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)

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.

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)

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. -/- .

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)

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)

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)

¿Qué ocurre con la continuidad del tratamiento de los sujetos de investigación después de que realizan la última visita del ensayo en el que participan? En algunos casos, la falta de continuidad de atención de la salud apropiada podría poner en peligro la salud de estas personas. Por lo tanto, es probable que los sujetos de investigación que al terminar su participación en un ensayo todavía se encuentran enfermos, necesiten continuar con el tratamiento en estudio u otra atención de la (...) salud adecuada por el resto de sus vidas, sean unos pocos meses o muchos años. No obstante, no todas las sociedades cuentan con los recursos e instituciones para resolver el problema de la continuidad de tratamiento beneficioso. La opinión de un sujeto de investigación norteamericano, al que llamaremos Pedro, sin seguro de salud que participó en un ensayo de largo plazo sobre diabetes ejemplifica el problema de la continuidad de tratamiento beneficioso: “de repente [ellos] simplemente cortan la cuerda, y uno está solo por su cuenta, ya sabes. O consigues trescientos o cuatrocientos dólares al mes para seguir con esto o simplemente sigues adelante y mueres”. En este trabajo intentaré dar un panorama de la reciente discusión en torno al problema de la continuidad de tratamiento beneficioso en la ética de la investigación. Por tratamiento beneficioso hago referencia a dos cosas. En primer lugar, el tratamiento beneficioso puede ser (1) el tratamiento en estudio, p. e. el tratamiento o intervención en investigación que estaba recibiendo Pedro para su diabetes en el ejemplo anterior. Una droga o un producto biológico es un tratamiento en estudio para un uso propuesto (indicación) desde el primer ensayo con seres humanos hasta el momento en que es aprobado para su comercialización por las autoridades reguladoras de fármacos. El segundo lugar, el tratamiento beneficioso también puede ser (2) otra atención de la salud apropiada para el sujeto de investigación distinta del tratamiento en estudio, p. e. si existiera un tratamiento alternativo disponible para la enfermedad o condición de Pedro, distinto del tratamiento en estudio, y se justificara hacer la transición a ese otro tratamiento por razones de un mejor perfil de efectividad, seguridad y/o toxicidad. En la sección 1 de este trabajo introduciré una taxonomía de las obligaciones éticas de acceso posinvestigación (1.1.), realizaré un relevamiento histórico del concepto basado en las guías éticas internacionales (1.2) y analizaré el surgimiento del término “continuidad de tratamiento beneficioso hacia los sujetos de investigación” y otros términos análogos como “atención después de la investigación” (1.3). En la sección 2 presentaré los casos ejemplares en la bibliografía: continuidad de tratamiento en investigación en VIH/SIDA (2.1), continuidad de tratamiento en investigación en cáncer (2.2.) y otros casos de continuidad de tratamiento (2.3). (shrink)

Resumen Ésta es la primera traducción al español de las guías “Atención después de la investigación: un marco para los comités de ética de investigación del National Health Service (NHS) (borrador versión 8.0)”. El documento afirma que existe una fuerte obligación moral de garantizar que los participantes enfermos de un estudio clínico hagan una transición después del estudio hacia una atención de la salud apropiada. Con “atención de la salud apropiada” se hace referencia al acceso para los participantes a la (...) atención de la salud, proporcionada principalmente por el National Health Service (en adelante NHS), el sistema de salud del Reino Unido, y/o a la intervención en estudio, también llamada producto o tratamiento en investigación. Las guías “Atención después de la investigación” están dirigidas principalmente a los miembros de los 79 comités de ética de investigación del NHS y a quienes presentan sus estudios de investigación ante estos comités. Se trata de un documento borrador muy avanzado, trabajado en numerosas reuniones, durante más de 3 años, que ha sido discutido por participantes de estudios y miembros de la comunidad, miembros y presidentes de comités de ética de investigación del Reino Unido, especialistas internacionales en ética de la investigación, representantes de la industria y otras partes interesadas. La redacción de las guías es producto de la colaboración de Neema Sofaer y Penney Lewis, ambas investigadoras del King’s College London, en el Centre of Medical Law and Ethics del Dickson Poon School of Law, y Hugh Davies, Asesor en Ética de la Investigación de la Health Research Authority (HRA) del NHS. El traductor del presente documento, Ignacio Mastroleo, participó del workshop en la Fundación Brocher (Ginebra, Suiza, diciembre de 2011) donde se revisó el borrador versión 7.0 y contribuyó en la revisión del borrador de la versión 8.0 durante el 2012. -/- Abstract This is the first Spanish translation of the guidelines “Care after research: a framework for NHS RECs (8th draft)”. The document states that there is a strong moral obligation to ensure that participants in a clinical study who are ill transition after the study to appropriate healthcare. The terms "appropriate healthcare" refer to participants’ access to health care, mainly provided by the National Health Service (NHS), the health system in the UK, and/or to the intervention study also named investigational treatment or product. The guides "Care after research" are mainly directed to members of the 79 NHS committees of research ethics (RECs) and to those who submit their research to these committees. This is a very advanced draft document, worked in several meetings, for more than three years, that has been discussed with study participants and community members, members and chairs of RECs in the UK, international specialists in research ethics, industry representatives and other stakeholders. The drafting of the guidelines is the result of the collaboration of Neema Sofaer and Penney Lewis, both researchers at King's College London, at the Centre of Medical Law and Ethics of Dickson Poon School of Law, and Hugh Davies, Research Ethics Advisor of the Health Research Authority (HRA) of the NHS. The translator of this document, Ignacio Mastroleo, attended the workshop at the Brocher Foundation (Geneva, Switzerland, December 2011) where draft version 7.0 was revised and contributed in the revision of draft version 8.0 during 2012. (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)

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)

Este trabajo es un comentario sobre la primera traducción al español de las guías del Reino Unido “Atención después de la investigación: un marco para los comités de ética de investigación del NHS (borrador versión 8.0)”. El comentario se divide en tres partes. En la primera parte, se busca resumir la información básica necesaria para mejorar la lectura comprensiva de la traducción de las guías. En la segunda parte, se analiza una selección de la normativa argentina que trata sobre atención (...) después de la investigación. En la tercera parte, se presentan las principales limitaciones del borrador de las guías y su traducción. El propósito de este comentario es que los futuros lectores y lectoras puedan hacer un uso crítico y deliberado de las guías, en la evaluación de estudios clínicos o como base para la redacción de guías propias sobre atención después de la investigación. ***This work is a commentary on the first Spanish translation of the UK guidelines “Care after research: a framework for NHS research ethics committees (draft version 8.0)”. The commentary is divided into three parts. The first part seeks to summarize the basic information needed to improve reading comprehension of the translation of the guidelines. The second part analyzes a selection of Argentinean regulations dealing with care after research. The third part presents the main limitations of the guidelines draft and its translation. The purpose of this commentary is that future readers can make a critical and deliberate use of guidelines in the assessment of clinical studies or as a basis for drafting their own guidelines on care after research. (shrink)

A clear and provocative introduction to the ethics of COVID-19, suitable for university-level students, academics, and policymakers, as well as the general reader. It is also an original contribution to the emerging literature on this important topic. The author has made it available Open Access, so that it can be downloaded and read for free by all those who are interested in these issues. Key features include: -/- A neat organisation of the ethical issues raised by the pandemic. An (...) exploration of the many complex interconnections between these issues. A succinct case for a continued lockdown until we develop a vaccine. An original account of the Deep Moral Problem of the Pandemic, and a Revolutionary Argument for how we should change society post-pandemic. References to, and engagement with, many of the best writings on the pandemic so far (both in popular media and academic journals). -/- ISBN: 978-0-6489016-0-0. (shrink)

The COVID-19 pandemic highlighted the importance of internet access across various aspects of life, from remote work and online education to healthcare services and social connections. As we transition to a post-pandemic era, a pressing need arises to update our understanding of the multifaceted nature of internet access. This study is one of the first attempts to do so. Using survey data from New Zealand adult internet users (n=960), it compares internet connection types, frequency of internet use (...) at home, social media use, and concerns about online risk between people with and without disabilities. Results show people with disabilities have restricted fibre access and higher wireless broadband (a much slower connection type). People with disabilities use social media platforms less and are more concerned about certain online risks. The findings highlight persistent disparities in internet access for people with disabilities in the post-pandemic era. Implications of the study are discussed. (shrink)

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)

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)

Theories of consciousness divide over whether perceptual consciousness is rich or sparse in specific representational content and whether it requires cognitive access. These two issues are often treated in tandem because of a shared assumption that the representational capacity of cognitive access is fairly limited. Recent research on working memory challenges this shared assumption. This paper argues that abandoning the assumption undermines post-cue-based “overflow” arguments, according to which perceptual conscious is rich and does not require cognitive (...) class='Hi'>access. Abandoning it also dissociates the rich/sparse debate from the access question. The paper then explores attempts to reformulate overflow theses in ways that don’t require the assumption of limited capacity. Finally, it discusses the problem of relating seemingly non-probabilistic perceptual consciousness to the probabilistic representations posited by the models that challenge conceptions of cognitive access as capacity-limited. (shrink)

It is often claimed that epistemic bubbles and echo chambers foster post-truth by filtering our access to information and manipulating our epistemic attitude. In this paper, I try to add a further level of analysis by adding the issue of belief formation. Building on cognitive psychology work, I argue for a dual-system theory according to which beliefs derive from a default system and a critical system. One produces beliefs in a quasi-automatic, effortless way, the other in a slow, (...) effortful way. I also argue that digital socio-epistemic environments tend to inculcate disvalues in their agent's epistemic identity, a process that causes the cognitive shortcircuits typical of conspiracy theories. (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)

This article addresses the general ethical issues of accessing online personal data for research purposes. The authors discuss the practical aspects of online research with a specific case study that illustrates the ethical challenges encountered when accessing data from Kooth, an online youth web-counselling service. This paper firstly highlights the relevance of a process-based approach to ethics when accessing highly sensitive data and then discusses the ethical considerations and potential challenges regarding the accessing of public data from Digital Mental Health (...) services. It presents solutions that aim to protect young DMH service users as well as the DMH providers and researchers mining such data. Special consideration is given to service users’ expectations of what their data might be used for, as well as their perceptions of whether the data they post is public, private or open. We provide recommendations for planning and designing online research in an ethical manner that includes vulnerable young people as research participants. We emphasise the distinction between public, private and open data, which is crucial to comprehend the ethical challenges in accessing DMH data. Among our key recommendations, we foreground the need to consider a collaborative approach with the DMH providers while respecting service users’ control over personal data, and we propose the implementation of digital solutions embedded within the platform for explicit opt-out/opt-in recruitment strategies and ‘read more’ options. (shrink)

Does perceptual consciousness require cognitive access? Ned Block argues that it does not. Central to his case are visual memory experiments that employ post-stimulus cueing—in particular, Sperling's classic partial report studies, change-detection work by Lamme and colleagues, and a recent paper by Bronfman and colleagues that exploits our perception of ‘gist’ properties. We argue contra Block that these experiments do not support his claim. Our reinterpretations differ from previous critics' in challenging as well a longstanding and common view (...) of visual memory as involving declining capacity across a series of stores. We conclude by discussing the relation of probabilistic perceptual representations and phenomenal consciousness. (shrink)

Kafka’s The Trial describes how K slowly loses his familiar language. He does speak a language but his language becomes monologic towards others and the language of others becomes monologic towards K. There seems to be no other person who, in a private and professional life, can respond to K’s words and gestures in a manner which K can understand. The others embody their own meanings into K’s words. Such meanings only possess value within the discourses of self-styled legal (...) experts and officials who act in K’s name. The officials and experts assume that their own meanings are authoritative. K fails to gain access to their meanings. The question posed by Husserl’s phenomenology of language is ‘why?’ Conklin argues that K’s experiences seem not unlike Lyotard’s sense of a different or ‘untranslatable gap’. K remains on the fringe or outside what the experts take as an authoritative language. As a consequence, K’s experiential body slowly dies. This death paradoxically occurs at the same moments that the experts believe that they are addressing ‘K’s case’. Conklin explains the paradox by retrieving Husserl’s sense of a meaning-conferring act and the failure of K’s meaning-conferring acts from being fulfilled in the language of the legal experts. (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)

Human actions and decisions are most of the times not only grounded on emotional reactions, they are irrationally debasing. While such emotions and heuristics were perhaps suitable for dealing with life in the Stone Age, they are woefully inadequate in the Silicon Age. The substitution of traditional news agencies and communication platforms in Nigeria with social media networks has not only increased human capacities, it has aided the common good and further eased communication and increased the human knowledge base. For (...) instance, the Silicon Valley in the state of California in the United State of America has proved the extent to which human ingenuity can be exerted in beneficial ways. Here in, the top of the multibillion-dollar communication companies like Apple, eBay, Cisco, Lockheed, Hewlett Packard (HP), Google, Netflix, Facebook, Oracle, Tesla, etc. whose yearly budgets far exceed the entire yearly budget of Nigeria, has proved that, ICT remains the building blocks of contemporary communities. The state of California for instance prides herself as the 6th largest economy of the world after France and Brazil. This romantic picture of ICT is but only one chapter of the ICT divide. In today’s world, the scale and speed of the highly partisan news and falsehoods that circulate in the human environment is deafening. In politics and governance for instance, the populist have exploited the ICT effectively and without restraints, to access power and authority. Today, we are in the era of post-truth, an era in which objective facts are less influential in shaping public opinion than appeals to emotion and personal belief. An era that harbours corruption of intellectual integrity and damage to the whole fabric of democracy. The battle to protect information integrity and expose fake news becomes sine qua non. We shall in this paper explore the dark side of the age of information, a side that has been exploited by the media mavens, political hacks, and ideological propagandists who promote lies, illusion, confusion, and other forms of demented or manipulated imagination. In doing this, we shall proceed as follows: i. Historicize the concept of ‘fake news’ here referred to as post-truth. ii. Interrogate the concept of ‘information’ and its goal in human affairs iii. Evaluate the nexus between ‘truth’ values in ‘information’, ‘Misinformation’ and ‘dis-information’ iv. Situate the role of Philosophy in the era of post-truth. (shrink)

Faithful persons tend to relate to their religious beliefs as truth claims, particularly inasmuch as their beliefs have soteriological implications for those of different religions. For Christians the particular claims which matter most in this regard are those made by Jesus of Nazareth and his claims are primarily relational in nature. I propose a model in which we understand divine grace from Jesus as being mediated through relational knowledge of him on a compassionately exclusivist basis, including post-mortem. Supporting this (...) model, I draw from Eleonore Stump’s hypothesis in her 2018 Atonement that the crucifixion of Jesus opens the divine psyche to all human psyches sufficiently for salvific mutual indwelling to occur, and from Gavin D’Costa’s conception of the descensus Christi ad inferos as the mechanism for grace’s accessibility post-mortem presented in his 2009 Christianity and World Religions. This model seeks to address ongoing, justified pastoral concern for the soteriological status of non-Christians while still treating Christianity as objectively true. (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)

This paper sets out to defend human genetic engineering with a new bioethical approach, post-humanism, combined with a radical democratic political framework. Arguments for the restriction of human genetic engineering, and specifically germ-line enhancement, are reviewed. Arguments are divided into those which are fundamental matters of faith, or "bio-Luddite" arguments, and those which can be addressed through public policy, or "gene-angst" arguments.The four bio-Luddite concerns addressed are: Medicine Makes People Sick; There are Sacred Limits of the Natural Order; Technologies (...) Always Serve Ruling Interests; The Genome is Too Complicated to Engineer. I argue that these are matters of faith that one either accepts or rejects, and that I reject.The non-fundamentalist or pragmatic concerns I discuss are: Fascist Applications; The Value of Genetic Diversity; The Geneticization of Life; Genetic Discrimination and Confidentiality; Systematically Bad Decisions by Parents; Discrimination Against the Disabled; Unequal Access; The Decline of Social Solidarity. I conclude that all these concerns can be adequately addressed through a proactive regulative framework administered by a liberal democratic state. Therefore, even germ-line genetic enhancement should eventually made available since the potential benefits greatly outweigh the potential risks. (shrink)

The purpose of the article is to identified the origin and essence of Western individualism. Methods of research. I used the methodology of post-nonclassical metaphysics of history, as well as the methods of epistemological polytheism and comparative. Results. The first sprouts of individualism can be detected in Greek poleis. It is the crisis of the polis system in Ancient Greece that predetermined the disappointment of the Greeks in the old collectivist ideals. Roman collectivism quite naturally got along with ideas (...) about civil liberties and the dignity of an individual citizen. The idea of citizenship was brought to the theoretical perfection by moving it beyond the boundaries of city walls. The Christian ideal is not a self-sufficient person, but the community of believers. It is the weakening of the church’s position and the strengthening of the influence of Antiquity that led to the formation of the Western style of thinking, which became the basis of the new European civilizational project. John Locke rethought the Hobbesian “Roman” theory of the social contract, thereby laying the foundations of liberalism, and hence of individualism. However, radically changing the hierarchical society, even the shaken revolution and the restoration of the Stuarts, no theoretical work could not. But in the New World, free from class barriers, Locke’s ideas found a much more fertile soil. Conclusions. The Western version of individualism emerges as a civilizational ideal at the junction of two completely different paradigms — the Ancient (Greek and Roman) and the Christian. Being present in the “body” of the West, individualism could not access its code. The latter was guarded by numerous barriers, among which the Catholic collectivism and the class divisions of hierarchical society were the most powerful guards. In American society, security barriers were significantly weaker, which allowed individualism to develop in the United States. Then American individualism returned to Europe and is now perceived as an integral element of Western civilization. (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)

Russians and Westerners access, process and communicate information in different ways. Whilst Westerners favour detailed analysis of subject matter, Russians tend to focus on certain components that are, in their view, significant. This disparity makes it difficult to achieve constructive dialogues between Western and Russian stakeholders contributing to cross-cultural communication problems. The author claims that the difference in the ways Russians and Westerners negotiate information is a significant cultural difference between Russia and West rather than an irritating (and in (...) principle amenable) lack of analytical skills on the Russian partners’ part. Understanding the reasons behind the Russian-specific approaches to dealing with information would be a positive step towards a more effective cross-cultural communication, important in business situations and essential in diplomacy. (shrink)

There is a long-running debate as to whether privacy is a matter of control or access. This has become more important following revelations made by Edward Snowden in 2013 regarding the collection of vast swathes of data from the Internet by signals intelligence agencies such as NSA and GCHQ. The nature of this collection is such that if the control account is correct then there has been a significant invasion of people's privacy. If, though, the access account is (...) correct then there has not been an invasion of privacy on the scale suggested by the control account. I argue that the control account of privacy is mistaken. However, the consequences of this are not that the seizing control of personal information is unproblematic. I argue that the control account, while mistaken, seems plausible for two reasons. The first is that a loss of control over my information entails harm to the rights and interests that privacy protects. The second is that a loss of control over my information increases the risk that my information will be accessed and that my privacy will be violated. Seizing control of another's information is therefore harmful, even though it may not entail a violation of privacy. Indeed, seizing control of another's information may be more harmful than actually violating their privacy. (shrink)

The conventional wisdom regarding the aims and shortcomings of Kantian constructivism is mistaken. The aim of metaethical constructivism is not to provide a naturalistic account of the objectivity of normative facts by deriving substantive morality from a conception of agency so thin as to be uncontroversial (a task at which it is generally regarded to have failed). Its aim is to explain the “grip” that normative facts have on us—to avoid what I call the problem of normative alienation. So understood, (...) Kantian constructivism faces two problems: that determinate normative facts cannot be derived from agency and that its individualistic conception of agency cannot account for the sociality of morality. I propose and elaborate a social conception of agency that is better able to address the latter problem while still avoiding normative alienation, and evaluate two different strategies for responding to the former problem. (shrink)

Immunology researchers are beginning to explore the possibilities of reproducibility, reuse and secondary analyses of immunology data. Open-access datasets are being applied in the validation of the methods used in the original studies, leveraging studies for meta-analysis, or generating new hypotheses. To promote these goals, the ImmPort data repository was created for the broader research community to explore the wide spectrum of clinical and basic research data and associated findings. The ImmPort ecosystem consists of four components–Private Data, Shared Data, (...) Data Analysis, and Resources—for data archiving, dissemination, analyses, and reuse. To date, more than 300 studies have been made freely available through the ImmPort Shared Data portal , which allows research data to be repurposed to accelerate the translation of new insights into discoveries. (shrink)

Objective: The study seeks to provide a thorough description of the teachers' digital literacy (DL) and digital competence (DC) and shine a light on the variables that influence the development of their digital literacies and competence. Method: Comprehensive data collection and analysis from 274 participants were completed. Descriptive and inferential statistics were conducted to accomplish the objectives of this study. Results: It came to light that teachers with less than ten years of experience have higher levels of digital literacy. Pre-service (...) education, having access to ICT resources, and a favorable attitude about using ICT were all strongly associated with DL and DC. The research's essential contribution is its findings affirming the value of DL and DC, which can be utilized to approach new technologies critically and use them as a part of digital pedagogy. Novelty: The critical contribution of the research is the result claiming the positive status of DL and DC, which can be used to approach new tools from a critical pedagogical perspective and apply them as part of digital pedagogy. -/- . (shrink)

In the ever-changing landscape of education, the integration of Information and Communication Technologies (ICT) has emerged as a transformative force, reshaping traditional teaching methods and enhancing learning experiences. This study delves into the complexities of ICT adoption in Nigerian higher education, focusing on post-secondary technical education programs or National Diploma and Higher National Diploma (ND/HND) awarding institutions. The significance of this study lies in addressing challenges faced by developing nations like Nigeria, where harnessing ICT-driven education could resolve pressing issues (...) in the educational sector. The study identifies multifaceted challenges hindering ICT adoption, such as inadequate funding, lack of infrastructure, and resistance from faculty members. It emphasizes the pivotal role of knowledge sharing in higher education, underlining its significance in fostering continuous learning, collaboration, critical thinking, and innovation. Integrating ICT tools, supported by a robust digital infrastructure and tailored training programs, can mitigate these challenges. The study explores prominent knowledge-sharing models and theories, comprehensively understanding knowledge dissemination within post-secondary technical institutions. It emphasizes collaborative learning environments, ICT integration, and supportive policies as critical factors in enhancing knowledge exchange. The findings underscore the urgent need for policies that empower, technologies that enable, and mindsets that inspire. By addressing these challenges comprehensively, policymakers, educators, and stakeholders can create an educational landscape where every student and educator can thrive in the digital age. The insights from this research guide the evolution of post-secondary technical institutions in Nigeria and offer universal principles for educational institutions worldwide. The vision of a future with equal access to quality education for all is attainable through collaborative efforts and a commitment to embracing the potential of technology in higher education. (shrink)

As access to the internet continues to grow, so do concerns about its effects on individuals. This digital revolution is not without its religious implications, and it appears that opinions are divided on how religiosity is being affected. On the one hand, it is possible that the emergence of virtual Islam could lead to an increase in extremism. On the other hand, with more exposure to diverse perspectives, religious tolerance may be bolstered. This article examines the potential effects of (...) the internet and social media on religious thought, drawing upon insights from the contemporary philosophy of technology, specifically postphenomenology. In this framework, technology is seen as an active agent, influencing both the subject and the object. Additionally, this article seeks to explain the logic underlying the conflicting views in the literature. (shrink)

This article describes a case of a teenager with early complex trauma due to chronic domestic violence. Cannabis use triggered auditory hallucinations, after which the teenager was diagnosed with an acute schizophrenia-like psychotic disorder. Antipsychotic medication did not fully resolve symptoms. Eventually the teenager chose to self-medicate with LSD in order to resolve a suicidal condition. The teenager carried out six unsupervised LSD sessions, followed by an extended period of almost daily use of inhaled low-dose DMT. Psychotic symptoms were mostly (...) resolved after approximately one year. Subsequent cannabis use caused a transient relapse. -/- While his psychosis may have been due to cannabis use in the presence of a genetic predisposition, LSD and DMT did not promote psychotic symptoms in this case, and resolved the suicidal condition in one session. Additional high-dose LSD sessions and low-dose DMT sessions appeared to resolve the symptoms related to the early complex trauma. Alternatively, if psychosis is understood as a massive defense system resulting from early complex trauma, and if his psychotic symptoms were partially due to such trauma, psychedelics appeared to transcend this defense system, providing access to traumatic memories in order to allow for an integrative treatment effect. -/- Information was acquired from medical record excerpts provided by the patient, a semi-structured retrospective video interview, and follow-up interviews a year later. The present case suggests a need for further studies on the relationship between psychedelics and psychotic disorders, the feasibility of supervised vs unsupervised settings for various situations, and alternative therapeutic models for utilizing the hyperaware-hypersensitive state induced by psychedelics. With regard to self-treatment, a harm reduction approach should be adopted. Low-risk psycholytic self-treatment protocols could be developed for future use in public health care systems. (shrink)

Abstract Introduction Logically valid deductive arguments are clear examples of abstract recursive computational proce‐ dures on propositions or on probabilities. However, it is not known if the cortical time‐consuming inferential pro‐ cesses in which logical arguments are eventually realized in the brain are in fact physically different from other kinds of inferential processes. Methods In order to determine whether an electrical EEG discernible pattern of logical deduction exists or not, a new experimental paradigm is proposed contrasting logically valid and invalid (...) inferences with exactly the same content (same premises and same relational variables) and distinct logical complexity (propositional truth‐functional operators). Electroencephalographic signals from 19 subjects (24.2 ± 3.3 years) were acquired in a two‐condition para‐ digm (100 trials for each condition). After the initial general analysis, a trial‐by‐trial approach in beta‐2 band allowed to uncover not only evoked but also phase asynchronous activity between trials. Results showed that (i) deductive inferences with the same content evoked the same response pattern in logically valid and invalid conditions, (ii) mean response time in logically valid inferences is 61.54% higher, (iii) logically valid inferences are subjected to an early (400 ms) and a late reprocessing (600 ms) verified by two distinct beta‐2 activa‐ tions (p‐value < 0,01, Wilcoxon signed rank test). Conclusion We found evidence of a subtle but measurable electrical trait of logical validity. Results put forward the hypothesis that some logically valid deductions are recursive or computational cortical events. Keywords Beta‐2 band, Evoked potentials, Induced potentials, Deductive inference, Logical validity, Cortical bases of logical reasoning. (shrink)

In this dissertation, I seek to explain G.W.F. Hegel’s view that human accessible conceptual content can provide knowledge about the nature or essence of things. I call this view “Conceptual Transparency.” It finds its historical antecedent in the views of eighteenth century German rationalists, which were strongly criticized by Immanuel Kant. I argue that Hegel explains Conceptual Transparency in such a way that preserves many implications of German rationalism, but in a form that is largely compatible with Kant’s criticisms of (...) the original rationalist version. After providing background on Hegel’s relationship to the traditional rationalist theory of concepts and Kant’s challenge to it, I claim that Hegel’s central task is to provide a theory of conceptual content that allows a relationship to the objective world without being dependent on the specifically sensory aspect of the world, which Kant’s theory of concepts required. Since many interpreters deny that Hegel’s use of the term “concept” is comparable to other historical philosophers (or our own), I first show that Hegel’s critique of standard conceptions of concepts presupposes an agreement of subject matter. I then show how Hegel’s account of the “formal concept” provides the skeleton for a view of conceptual content that relies on negative relations between terms, rather than a relation to sensibility, to provide content. Hegel’s account of conceptual content is completed when he shows how a universal term is further specified so that it can determine singular objects. This occurs in its adequate form in a teleological process. I argue that Hegel’s account of teleology in the Science of Logic is an attempt to explain how and where Conceptual Transparency obtains. A teleological process is one in which a concept constitutes an object, and this means that a concept is perfectly adequate to express that thing’s nature and not merely to represent it. However, in the final chapter, I show that Hegel’s concept of teleology is meant paradigmatically to illuminate how human purposive processes have constituted a social world that is conceptually accessible to us. In this way, the primary “province” of Hegel’s rationalism is the human constructed world. (shrink)

Given the hard problem of consciousness, there are no brain electrophysiological correlates of the subjective experience (the felt quality of redness or the redness of red, the experience of dark and light, the quality of depth in a visual field, the sound of a clarinet, the smell of mothball, bodily sensations from pains to orgasms, mental images that are conjured up internally, the felt quality of emotion, the experience of a stream of conscious thought, or the phenomenology of thought). However, (...) there are occipital and left temporal brain electrophysiological correlates of the subjective experience. Notwithstanding, as an evoked signal, the change in event-related brain potential phase (frequency is the change in phase over time) is instantaneous, that is, the frequency will transiently be infinite: a transient peak in frequency (positive or negative), if any, is instantaneous in electroencephalogram averaging or filtering that the event-related brain potentials required and the underlying structure of the event-related brain potentials in the frequency domain cannot be accounted for, for example, by the Wavelet Transform or the Fast Fourier Transform analysis, because they require that frequency be derived by convolution rather than by differentiation. However, as I show, one suitable method for analysing the instantaneous change in event-related brain potential phase and accounting for a transient peak in frequency (positive or negative), if any, in the underlying structure of the event-related brain potentials is the Empirical Mode Decomposition with post-processing Ensemble Empirical Mode Decomposition. (shrink)

Students with visual impairments (VI) are among the groups of students needing specialized resources and supports for their school success. Using a scoping review, the institutional support services needed by visually impaired students were examined in this paper. It looked at different strategies for putting these students' institutional support into practice and collated such strategies into levels that can inform inclusive practices in higher institutions of learning. The study followed a PRISMA protocol to present a descriptive analysis of peer-reviewed publications (...) gathered from PubMed, Scopus, Google Scholars, and PsychInfo. Eight peer reviewed papers with a sample of 316 (303 post-secondary school students with VI and 13 teachers) were drawn for the study after eligibility assessment. It was found that post-secondary school students with VI still requires a number of institutional support modalities for their smooth career transition. Institutional support needs were described under the career challenges experienced by students with visual impairments and the needs for institutional support for building on smooth transition from school to career. It was deduced that student with VI still experiences barriers such as inadequately trained teachers, ill-equipped schools to address their needs, financial challenges, public stigma, accessibility, peer-to-peer acceptance and difficulties in learning at the university. The support needed from the institution were found to be those associated with academic support, integration into the social environment, need for institutional structural support services, and career transition intervention support. Practical implications demonstrates that educational institutions play a big part in helping visually impaired students in career transition. These implications can be built into a framework of action for institutional support for students with VI in schools as proposed in this paper. (shrink)

Government agencies and nonprofit organizations have increasingly turned to randomized controlled trials (RCTs) to evaluate public policy interventions. Random assignment is widely understood to be fair when there is equipoise; however, some scholars and practitioners argue that random assignment is also permissible when an intervention is reasonably expected to be superior to other trial arms. For example, some argue that random assignment to such an intervention is fair when the intervention is scarce, for it is sometimes fair to use (...) a lottery to allocate scarce goods. We investigate the permissibility of randomization in public policy RCTs when there is no equipoise, identifying two sets of conditions under which it is fair to allocate access to a superior intervention via random assignment. We also reject oft-made claims that alternative study designs, including stepped-wedge designs and uneven randomization, offer fair ways to allocate beneficial interventions. (shrink)

Accessing reliable and accurate information is essential to the proliferation of information through various channels. This can help individuals make informed decisions and avoid misinformation or disinformation. In such a case, creating an online information system should be prioritized to provide available data and information for planning, budgeting, and allocating resources and operational targets. This study assessed the level of satisfaction with the usability of EBEIS/LIS data and school management by the Department of Education among public secondary schools of the (...) Division of Bohol during 2019-2020. This research employed a quantitative method using the revised perception questionnaire, which underwent pilot testing using Cronbach's coefficient alpha to check the reliability level. Findings revealed that administrators, classroom teachers, and coordinators were satisfied with using data in school management. Findings revealed that administrators, classroom teachers, and coordinators were satisfied with using data in school management, satisfied with the personnel involved in facilitating the data, the information literacy given, and the ICT facilities to be used in online access data. However, some schools need more internet connectivity and more availability of posted/printed manuals and guidelines on accessing the online system. A need arises to provide a streamlined copy of the manual, which can be used as guidelines for online access, and strengthen its support in acquiring internet connectivity for all its learning facilities by partnering with internet service providers to optimize the signal. (shrink)

Can we permissibly accelerate vaccine testing even if this increases risk to study participants? During the COVID-19 pandemic, researchers, policymakers, and bioethicists debated ways in which vaccine development could be expedited. One suggestion were human challenge trials which only started after safe and efficacious vaccine had already been developed. Was this hesitation justified? Can challenge trials play a role in future pandemics? I defend both a version of challenge trials – a low-dosage challenge trial – and a faster option (...) for post-challenge trial safety testing. My argument draws on a new framework for risks in biomedical research. The new framework, embedded in a broader approach to the ethics of risk, can justify seemingly risky research while remaining strongly protective of the rights and interests of research participants. My argument furthermore draws on considerations about the connection between the risks to study participants, the benefits to nonparticipants, and the number of participants involved. (shrink)

This perspective paper analyzes the rising threat of retracted scientific works and the challenges of preventing the continued spreading and use of the retracted science; further, a framework is proposed for research and actions to effectively manage retractions in the information ecosystem. The precipitous increase in retractions of scientific publications is real and the complexity of retracting publications challenges current IR systems and people's information behaviors. Retracting published, especially peer-reviewed, papers in prestigious venues is a complex phenomenon involving various entities (...) through often time-consuming processes. These publications may be accessible from the original venues, digital archives, or free-access databases, but these systems differ in retrievability and output. Many systems do not identify the retractions or reasons for retractions; most systems do not treat the retracted paper and its related notices (retraction or correction) as an integrated entity. Studies found that many retracted publications continue to be cited post-retraction as valid science. A new threat is the widely spread of retracted publications on social media. Retracting invalid scientific publications has serious implications in the real world. Based on current findings, we propose (1) a framework for further research; (2) a DOI resolution to integrate the documents related to retraction/correction; (3) a structured facet taxonomy for representing and indexing the retracted, corrected, or republished publications in databases; (4) a retraction registry or database with personalized AI helper for researchers to tract retracted publications; (5) an approach for understanding how retracted publications are circulated on social media. (shrink)

R Core Team. (2016). R: A language and environment for statistical computing. R Foundation for Statistical Computing. Supplement to Occipital and left temporal instantaneous amplitude and frequency oscillations correlated with access and phenomenal consciousness. Occipital and left temporal instantaneous amplitude and frequency oscillations correlated with access and phenomenal consciousness move from the features of the ERP characterized in Occipital and Left Temporal EEG Correlates of Phenomenal Consciousness (Pereira, 2015) towards the instantaneous amplitude and frequency of event-related changes correlated (...) with a contrast in access and in phenomenology. Occipital and left temporal instantaneous amplitude and frequency oscillations correlated with access and phenomenal consciousness proceed as following. In the first section, empirical mode decomposition (EMD) with post processing (Xie, G., Guo, Y., Tong, S., and Ma, L., 2014. Calculate excess mortality during heatwaves using Hilbert-Huang transform algorithm. BMC medical research methodology, 14, 35) Ensemble Empirical Mode Decomposition (postEEMD) and Hilbert-Huang Transform (HHT). -/- In the second section, calculated the variance inflation factor (VIF). In the third section, partial least squares regression (PLSR): the minimal root mean squared error of prediction (RMSEP). In the last section, partial least squares regression (PLSR): significance multivariate correlation (sMC) statistic. (shrink)

Harms of medical interventions are systematically underestimated in clinical research. Numerous factors—conceptual, methodological, and social—contribute to this underestimation. I articulate the depth of such underestimation by describing these factors at the various stages of clinical research. Before any evidence is gathered, the ways harms are operationalized in clinical research contributes to their underestimation. Medical interventions are first tested in phase 1 ‘first in human’ trials, but evidence from these trials is rarely published, despite the fact that such trials provide the (...) foundation for assessing the harm profile of medical interventions. If a medical intervention is deemed safe in a phase 1 trial, it is tested in larger phase 2 and 3 clinical trials. One way to think about the problem of underestimating harms is in terms of the statistical ‘power’ of a clinical trial—the ability of a trial to detect a difference of a certain effect size between the experimental group and the control group. Power is normally thought to be pertinent to detecting benefits of medical interventions. It is important, though, to distinguish between the ability of a trial to detect benefits and the ability of a trial to detect harms. I refer to the former as power-B and the latter as power-H. I identify several factors that maximize power-B by sacrificing powerH in phase 3 clinical trials. If a medical intervention is approved for general use, it is evaluated by phase 4 post-market surveillance. Phase 4 surveillance of harms further contributes to underestimating the harm profile of medical interventions. At every stage of clinical research the hunt for harms is shrouded in secrecy, which further contributes to the underestimation of the harm profiles of medical interventions. (shrink)

A concise open-access textbook intended for an undergraduate audience, which brings together essential selections from Gandhi on nonviolence with supplementary materials, including: a preface; boxes providing examples, historical notes, extended explanations, and related philosophical work; overviews of post-Gandhian developments in nonviolence; diagrams, tables, and photos; discussion questions; reading and viewing suggestions; and a glossary.