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)

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.

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)

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)

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)

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)

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)

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)

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. -/- .

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)

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)

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 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)

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)

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)

¿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)

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)

Ontologies describe reality in specific domains in ways that can bridge various disciplines and languages. They allow easier access and integration of information that is collected by different groups. Ontologies are currently used in the biomedical sciences, geography, and law. A Biomedical Ethics Ontology would benefit members of ethics committees who deal with protocols and consent forms spanning numerous fields of inquiry. There already exists the Ontology for Biomedical Investigations (OBI); the proposed BMEO would interoperate with OBI, (...) creating a powerful information tool. We define a domain ontology and begin to construct a BMEO, focused on the process of evaluating human research protocols. Finally, we show how our BMEO can have practical applications for ethics committees. This paper describes ongoing research and a strategy for its broader continuation and cooperation. (shrink)

Ongoing and anticipated COVID-19 human challenge studies in the UK may advance our understanding of COVID-19 and facilitate the licensure of safe, effective, and easily deployable next-generation COVID-19 vaccines and boosters. We argue that international volunteer recruitment for COVID-19 human challenge trials can help promote diversity in these trials and ensure a sufficient number of eligible volunteers, both of which will increase the benefits of challenge research. We explore the ethical ramifications of dealing with unfair background conditions of global vaccine (...) injustice to expand medical research, and conclude that international recruitment for COVID-19 human challenge trials can be conducted ethically provided that several robust protections are in place for volunteers. (shrink)

This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical (...) agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials. (shrink)

The world’s first COVID-19 human challenge trial using the D614G strain of SARS-CoV-2 is underway in the United Kingdom. The Wellcome Trust is funding challenge stock preparation of the Beta variant (B.1.351) for a follow-up human challenge trial, and researchers at Imperial College London are considering conducting that trial. However, little has been written thus far about the ethical justifiability of human challenge trials with SARS-CoV-2 variants of concern. While vaccine resistance as such does not increase risks (...) for volunteers in COVID-19 challenge trials, we explore two specific characteristics of some variants that may initially be thought to make such trials unethical and conclude that SARS-CoV-2 variant challenge trials can remain ethical. (shrink)

The current global COVID-19 pandemic has led to a deep and multidimensional crisis across all sectors of society. As countries contemplate their mobility and social-distancing policy restrictions, we have a unique opportunity to re-imagine the deliberative frameworks and value priorities in our food systems. Pre-pandemic food systems at global, national, regional and local scales already needed revision to chart a common vision for sustainable and ethical food futures. Re-orientation is also needed by the relevant sciences, traditionally siloed in their disciplines (...) and without adequate attention paid to how the food system problem is variously framed by diverse stakeholders according to their values. From the transdisciplinary perspective of food ethics, we argue that a post-pandemic scheme focused on bottom-up, regional, cross-sectoral and non-partisan deliberation may provide the re-orientation and benchmarks needed for not only more sustainable, but also more ethical food futures. (shrink)

The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when (...) there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling. (shrink)

The potential for vaccines to prevent the spread of infectious diseases is crucial for vaccination policy and ethics. In this paper, I discuss recent evidence that the current COVID-19 vaccines have only a modest and short-lived effect on reducing SARS-CoV-2 transmission and argue that this has at least four important ethical implications. First, getting vaccinated against COVID-19 should be seen primarily as a self-protective choice for individuals. Second, moral condemnation of unvaccinated people for causing direct harm to others is (...) unjustified. Third, the case for a harm-based moral obligation to get vaccinated against COVID-19 is weak. Finally, and perhaps most significantly, coercive COVID-19 vaccination policies (e.g., measures that exclude unvaccinated people from society) cannot be directly justified by the harm principle. (shrink)

Interventions aiming to slow, stop, or reverse the aging process are starting to enter clinical trials. Though this line of research is nascent, it has the potential to not only prevent prolonged human suffering, but also to extend human well-being. As this line of research develops, it is important to understand the ethical constraints of conducting such research. This paper discusses some of these constraints. In particular, it discusses the ethical difficulties of conducting this research in a way that would (...) produce reliable data regarding the effectiveness of an anti-aging intervention. Clinical trials of such interventions, I argue, will be faced with a dilemma between two confounding variables. Eliminating the variables requires introducing ethically problematic research practices. Thus, researchers must either perform research in ethically problematic ways, or forego the conduct of high-impact clinical research on anti-aging interventions. (shrink)

Placebo-trials on HIV-infected pregnant women in developing countries like Thailand and Uganda have provoked recent controversy. Such experiments aim to find a treatment that will cut the rate of vertical transmission more efficiently than existing treatments like zidovudine. This scenario is first stated as generally as possible, before three ethical principles found in the Belmont Report, itself a sharpening of the Helsinki Declaration, are stated. These three principles are the Principle of Utility, the Principle of Autonomy and the Principle of (...) Justice. These are taken as voices of moral imperative. But although each has intuitive appeal, it can be shown that there are possible scenarios in which they give conflicting prescriptions. To achieve consistency, one must be subordinate to the others. The voice of utility is taken as subordinate to those of justice and autonomy and it is shown that given plausible assumptions about the level of poverty and education in the developing country targeted, the experiment is ruled morally wrong in the name of both justice and autonomy. Moreover, it is argued that no justification can be found for the inclusion of a placebo group, when strictly defined. By contrast, a ‘no- treatment’ control arm might be justified, but only when the demands of autonomy are satisfied, demands that are more stringent than they might appear. A utilitarian defence of the experiment is examined, namely that the would-be participants are in a no-loss situation, and it is shown that this defence is seriously flawed. Finally, it is concluded that there is no justification for amending the Declaration of Helsinki. (shrink)

The development of new methods in the field of prenatal testing leads to an expansion of information that needs to be provided to expectant mothers. The aim of this research is to explore opinions and attitudes of gynecologists in Germany, Poland and Russia towards access to prenatal testing and diagnostics in these countries. Semi-structured interviews were conducted with n = 18 gynecologists in Germany, Poland and Russia. The interviews were analyzed using the methods of content analysis and thematic analysis. (...) Visible in all three countries is a connection of prenatal medicine with the politically and socially contentious issue of pregnancy termination. Respondents in Poland and Russia concentrated on the topic of inadequate resources. Quality of information for expectant mothers is an important point in all three countries. Only in Germany was the issue of language barriers in communication raised. With regard to non-invasive prenatal testing (NIPT) respondents in Germany focused on the ethical issues of routinization of testing; in Poland and Russia they concentrated on fair access to NIPT. Challenges in all three countries arise from structural factors such as imprecise and prohibitive regulations, lack of resources or organization of healthcare services. These should be addressed on a political and medico-ethical level. (shrink)

This article examines a fundamental question of justice in global health. Is it ethically preferable to provide a larger number of people with cheaper treatments that are less effective (or more toxic), or to restrict treatments to a smaller group to provide a more expensive but more effective or less toxic alternative? We argue that choosing to provide less effective or more toxic interventions to a larger number of people is favored by the principles of utility, equality, and priority for (...) those worst-off. Advocates are mistaken to demand that medical care provided in low-income and middle-income countries should be the same as in high-income countries. (shrink)

Taking people’s longevity as a measure of good life, humankind can proudly say that the average person is living a much longer life than ever before. The AIDS epidemic has however for the first time in decades stalled and in some cases even reverted this trend in a number of countries. Climate change is increasingly becoming a major challenge for food security and we can anticipate that hunger caused by crop damages will become much more common. -/- Since many of (...) the challenges humanity faced in the past were overcome by inventive solutions coming from the life sciences, we are compelled to reconsider how we incentivize science and technology development so that those in need can benefit more broadly from scientific research. There is a huge portion of the world population that is in urgent need for medicines to combat diseases that are currently neglected by the scientific community and could immensely benefit from agricultural research that specifically targets their environmental conditions. At the same time efforts have to be made to make the fruits of current and future research more widely accessible. These changes would have to be backed by a range of moral arguments to attract people with diverging notions of global justice. This article explores the main ethical theories used to demand a greater share in the benefits from scientific progress for the poor. Since life sciences bring about a number of special concerns, a short list of conflictive issues is also offered. (shrink)

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)

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences, the International Conference on Harmonization's standards for industry, and the CONSORT group's reporting norms, in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's body of regulations, and information sheets by the Department of (...) Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”. (shrink)

Some placebo-controlled trials can continue ethically after a candidate vaccine is found to be safe and efficacious.

The ethics of geoengineering has gained momentum in recent academic debate. The current debates, however, is typically framed in terms of (i) the first-order question about the moral permissibility of geoengineering, and (ii) the second-order question about the distributive and compensatory issues associated with geoengineering. Both (i) and (ii) are central to decision-making about geoengineering, but they have not cover all ethical issues related to geoengineering. I argue that a preoccupation with (i) and (ii) may lead to an oversight (...) of post-implementation scenarios (PISs), which introduce different ethical issues relevant to decision-making on geoengineering. More specifically, I use the requirement of maintenance for geoengineering as an example to draw attention to PISs, and to illustrate the limit of the existing discussion in the ethics of geoengineering. (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)

Perhaps no other novel has received as much attention from moral philosophers as South African writer J. M. Coetzee’s Disgrace . The novel is ethically compelling and yet no moral theory explains its force. Despite clear Kantian moments, neither rationalism nor self-respect can account for the strange ethical task that the protagonist sets for himself. Calling himself the dog man, like the ancient Cynics, this shamelessly cynical protagonist takes his cues for ethics not from humans but from animals. He (...) does not however claim much in the way of empathy or understanding of animals, and his own odd motives remain a puzzle throughout the stages of his ethical transformation. Many scholars approach Coetzee’s text through an ethics of alterity, and even argue that Disgrace is exemplary in this regard. Kristeva’s rendition of alterity ethics brings us close to the novel’s vision, and yet the novel points towards a more primordial basis for ethics in the search for meaning through the human encounter with other animal species. (shrink)

We conducted a systematic literature review on the ethical considerations of the use of contact tracing app technology, which was extensively implemented during the COVID-19 pandemic. The rapid and extensive use of this technology during the COVID-19 pandemic, while benefting the public well-being by providing information about people’s mobility and movements to control the spread of the virus, raised several ethical concerns for the post-COVID-19 era. To investigate these concerns for the post-pandemic situation and provide direction for future (...) events, we analyzed the current ethical frameworks, research, and case studies about the ethical usage of tracing app technology. The results suggest there are seven essential ethical considerations—privacy, security, acceptability, government surveillance, transparency, justice, and voluntariness—in the ethical use of contact tracing technology. In this paper, we explain and discuss these considerations and how they are needed for the ethical usage of this technology. The fndings also highlight the importance of developing integrated guidelines and frameworks for implementation of such technology in the post- COVID-19 world. (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)

Throughout one’s career, a professional sports practitioner is confronted with various choices to make, ranging from coaching a fair match or offering opportunities for selected individuals to win; showing true sportsmanship or venturing for a better compensation; to even sticking to one’s home team or accepting a better offer. This is faced by all sports practitioners within the same industry: athletes, coaches, managers, and even team owners. In making these choices, individuals recognize essential ethical considerations. However, a primary factor that (...) influences them—albeit without them knowing—is their alienated state. The preferences of the sports practitioner mirror society’s response to the demands of the Culture Industry. He or she would opt to choose what the Industry is offering and uphold these standards. After all, sports is a social phenomenon that has undergone changes throughout the years, along with other aspects of society. It bears the impact of the Aufklärung, the true question of being enlightened and of being cultured. Thus, sports could be seen as constituting another level in the individual’s (and even society’s) alienated sphere. This paper seeks to shed light on the ethical considerations of the sports practitioner, in particular the heavy influence of the Culture Industry, the individual’s alienated state, and his or her response. I am interested in the play of power-relations among the sports practitioners and society, both dominated by the Industry. The paper does not present an exhaustive claim enlisting all considerations, but merely critiques the present setup. By presenting individuals’ (ultimately social) alienated state, I show that their choices are in fact social, even though they would seem to be solely individualistic in terms of their situated-ness in sporting events. Thus, this paper shows the heavy influence of the Industry in the continuous power relations between sports practitioners and society, as well as the alienated state of both. (shrink)

When discussing the safety of research subjects, including their exploitation and vulnerability as well as failures in clinical research, recent commentators have focused mostly on countries with low or middle-income economies. High-income countries are seen as relatively safe and well-regulated. This article presents irregularities in clinical trials in an EU member state, Poland, which were revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many European Union regulations, including European Commission directives concerning Good Clinical Practice, these irregularities (...) occurred. Causes as well as potential solutions to make clinical trials more ethical and safer are discussed. (shrink)

Introduction: There is currently no binding, internationally accepted and successful approach to ensure global equitable access to healthcare during a pandemic. The aim of this ethical analysis is to bring into the discussion a legally regulated vaccine allocation as a possible strategy for equitable global access to vaccines. We focus our analysis on COVAX (COVID-19 Vaccines Global Access) and an existing EU regulation that, after adjustment, could promote global vaccine allocation. -/- Methods: The main documents discussing the (...) two strategies are examined with a qualitative content analysis. The ethical values reasonableness, openness and transparency, inclusiveness, responsiveness and accountability serve as categories for our ethical analysis. -/- Results: We observed that the decision-making processes in a legal solution to expand access to vaccines would be more transparent than in COVAX initiative, would be more inclusive, especially of nation states, and the values responsiveness and accountability could be easily incorporated in the development of a new regulation. -/- Discussion: A legal strategy that offers incentives to the pharmaceutical industry in return for global distribution of vaccines according to the Fair Priority Model is an innovative way to achieve global and equitable access to vaccines. However, in the long term, achieving the Sustainable Development Goals will require from all nations to work in solidarity to find durable solutions for global vaccine research and development. Interim solutions, such as our proposed legal strategy for equitable access to vaccines, and efforts to find long-term solutions must be advanced in parallel. (shrink)

Ableist attitudes and structures regarding disability are increasingly recognized across all sectors of healthcare delivery. After Dobbs, novel questions arose in the USA concerning how to protect reproductive autonomy while avoiding discrimination against and devaluation of disabled persons. As a case study, we examine the Louisiana’s Department of Public Health August 1st Emergency Declaration, “List of Conditions that shall deem an Unborn Child ‘Medically Futile.’” We raise a number of medical, ethical, and public health concerns that lead us to argue (...) the declaration should be rescinded. The ethically objectionable declaration provides valuable lessons concerning how to uphold both reproductive and disability justice in a post-Dobbs landscape. (shrink)

In Québec, the Act Respecting Access to Documents Held by Public Bodies and the Protection of Personal Information provides an exception to transparency to most public institutions where public health research is conducted by allowing them to not disclose their uses of personal data. This exceptionalism is ethically problematic due to important concerns and we argue that all those who conduct research should be transparent and accountable for the work they do in the public interest.

The article entitled “Post-COVID-19: Education and Thai Society in Digital Era” has two objectives: 1) to study digital technology 2) to study the living life in Thailand in the digital era after COVID-19 pandemics. According to the study, it was found that the new digitized service is a service process on digital platforms such as ordering food, hailing a taxi, and online trading. It is a service called via smartphone. The information is used digitally. Public relations, digital marketing, and (...) living in cyberspace play an increasingly digital role. People have communication skills, use Line, Facebook, social media, have tools to search for knowledge, learn and improve themselves. People in the new era of life have a new way of life therefore there is social life in the cyber world. There should be ethics, attitudes, values, and click-on images that are linked to digital use. For a good time life, It is important to have digital intelligence (Digital Quotient) to live after post-COVID19, the digital era. (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)

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)

An issue about the privacy of the clustered groups designed by algorithms arises when attempts are made to access certain pieces of information about those groups that would likely be used to harm them. Therefore, limitations must be imposed regarding accessing such information about clustered groups. In the discourse on group privacy, it is argued that the right to privacy of such groups should be recognised to respect group privacy, protecting clustered groups against discrimination. According to this viewpoint, this (...) right places a duty on others, for example, private companies, institutions, and governments, to refrain from accessing such information. To defend the idea that the right to privacy should be recognised for clustered groups, at least two requirements must be satisfied. First, clustered group privacy must be conceived of as either a collective good or a participatory good. Since these forms of good are of the type from which no member of a group can be excluded from benefiting, the right to them is defined as a group right. Second, there must be group interests on which to base a group right. Group interests can be either the interests of those members that are a result of their being in the group or the interests of the group as a whole that transcend the interests of its members. However, this paper argues that clustered group privacy cannot be conceived of as either a collective or a participatory good because it is possible for some individuals to be excluded from benefiting from it. Furthermore, due to the lack of awareness among individuals that they are members of a clustered group and the nature of a clustered group itself, such groups cannot have the group interests necessary to establish a group right. Hence, the group right to privacy cannot be recognised for these groups, implying that the group right cannot be considered a means to protect clustered groups against discrimination. Instead, this paper suggests that moral principles need to be articulated within an ethics of vulnerability to identify the moral obligations of protecting vulnerable clustered groups. The duty owed to the vulnerable should involve refraining from accessing certain information about clustered groups in specific contexts. This duty is not engendered by the right to privacy of such groups; it is the duty owed to the vulnerable. The findings highlight the need to articulate moral principles regarding privacy and data protection to protect clustered groups in contexts in which accessing information about them could constitute a reason for discriminatory targeting. (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)

What is virtue? How can we lead moral lives? Exploring how contemporary moral philosophy has led to a revival of interest in the concepts of 'virtue', 'character' and 'flourishing', this is an accessible and critical introduction to virtue ethics. The book includes chapter summaries and guides to further reading throughout to help readers explore, understand and develop a critical perspective towards this important school of contemporary ethical thought.