norms of evidence, and exhibits a number of additional virtues including unification, simplicity and flexibility. Although the test is defended by considering the example of the P300 MDT, its significance is much broader than that. If it has the virtues I claim for it, it should provide a general framework for the responsible use of technologies, and the responsible innovation of social epistemic systems. (shrink)

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

研究早期中国哲学的学者均普遍认为，缺乏作者和思想学 派的资料，对以哲学为本的研究非常不利。就着这个观点，本文提出异议: 汉学研究所提供的文献、文学、语言、历史的知识，可融贯于早期中国哲学 的研究，并产生良好的影响。蒋韬在 2016 年提出了“汉学挑战”的论述。就此，本文论证，汉学正好 提供一个机会，结合不同的研究方法及角度，从而更有效地处理具体的哲 学议题。我以自己对“命”的研究为例，解释如何以多个文本为基础，梳理 哲学问题，做“没有作者的哲学”，并显示:融贯汉学研究所提供的各种方 法、知识、研究工具，不仅无损哲学研究，更为其注入新气象。我采取了“后学科”的研究角度:受到前学科文化(例如早期中国文 化)的启发，“后学科”的角度在提问时，往往从整体出发，不囿于各个学科 的既定模式和分类;并开辟新路向，容纳创意，追寻意义，以产生可行的新 联系。 Some scholars of early Chinese philosophy see the knowledge provided by Sinology as a challenge to the development of sound philosophical enquiry. What Sinology tells us about the historical context and the textual, material, and intellectual culture of the period is considered detrimental for engaging in philosophical research, reason why these scholars believe that Chinese philosophy must separate itself from Sinology. I argue that Sinology does not offer (...) a challenge but an opportunity to engage with a multitude of approaches and methods to more efficiently address philosophical problems and questions. I offer my own research as an example of how to integrate the knowledge and analytical tools offered by Sinology in a philosophical study of early China. Focusing on the most crucial Sinological challenge--the challenge to the notions of “book” and “author"--I show that using the methods and knowledge provided by other disciplines does not jeopardize but, much to the contrary, invigorates and revitalizes philosophical research. My perspective is post-disciplinary: inspired by pre-disciplinary cultures such as early China, post-disciplinarity engages inquiry holistically, suspending the patterns and categories established by discrete disciplines, forging new paths for creativity and the search of meaning, and allowing new viable connections to emerge. (shrink)

We present a novel model of individual people, online posts, and media platforms to explain the online spread of epistemically toxic content such as fake news and suggest possible responses. We argue that a combination of technical features, such as the algorithmically curated feed structure, and social features, such as the absence of stable social-epistemic norms of posting and sharing in social media, is largely responsible for the unchecked spread of epistemically toxic content online. Sharing constitutes a distinctive communicative act, (...) governed by a dedicated norm and motivated to a large extent by social identity maintenance. But confusion about this norm and its lack of inherent epistemic checks lead readers to misunderstand posts, attribute excess or insufficient credibility to posts, and allow posters to evade epistemic accountability—all contributing to the spread of epistemically toxic content online. This spread can be effectively addressed if people and platforms add significantly more context to shared posts and platforms nudge people to develop and follow recognized epistemic norms of posting and sharing. (shrink)

‘Post-truth’ has become a buzzword for numerous current crises: the fragmentation of the media landscape, the ongoing debate about ‘fake news’, the loss of trust in science, etc. Although these crises take place in society, it is claimed that the roots of post-truth can be traced back to the history of philosophy. Occasionally, it is asserted that Karl Popper’s critical rationalism gave rise to post-truth: His rejection of verificationism has limited truth claims in the realm of science. (...) Given the absence of infallible evidence and certainty, critical rationalism calls for challenging scientific authority. I argue that post-truth is compatible with critical rationalism from an epistemological point of view, considering that both positions are critical of certainty. However, in critical rationalism, fallibilism, responsibility, and the idea of criticism are combined, and in this respect, it offers a possible way to overcome the problems that are associated with post-truth. This treatment of the problems of post-truth results from the recognition of moral responsibility to take action on the basis of a hypothesis that remains open to revision. (shrink)

The claim that we live in a post-truth era has led to a significant body of work across different disciplines exploring the phenomenon. Many have sought to investigate the role of fake news in bringing about the post-truth era. While this work is important, the narrow focus on this issue runs the risk of giving the impression that it is mainly new forms of media that are to blame for the post-truth phenomenon. In this paper, we call (...) attention to the ways in which journalistic practices in traditional forms of media also play an important role in contributing to a post-truth environment. We will do so by focusing on one particular practice common in news journalism. False balance involves presenting two sides of a debate as more equal than is justified by the evidence. We will argue that although false balance does not constitute fake news, it does contribute to an environment in which truth is devalued. By obscuring what counts as evidence and who qualifies as an authority, false balance legitimizes post-truth attitudes. We finish by outlining the virtues that journalists should develop in order to guard against false balance. While fake news is made more likely when journalists possess the vices of dishonesty, prejudice or corruption, we argue that focusing too much on guarding against these vices may actually make false balance more likely. In order to be responsible gatekeepers and to avoid false balance, journalists must also develop the virtues of wisdom, vigilance, courage, care and justice. (shrink)

Este artículo considera el problema de justicia en la investigación biomédica en países en desarrollo. En particular se hace foco en la discusión de si el requisito de poner a disposición toda intervención probada efectiva puede ser considerado como una obligación post investigación de los patrocinadores hacia la comunidad anfitriona. Primero, se discuten las concepciones de la Comisión Nacional de Asesoramiento sobre Bioética (NBAC) de los Estados Unidos y de las guías éticas internacionales sobre la obligación post investigación (...) hacia la comunidad. Luego, se examinan las interpretaciones del modelo de disponibilidad razonable y el modelo de beneficios justos sobre la condición de acceso a los beneficios post investigación. Por último, presento y critico el argumento del carácter contraproducente de la obligación post investigación que afirma que la obligación post investigación limita el desarrollo de la investigación y empeora la situación de las poblaciones de los países en desarrollo. [ABSTRACT] This article refers to the problem of justice in biomedical research in developing countries and in particular it focus in the discussion of whether the requirement of making available any effective intervention could be consider a post-trial obligation of the sponsor towards the host community. First, the National Advisory Bioethics Commission’s (NBAC) conception and the international guidelines’ conception of post-trial obligations towards the community are discussed. Second, the interpretation of reasonable availability model and the fair benefits model of the condition of access to post trial benefits are examined. Finally, I present and criticize the moral counterproductive argument which affirms that post trial obligations towards the community prevent new drug research and make population in developing countries worse off. (shrink)

Post-mortem reproduction is a complex and contested matter attracting attention from a diverse group of scholars and resulting in various responses from a range of countries. Vietnam has been reluctant to deal directly with this matter and has, accordingly, permitted post-mortem reproduction implicitly. First, by analysing Vietnam’s post-mortem reproduction cases, this paper reflects on the manner in which Vietnamese authorities have handled each case in the context of the contemporary legal framework, and it reveals the moral questions (...) arising therefrom. The article then offers an account of Vietnamese social norms as an explanation for the tendency to conduct post-mortem reproduction. In arguing that a deeper and more thorough examination of the moral and ethical reasoning is required, the paper advocates in favour of supportive post-mortem reproduction regulation. In doing so, the paper seeks to reconcile the Vietnamese legal framework and post-mortem reproduction experiences of other countries. The article concludes that Vietnam and countries sharing the similar cultural traits should permit post-mortem reproduction explicitly. This would require full engagement with the ethical and legal issues arising, and careful promulgation of regulations and guidelines based on comparative experiences of a range of countries in handling this matter. (shrink)

[This download includes the table of contents and chapter 1.] -/- When we praise, blame, punish, or reward people for their actions, we are holding them responsible for what they have done. Common sense tells us that what makes human beings responsible has to do with their minds and, in particular, the relationship between their minds and their actions. Yet the empirical connection is not necessarily obvious. The “guilty mind” is a core concept of criminal law, but if a defendant (...) on trial for murder were found to have serious brain damage, which brain parts or processes would have to be damaged for him to be considered not responsible, or less responsible, for the crime? The authors argue that evidence from neuroscience and the other cognitive sciences can illuminate the nature of responsibility and agency. They go on to offer a novel and comprehensive neuroscientific theory of human responsibility. (shrink)

Translation from Spanish to English of ANMAT’s procedure for import of post-trial access provisions. This is a regulatory mechanisim to comply with post-trial provisions requirement in Declaration of Helsinki, paragraph 34. The translation it is based on a selection of the text of ANMAT’s Provision 12792/2016. -/- .

In this essay, I consider Sally Haslanger’s social constructivist account of race and propose a modification to the nature of hierarchy specified. According to Haslanger, race will cease to exist post-hierarchy, given that she builds in a requirement of synchronic hierarchy for the existence of race. While Haslanger maintains that racial identity would linger beyond hierarchical treatment in the form of ethnicity, I will suggest this fails to provide adequate conceptual justice for the cultures and aesthetics which emerged out (...) of past oppression. In response, I propose a modification which would allow us to recognize the possibility of post-hierarchical races. (shrink)

This paper examines recent forms of post-identity thought within contemporary gender theory, specifically the works of Rosi Braidotti, Elizabeth Grosz and Bobby Noble. Despite the many insights that these theories offer, I argue that they suffer from what Lois McNay has labelled ‘social weightlessness’ insofar as their models of subjectivity and agency are disconnected from the everyday realities of social subjects. I identify two ways in which this social weightlessness is manifested in radical gender theories that endorse a (...) class='Hi'>post-identity politics: they overlook the social and political importance to many individuals of establishing stable, coherent identities; they are unable to offer a satisfactory account of agency. I suggest that these issues arise, at least in part, from the anti-recognition stance adopted by such radical gender theorists. I argue that by incorporating a properly nuanced model of recognition back into their theories they can imbue their accounts with a properly grounded model of the subject that is responsive to the inequalities and oppressions that infuse the particular concrete contexts in which we experience and live out our identities. (shrink)

Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the (...) 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. (shrink)

As a grand narrative of progress, the utopian project of modernity is primarily concerned with notions of rationalism, universalism, and the development of a metalanguage. The triumph of the Moderate Enlightenment has seen logics of domination, accumulation and individualism incorporated into the project of modernity, with these logics giving rise to globalised capitalism as the metalanguage of modernity and neoliberal economics as the grand narrative of rational progress. The project of modernity is all but complete, requiring only the formality of (...) an end. However, rather than utopia, the foreseeable endpoint of modernity is environmental collapse, with neoliberal economics also serving as a grand narrative of environmental destruction. As an anti-modern response, postmodernism has been a triumphant failure. While there is much to be gained from the postmodern critique of modernity, its incredulity towards metanarratives has left it incapable of forming an adequate response to modernity, especially in regards to action on climate change. Postmodernism is better characterized as a crisis located within modernity itself and it will be argued that rather than the pursuit of the modern or the post-modern, we need to re-imagine ourselves as proto- historical to overcome the impasse of late-capitalism. (shrink)

This Open Access book shows how value sensitive design (VSD), responsible innovation, and comprehensive engineering can guide the rapid development of technological responses to the COVID-19 crisis. Responding to the ethical challenges of data-driven technologies and other tools requires thinking about values in the context of a pandemic as well as in a post-COVID world. Instilling values must be prioritized from the beginning, not only in the emergency response to the pandemic, but in how to proceed with new societal (...) precedents materializing, new norms of health surveillance, and new public health requirements. -/- The contributors with expertise in VSD bridge the gap between ethical acceptability and social acceptance. By addressing ethical acceptability and societal acceptance together, VSD guides COVID-technologies in a way that strengthens their ability to fight the virus, and outlines pathways for the resolution of moral dilemmas. This volume provides diachronic reflections on the crisis response to address long-term moral consequences in light of the post-pandemic future. Both contact-tracing apps and immunity passports must work in a multi-system environment, and will be required to succeed alongside institutions, incentive structures, regulatory bodies, and current legislation. This text appeals to students, researchers and importantly, professionals in the field. (shrink)

After the 9/11 attacks the U.S. administration went beyond emergency response towards imperialism, but cloaked its agenda in the rhetoric of fighting ‘terrorists’ and ‘terrorism.’ After distinguishing between emergency thinking and emergency planning, I question the administration’s “war on terrorism” rhetoric in three stages. First, upon examining the post-9/11 antiterrorism discourse I find that it splits into two agendas: domestic, protect our infrastructure; and foreign, select military targets. Second, I review approaches to emergency planning already in place. Third, after (...) reviewing what philosophers have said about emergencies, I recommend they turn their attention to the biases inherent in and misleading uses of antiterrorist terminology. (shrink)

The burgeoning literature on jus post bellum has repeatedly reaffirmed three positions that strike me as deeply implausible: that in the aftermath of wars, compensation should be a priority; that we should likewise prioritize punishing political leaders and war criminals even in the absence of legitimate multilateral institutions; and that when states justifiably launch armed humanitarian interventions, they become responsible for reconstructing the states into which they have intervened – the so called “Pottery Barn” dictum, “You break it, you (...) own it.” Against these common positions, this chapter argues that compensation should be subordinate to reconstruction, with resources going where they are most needed and can do the most good, rather than to the most aggrieved. Just punishment, meanwhile, presupposes just multilateral institutions – the victor cannot be trusted to mete out punishment fairly. And just interveners, who have already taken on such a heavy burden, are entitled to expect the international community to contribute to reconstruction after they have made the first and vital steps. After presenting each of these objections in greater depth, the chapter proceeds to draw some tentative inferences from the threads running through each, and suggest that they illustrate a distinctive flaw in the way in which jus post bellum is addressed by many just war theorists, who not only see the war as the grounds of post bellum duties, but also take it to specify their content: Specifically, they take the rights violations with which wars are imbued to be the basis for post-war action, but take the content of post-war duties to be focused on rectifying those rights violations, rather than the more forward-looking goal of establishing a lasting peace. This backward-looking orientation unduly confines these theorists to making attributions of fault, to a limited palette of normative concepts, and to a focus on the belligerents rather than the international community as a whole. Undoubtedly warfare creates a distinctive normative relationship between belligerent states (though we must question how much of this devolves to the citizens of those states). War does generate grounds for post-war duties – but there are other grounds for those duties too, moreover the grounds should not determine the content. It of course matters that the citizens of two states harmed one another in violation of their rights. But when the war is done, peacebuilding should be the priority, not raking over the wrongs of both sides. Sections 2–4 present the objections, Section 5 offers the tentative analysis and proposes a shift in focus toward an ethics of peacebuilding, and Section 6 concludes. (shrink)

Just days after the election of Donald Trump to the presidency of the United States, specific passages from American philosopher Richard Rorty’s 1998 book were shared thousands of times on social media. Both and wrote about Rorty’s prophecy and its apparent realization, as within the haze that followed this unexpected victory, Rorty seemed to offer a presciently trenchant analysis of what led to the rise of “strong man” Trump. However, in this paper, Forstenzer points to Rorty’s own potential intellectual (...) class='Hi'>responsibility in the unfolding crisis of liberal democracy. -/- This paper seeks to elucidate the relationship between Rorty’s liberal ironism and contemporary post-truth politics. While the paper ultimately concludes that Rorty is not causally responsible and thus not complicit with the rise of post-truth politics, it contends that Rorty’s philosophical project bears some intellectual responsibility for the onset of post-truth politics insofar as it took a complacent attitude towards the dangers associated with over-affirming the contingency of our epistemic practices in public debate. In the last instance, this paper argues that Rorty’s complacency is a pragmatic failure and thus cuts to the heart of his pragmatism. (shrink)

The discipline of knowledge translation (KT) emerged as a way of systematically understanding and addressing the challenges of applying health and medical research in practice. In light of ongoing and emerging critique of KT from the medical humanities and social sciences disciplines, KT researchers have become increasingly aware of the complexity of the translational process, particularly the significance of culture, tradition and values in how scientific evidence is understood and received, and thus increasingly receptive to pluralistic notions of knowledge. Hence, (...) there is now an emerging view of KT as a highly complex, dynamic, and integrated sociological phenomenon, which neither assumes nor creates knowledge hierarchies and neither prescribes nor privileges scientific evidence. Such a view, however, does not guarantee that scientific evidence will be applied in practice and thus poses a significant dilemma for KT regarding its status as a scientific and practice-oriented discipline, particularly within the current sociopolitical climate. Therefore, in response to the ongoing and emerging critique of KT, we argue that KT must provide scope for relevant scientific evidence to occupy an appropriate position of epistemic primacy in public discourse. Such a view is not intended to uphold the privileged status of science nor affirm the “scientific logos” per se. It is proffered as a counterbalance to powerful social, cultural, political and market forces that are able to challenge scientific evidence and promote disinformation to the detriment of democratic outcomes and the public good. (shrink)

Moral anti-theodicists have posed a consequentialist argument against the theodical enterprise: that theodicies lead to harmful consequences in reality and that this should be sufficient reason to motivate abandoning the practise of theodicising altogether. In this paper, I examine variants of this argument and discuss several prominent responses from theodicists, including the separation thesis. I argue that while these responses are effective in resisting the global conclusion by the anti-theodicist, it still leaves the theodical enterprise vulnerable to a weaker version (...) of the consequentialist critique. In response, I develop an account of ‘theodicies-of-embrace-protest’ which is able to preserve the meaningful strides made in traditional theodicies while taking seriously the criticisms of the moral anti-theodicists. I suggest that sceptical theism fits this bill. (shrink)

The article presents the advantages and limitations of adaptive clinical trials for assessing the effectiveness of medical interventions and specifies the conditions that contributed to their development and implementation in clinical practice. I advance two arguments by discussing different cases of adaptive trials. The normative argument is that responsible adaptation should be taken seriously as a new way of doing clinical research insofar as a valid justification, sufficient understanding, and adequate operational conditions are provided. The second argument is historical. The (...) development of adaptive trials can be related to lessons learned from research in cases of urgency and to the decades-long efforts to end the productivity crisis of pharmaceutical research, which led to the emergence of translational, personalized, and, recently, precision medicine movements. (shrink)

Can matter, things, nonhuman organisms, technologies, tools and machines, biota or institutions be seen as creative? How does such creativity reposition the visionary activities of humans? This article is an elaboration of such questions as well as an attempt at a partial response. It was written as an editorial for the special issue of the Digital Creativity journal that interrogates the conception of Post-Anthropocentric Creativity. However, the text below is a rather unconventional editorial. It does not attempt to provide (...) an overview of the issue’s theme but, instead, samples it via a particular example. The idea of the issue was to think about post-anthropocentricism by considering (1) agents, recipients and processes of creativity alongside with its (2) purpose, value, ethics and politics. This article addresses the first subtheme by puzzling at the paradoxes of “field learning” and picks at the second by considering the texture of “automated beauty”. Both of these parts use chess for an example. The narrative on chess is intermitted by a section “on creativity” that attempts to contextualize the case-based discussion in the wider context and to consider motivations and implications. (shrink)

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a novel antiviral medicine aimed (...) at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of Molnupiravir through the large-scale PANORAMIC randomised control trial. By analysing the ways in which the authorisation and clinical use of Molnupiravir complicate standard approaches to clinical equipoise, standard of care, and participant consent in the PANORAMIC randomised control trial we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

Proposals for allocating scarce lifesaving resources in the face of the Covid-19 pandemic have aligned in some ways and conflicted in others. This paper attempts a kind of priority setting in addressing these conflicts. In the first part, we identify points on which we do not believe that reasonable people should differ—even if they do. These are (i) the inadequacy of traditional clinical ethics to address priority-setting in a pandemic; (ii) the relevance of saving lives; (iii) the flaws of first-come, (...) first-served allocation; (iv) the relevance of post-episode survival; (v) the difference between age and other factors that affect life-expectancy; and (vi) the need to avoid quality-of-life judgments. In the second part, we lay out some positions on which reasonable people can and do differ. These include (i) conflicts between maximizing benefits and priority to the worst off; (ii) role-based priority; and (iii) whether patients’ existing lifesaving resources should be subject to redistribution. (shrink)

The story of eternity is not as simple as a secularization narrative implies. Instead it follows something like the trajectory of reversal in Kant’s practical proof for the existence of god. In that proof, god emerges not as an object of theoretical investigation, but as a postulate required by our practical engagement with the world; so, similarly, the eternal is not just secularized out of existence, but becomes understood as an entailment of, and somehow imbricated in, the conditions of our (...) practical existence. -/- The sections that follow discuss some of those central figures in modern European philosophy whose views prominently feature some consideration of eternity. I start with Kant in section I. Kant’s critique of speculative theology is well-known, and this hostility would appear to make it unlikely that the eternal, with all its theological baggage, would feature prominently in Kant’s critical philosophy. But in fact Kant’s transcendental idealism endorses no fewer than three different concepts of the eternal, including what turns out to be the most historically influential idea: that practical reason involves a kind of eternal, non-temporal action. Kant shifts this notion of a non-temporal act from its original theological context of god’s actus purus to a practical context, setting the stage for Schelling’s and Kierkegaard’s later development of this theme. Before detailing this trajectory however, section II is devoted to Hegel, the philosopher whose radical historicism is perhaps more than any other thinker responsible for making “the nineteenth century preeminently the historical century.”4 Hegel is not fertile soil for the concept of the eternal, but his historicism does turn out, at a crucial moment in the philosophy of nature, to presuppose a certain conception of eternity as an eternal present. Perhaps more importantly for the further development of eternity in nineteenth century thought however is that both Schelling and Kierkegaard situate their views of the eternal in the context of a collective rejection of Hegel. Section III discusses Schelling, who returns to Kant’s conception of non-temporal choice, seeing human capacities for free eternal self-creation as rivaling god’s. Such powers are required, Schelling argues, to resist the sublimation of the individual human person into the blankness of the Absolute. Section IV briefly consider Schopenhauer’s view that the in-itself of everything is an endlessly striving will. Section V concerns Kierkegaard who is strongly committed to the eternal, and indeed criticizes Hegel for compromising his conception of the eternal by thinking it temporally; but he is obsessed by the paradoxical question of our practical “access” to the eternal within a particular temporal moment: the decisive moment, imbued with significance that can turn life around and create a new person, pushing Schelling’s concerns even further. The remaining, shorter sections, present briefer accounts of more recent figures who make important use of some conception of the eternal: Nietzsche’s eternal return (section VI), Agamben’s (1942-) theory of sovereignty (section VII) and finally Alain Badiou’s unapologetic attempt to resuscitate eternity as the condition of revolutionary political change (Section VIII). I end with a concluding meditation (Section IX). (shrink)

The global pandemic caused by the spread of a novel coronavirus in early 2020 did more than transform the first one-and-a-quarter academic year that fell within its duration. It also transformed higher learning in its research and pedagogy. Like many misfortunes, COVID-19 has brought opportunity for growth and change. No doubt, there are many success stories of philosophers rising to the challenges of our time. In this contribution, I relate my own pandemic story, not as one of success, but rather (...) as a humble attempt to grapple with the question of the post-pandemic philosophy curriculum. What is the place of philosophy in the twenty-first-century university? What might "philosophy" mean in a post-pandemic context... (shrink)

Eyal et al have recently argued that researchers should consider conducting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) human challenge studies to hasten vaccine development. We have conducted (J. L.) and overseen (L. D.) human challenge studies and agree that they can be useful in developing anti-infective agents. We also agree that adults can autonomously choose to undergo risks with no prospect of direct benefit to themselves. However, we disagree that SARS-CoV-2 challenge studies are ethically appropriate at this time, for (...) 3 reasons: (1) current scientific knowledge of SARS-CoV-2 infection is insufficient to manage risks; (2) autonomous decision making, while necessary, does not override concerns about risk; and (3) undertaking challenge studies now would imperil confidence in the research enterprise, potentially undermining the global response to the coronavirus disease 2019 (COVID-19) pandemic. (shrink)

The discipline of knowledge translation (KT) emerged as a way of systematically understanding and addressing the challenges of applying health and medical research in practice. In light of ongoing and emerging critique of KT from the medical humanities and social sciences disciplines, KT researchers have become increasingly aware of the complexity of the translational process, particularly the significance of culture, tradition and values in how scientific evidence is understood and received, and thus increasingly receptive to pluralistic notions of knowledge. Hence, (...) there is now an emerging view of KT as a highly complex, dynamic, and integrated sociological phenomenon, which neither assumes nor creates knowledge hierarchies and neither prescribes nor privileges scientific evidence. Such a view, however, does not guarantee that scientific evidence will be applied in practice and thus poses a significant dilemma for KT regarding its status as a scientific and practice-oriented discipline, particularly within the current sociopolitical climate. Therefore, in response to the ongoing and emerging critique of KT, we argue that KT must provide scope for relevant scientific evidence to occupy an appropriate position of epistemic primacy in public discourse. Such a view is not intended to uphold the privileged status of science nor affirm the “scientific logos” per se. It is proffered as a counterbalance to powerful social, cultural, political and market forces that are able to challenge scientific evidence and promote disinformation to the detriment of democratic outcomes and the public good. (shrink)

Through an analysis of Kafka's "Before the Law," Vardoulakis considers both various philosophical responses to Kafka's story and philosophical conceptions of the law. In particular, Vardoulakis suggests an affinity between Kafka and Spinoza's conceptions of the law.

Objective: To examine the current ethical review process of ethics committees in a non-pharmacological trial from the perspective of a clinical investigator.Design: Prospective collection of data at the Study Centre of the German Surgical Society on the duration, costs and administrative effort of the ERP of a randomised controlled multicentre surgical INSECT Trial between November 2003 and May 2005.Setting: Germany.Participants: 18 ethics committees, including the ethics committee handling the primary approval, responsible overall for 32 clinical sites throughout Germany. (...) 8 ethics committees were located at university medical schools and 10 at medical chambers. Duration was measured as days between submission and receipt of final approval, costs in euros and administrative effort by calculation of the product of the total number of different types of documents and the mean number of copies required .Results: The duration of the ERP ranged from 1 to 176 days. The median duration was 26 days at MSUs compared with 34 days at medical chambers. The total cost was €2947. 1 of 8 ethics committees at universities and 8 of 10 at medical chambers charged a median fee of €162 . The administrative effort for primary approval was 30. Four ethics committees required a higher administrative effort for secondary approval .Conclusion: The ERP for non-pharmacological multicentre trials in Germany needs improvement. The administrative process has to be standardised: the application forms and the number and content of the documents required should be identical or at least similar. The fees charged vary considerably and are obviously too high for committees located at medical chambers. However, the duration of the ERP was, with some exceptions, excellent. A centralised ethics committee in Germany for multicentre trials such as the INSECT Trial can simplify the ERP for clinical investigators in and outside the country. (shrink)

In this article, I contribute to the debate between two philosophical traditions—the Kantian and the Aristotelian—on the requirements of criminal responsibility and the grounds for excuse by taking this debate to a new context: international criminal law. After laying out broadly Kantian and Aristotelian conceptions of criminal responsibility, I defend a quasi-Aristotelian conception, which affords a central role to moral development, and especially to the development of moral perception, for international criminal law. I show than an implication of (...) this view is that persons who are substantially and non-culpably limited in their capacity for ordinary moral perception warrant an excuse for engaging in unlawful conduct. I identify a particular set of conditions that trigger this excuse, and then I systematically examine it as applied to the controversial case of former-child-soldier-turned leader of the Lord’s Resistance Army, Dominic Ongwen, who is currently at trial at the International Criminal Court. (shrink)

According to Thomas Aquinas, what distinguishes the theological from the cardinal virtues is the nature of their object: the latter aim at the natural excellence of humans, while the former direct us beyond ourselves to focus on the Divine. This paper considers the cinematic work of Drew Goddard — in particular, his 2018 film _Bad Times at the El Royale_ — as a post-religious response to Aquinas, insofar as it retains and re-presents Faith, Hope, and Love as valuable elements (...) of the human experience itself, even in the absence of a supernatural vector of their application. After the fashion of Caputo’s Derrida, I offer a religionless interpretation of each of the three theological virtues and show how _Bad Times_ itself deconstructs the roles of ‘god’ and ‘human,’ interchanging them in a way that manifests a “religionless religion” wherein the theological virtues can remain vibrant, even without the theological structure that might be expected to undergird them. In short: _Bad Times at the El Royale_ demonstrates how even if God is dead, Faith, Hope, and Love are not. (shrink)

Praised as a panacea for resolving all societal issues, and self-evidently presupposed as technological innovation, the concept of innovation has become the emblem of our age. This is especially reflected in the context of the European Union, where it is considered to play a central role in both strengthening the economy and confronting the current environmental crisis. The pressing question is how technological innovation can be steered into the right direction. To this end, recent frameworks of Responsible Innovation focus on (...) how to enable outcomes of innovation processes to become societally desirable and ethically acceptable. However, questions with regard to the technological nature of these innovation processes are rarely raised. For this reason, this paper raises the following research question: To what extent is RI possible in the current age, where the concept of innovation is predominantly presupposed as technological innovation? On the one hand, we depart from a post-phenomenological perspective to evaluate the possibility of RI in relation to the particular technological innovations discussed in the RI literature. On the other hand, we emphasize the central role innovation plays in the current age, and suggest that the presupposed concept of innovation projects a techno-economic paradigm. In doing so, we ultimately argue that in the attempt to steer innovation, frameworks of RI are in fact steered by the techno-economic paradigm inherent in the presupposed concept of innovation. Finally, we account for what implications this has for the societal purpose of RI. (shrink)

After years in distance learning, grade school teachers are now facing the threat of declining reading comprehension among elementary pupils in post-pandemic settings. Teachers observed a spike in the number of non-readers and frustrated readers in intermediate grade levels. Teachers expressed concerns about the state of the education system in the aftermath of the pandemic. The purpose of this exploratory study was to establish an understanding of the challenges and mechanisms of macro- and micro-management strategies of grade school institutions. (...) There were six teachers and six reading coordinators who participated in the study. The findings suggested that while reading comprehension was a problem before the pandemic, teachers realized a surge in the number of non-readers after opening back to face-to-face classes. This was an unanticipated phenomenon that called the academic institutions to respond immediately. Significant mechanisms of reading comprehension programs were profiling, initial detection, policy-based initiatives, and institution-based design. Collaborative and collective responsibility represented macro-management practices, while initiative and responsiveness reflected micromanagement practices. These practices and strategies provided conceptual and phenomenological underpinnings relevant to early-education reading comprehension. (shrink)

Corporate social responsibility (CSR) research has ignored the arms industry, in large part because of political assumptions that tie this industry to nation-state sovereignty. Bypassing this obsolescent Westphalian world-view, I examine the US arms industry on the basis of CSR requirements regarding the environment, social equity, profitability, and use of political power. I find the arms industry fails each of these four CSR requirements. In response to the assertion that the arms industry should not be subject to CSR requirements (...) because it is crucial to national defense, I point out that many arms manufacturers are post-Westphalian entities more powerful in their own right than many nation-states. So they should be held responsible for the foreseeable consequences that flow from use of their products, both under civil law and, where applicable, under international human rights standards. (shrink)

Praised as a panacea for resolving all societal issues, and self-evidently presupposed as technological innovation, the concept of innovation has become the emblem of our age. This is especially reflected in the context of the European Union, where it is considered to play a central role in both strengthening the economy and confronting the current environmental crisis. The pressing question is how technological innovation can be steered into the right direction. To this end, recent frameworks of Responsible Innovation (RI) focus (...) on how to enable outcomes of innovation processes to become societally desirable and ethically acceptable. However, questions with regard to the technological nature of these innovation processes are rarely raised. For this reason, this paper raises the following research question: To what extent is RI possible in the current age, where the concept of innovation is predominantly presupposed as technological innovation? On the one hand, we depart from a post-phenomenological perspective to evaluate the possibility of RI in relation to the particular technological innovations discussed in the RI literature. On the other hand, we emphasize the central role innovation plays in the current age, and suggest that the presupposed concept of innovation projects a techno-economic paradigm. In doing so, we ultimately argue that in the attempt to steer innovation, frameworks of RI are in fact steered by the techno-economic paradigm inherent in the presupposed concept of innovation. Finally, we account for what implications this has for the societal purpose of RI. (shrink)

The issue of justice after catastrophe is an enormous challenge to contemporary theories of distributive justice. In the past three decades, the controversy over distributive justice has centered on the ideal of equality. One of intensely debated issues concerns what is often called the “equality of what,” on which there are three primary views: welfarism, resourcism, and the capabilities approach. Another major point of dispute can be termed the “equality or another,” about which three positions debate: egalitarianism, prioritarianism, and sufficientarianism. (...) On these topics of distributive justice, authors are concerned with the current difference between the better-off and the worse-off or the present situation of the badly-off. By contrast, it is essential to take account of the past distribution of well-being as well as the present situation in order to explore questions of post-catastrophe justice. Without looking at the pre-disaster distribution of income, preference satisfaction, or basic capabilities among affected people, no present assessment of the damage caused by the disaster could be correct and no proposed remedy adequate. It is true that luck egalitarians assess the current distribution among people by referring to the decision that each individual made. Yet they pay scant attention to the situation in which each one stayed in the past. Therefore, we can legitimately say that most theorists of distributive justice, including luck egalitarians, have failed to give consideration to the past state of each person. -/- To fill this gap in the literature, the present article explores philosophical questions that arise when we take account of each person’s past and present situations in discussing distributive justice regarding public compensation and assistance to survivors and families of victims of natural and industrial disasters. In addressing these novel questions, I develop and refine various concepts, ideas, and arguments that have been presented in the study of distributive justice in normal settings. I tackle two tasks, the first of which is to explore the foundation and scope of luck egalitarianism. Despite the moral appeal it has in many cases, luck egalitarianism has attracted the so-called harshness objection. Some luck egalitarians attempt to avoid this objection in a pragmatic way by combining the luck egalitarian doctrine with the principle of basic needs satisfaction. However, they do not provide any systematic rationale for this combination. In contrast with such pragmatic responses, I seek to offer a principled argument for holding individuals responsible for their choices only when their basic needs are met, by invoking the ideas of respect for human voluntariness and rescue of human vulnerability. Based on this argument, I propose a form of responsibility-sensitive theory, which considers the pre-disaster distribution of well-being as a default position. The second task I take on is to refine sufficientarianism in the context of post-catastrophe justice. Luck egalitarianism with boundaries set by the basic needs principle seems to indicate the potential for sufficientarianism. But major proponents of this view conceive the welfarist assumption, a considerably high standard of well-being, and the controversial treatment of persons staying below the threshold, all of which seem problematic in the post-disaster situation. I try to construct a new version of sufficientarianism by replacing these current features with more robust ones. (shrink)

Radical enactivism, an increasingly influential approach to cognition in general, has recently been applied to memory in particular, with Hutto and Peeters New directions in the philosophy of memory, Routledge, New York, 2018) providing the first systematic discussion of the implications of the approach for mainstream philosophical theories of memory. Hutto and Peeters argue that radical enactivism, which entails a conception of memory traces as contentless, is fundamentally at odds with current causal and postcausal theories, which remain committed to a (...) conception of traces as contentful: on their view, if radical enactivism is right, then the relevant theories are wrong. Partisans of the theories in question might respond to Hutto and Peeters’ argument in two ways. First, they might challenge radical enactivism itself. Second, they might challenge the conditional claim that, if radical enactivism is right, then their theories are wrong. In this paper, we develop the latter response, arguing that, appearances to the contrary notwithstanding, radical enactivism in fact aligns neatly with an emerging tendency in the philosophy of memory: radical enactivists and causal and postcausal theorists of memory have begun to converge, for distinct but compatible reasons, on a contentless conception of memory traces. (shrink)

Objectives. The purpose of this study was to conduct the first randomized controlled trial (RCT) to evaluate the effectiveness of a second-generation mindfulness-based intervention (SG-MBI) for treating fibromyalgia syndrome (FMS). Compared to first generation mindfulness-based interventions, SG-MBIs are more acknowledging of the spiritual aspect of mindfulness. Design. A RCT employing intent-to-treat analysis. Methods. Adults with FMS received an 8-week SG-MBI known as meditation awareness training (MAT; n = 74) or an active control intervention known as cognitive behaviour theory for (...) groups (n = 74). Assessments were performed at pre-, post-, and 6-month follow-up phases. Results. Meditation awareness training participants demonstrated significant and sustained improvements over control group participants in FMS symptomatology, pain perception, sleep quality, psychological distress, non-attachment (to self, symptoms, and environment), and civic engagement. A mediation analysis found that (1) civic engagement partially mediated treatment effects for all outcome variables, (2) non-attachment partially mediated treatment effects for psychological distress and sleep quality, and (3) non-attachment almost fully mediated treatment effects for FMS symptomatology and pain perception. Average daily time spent in meditation was found to be a significant predictor of changes in all outcome variables. Conclusions. Meditation awareness training may be a suitable treatment for adults with FMS and appears to ameliorate FMS symptomatology and pain perception by reducing attachment to self. (shrink)