In this article, we propose the Fair Priority Model for COVID-19 vaccine distribution, and emphasize three fundamental values we believe should be considered when distributing a COVID-19 vaccine among countries: Benefiting people and limiting harm, prioritizing the disadvantaged, and equal moral concern for all individuals. The Priority Model addresses these values by focusing on mitigating three types of harms caused by COVID-19: death and permanent organ damage, indirect health consequences, such as health care system strain and stress, as well as (...) economic destruction. It proposes proceeding in three phases: the first addresses premature death, the second long-term health issues and economic harms, and the third aims to contain viral transmission fully and restore pre-pandemic activity. -/- To those who may deem an ethical framework irrelevant because of the belief that many countries will pursue "vaccine nationalism," we argue such a framework still has broad relevance. Reasonable national partiality would permit countries to focus on vaccine distribution within their borders up until the rate of transmission is below 1, at which point there would not be sufficient vaccine-preventable harm to justify retaining a vaccine. When a government reaches the limit of national partiality, it should release vaccines for other countries. -/- We also argue against two other recent proposals. Distributing a vaccine proportional to a country's population mistakenly assumes that equality requires treating differently situated countries identically. Prioritizing countries according to the number of front-line health care workers, the proportion of the population over 65, and the number of people with comorbidities within each country may exacerbate disadvantage and end up giving the vaccine in large part to wealthy nations. (shrink)

In this article I examine several criticisms of the concept of vulnerability. Rather than rejecting the concept, however, I argue that a sufficiently rich understanding of vulnerability is essential to bioethics. The challenges of international research in developing countries require an understanding of how new vulnerabilities arise from conditions of economic, social and political exclusion. A serious shortcoming of current conceptions of vulnerability in research ethics is the tendency to treat vulnerability as a label fixed on a particular subpopulation. My (...) paper examines the role of this "label" metaphor in current statements of research ethics. In contrast to this prevailing "label" metaphor, my own positive account of vulnerability develops a dynamic way of understanding the structure of the concept of vulnerability based on the idea of "layers of vulnerability." I examine several cases involving women, as they are sometimes labeled as a vulnerable population and sometimes not. My analysis demonstrates the essential role of this revised concept of vulnerability in bioethics and research ethics. (shrink)

In this article, the authors focus on Argentina's activity in the developing field of regenerative medicine, specifically stem cell research. They take as a starting point a recent article by Shawn Harmon (published in this journal) who argues that attempts to regulate the practice in Argentina are morally incoherent. The authors try to show first, that there is no such ‘attempt to legislate’ on stem cell research in Argentina and this is due to a number of reasons that they explain. (...) Second, by examining the role played by different values, conflicting legal and moral views, and the influence of various actors, they attempt to show that the legislative silence regarding stem cell research may not necessarily be a manifestation of a legal/moral disconnection but rather a survival strategy for navigating the long and heated battle on the moral status of the embryo and the kind of treatment it deserves. (shrink)

This target article considers the ethical implications of providing prenatal diagnosis (PND) and antenatal screening services to detect fetal abnormalities in jurisdictions that prohibit abortion for these conditions. This unusual health policy context is common in the Latin American region. Congenital conditions are often untreated or under-treated in developing countries due to limited health resources, leading many women/couples to prefer termination of affected pregnancies. Three potential harms derive from the provision of PND in the absence of legal and safe abortion (...) for these conditions: psychological distress, unjust distribution of burdens between socio-economic classes, and financial burdens for families and society. We present Iran as a comparative case study where recognition of these ethical issues has led to the liberalization of abortion laws for fetuses with thalassemia. We argue that physicians, geneticists and policymakers have an ethical and professional duty of care to advocate for change in order to ameliorate these harms. (shrink)

This paper challenges the traditional account of vulnerability in healthcare which conceptualizes vulnerability as a list of identifiable subpopulations. This list of ‘usual suspects’, focusing on groups from lower resource settings, is a narrow account of vulnerability. In this article we argue that in certain circumstances middle-class individuals can be also rendered vulnerable. We propose a relational and layered account of vulnerability and explore this concept using the case study of cord blood (CB) banking. In the first section, two different (...) approaches to ‘vulnerability’ are contrasted: categorical versus layered. In the second section, we describe CB banking and present a case study of CB banking in Argentina. We examine the types of pressure that middle-class pregnant women feel when considering CB collection and storage. In section three, we use the CB banking case study to critique the categorical approach to vulnerability: this model is unable to account for the ways in which these women are vulnerable. A layered account of vulnerability identifies several ways in which middle-class women are vulnerable. Finally, by utilizing the layered approach, this paper suggests how public health policies could be designed to overcome vulnerabilities. (shrink)

Traditional accounts of vulnerability tend to label entire populations as vulnerable. This approach is of limited utility. Instead, this article utilizes a layered approach to vulnerability, identifying multiple vulnerabilities that older people experience. It focuses on distinguishing the different layers of vulnerability that may be experienced by the elderly in middle-income countries of Latin America. In doing so, I show how the layered approach to vulnerability functions, and demonstrate why it is more interesting and useful than the traditional approach. The (...) article achieves three things. First, it unwraps the different potential layers of vulnerability that develop in old age and the multidimensionality aspects of aging. Second, it reestablishes the usefulness of the concept of vulnerability and explains its functioning. Finally, it shows how different policies can be designed in order to address each vulnerability layer. The layered account promotes a multifaceted approach to public policy analyses and design. In this sense, the layered concept of vulnerability is an appealing concept to consider in public health ethics. (shrink)

This book presents some of the challenges bioethics in Latin America faces today. It considers them through the lenses of vulnerable populations, those incapable of protecting their own interests, such as the illiterate, women in societies disrespectful of their reproductive rights, and research subjects in contexts where resources are scarce.

Non-communicable diseases are no longer largely limited to high-income countries and the elderly. The burden of non-communicable diseases is rising across all country income categories, in part because these diseases have been relatively overlooked on the global health agenda. Historically, communicable diseases have been prioritized in many countries as they were perceived to constitute the greatest disease burden, especially among vulnerable and poor populations, and strategies for prevention and treatment, which had been successful in high-income settings, were considered feasible and (...) often affordable in low-income settings. This prioritization has reduced the communicable diseases burden globally but has left non-communicable diseases largely neglected. A new approach is urgently needed to tackle non-communicable diseases. Based on an analysis of potential features which may have underlain the different approaches to non-communicable diseases and communicable diseases until now, including acuity of disease, potential for control or cure, cost, infectiousness, blaming of individuals and logistical barriers, little ethical or rational justification can be found to support continued neglect of non-communicable diseases. Justice demands access to quality and affordable care for all. An equitable approach to non-communicable diseases is therefore strongly mandated on medical, ethical, economic, and public health grounds. Funding must not however be diverted away from communicable diseases, which continue to require attention—but concomitantly, funding for non-communicable diseases must be increased. International and multi-sectoral action is required to accelerate progress towards true universal health coverage and towards achievement of all of the sustainable development goals, such that prevention and access to care for non-communicable disease can become a global reality. (shrink)

This article examines the problems that research ethics confronts in developing countries and the impact that research in developing countries has had on research ethics. In order to show this it analyzes the first paradigmatic cases that gave rise to the ‘classic’ analysis of research ethics. Hence, in this article, many of the ethical concerns apply wherever research is conducted and are not particular to developing countries. Secondly, the article describes the complex process of research by analyzing different research actors (...) and their interests in the current research process. Thirdly, it sketches some of the recent cases that have prompted fierce ethical debate surrounding research in developing countries. (shrink)

This short article is a commentary to ‘Vulnerability in Research Ethics: A way forward’ from Margaret Meek Lange, Wendy Rogers and Susan Dodds. In their article they describe and accept my criticisms of the subpopulation approach to vulnerability and my analysis of vulnerability based on layers, but they suggest going beyond it using a taxonomy to classify layers of vulnerabilty. I argue that a) we do not need a taxonomy to classify vulnerabilities, b) the authors do not provide an adequate (...) or successful taxonomy, and c) they are unable to link their taxonomy to specific obligations. Thus I propose avoiding an approach that requires taxonomies, and suggest instead using some characteristics of layers of vulnerability. (shrink)

Throughout this essay, I will consider an argument frequently used to justify paternalistic behavior toward a specific class of persons: illiterate people. The argument states that illiterate people are uneducated, lack information and understanding, and are thus unable to make decisions. Therefore, it is argued, paternalism in their case is justified. The conclusion is that illiterate persons cannot be autonomous. The justification for this view is based on an a priori attitude: since it is impossible to communicate, physicians should decide (...) which kind of treatment the illiterate patient should receive. This argument is frequently used even though its proponents may not be aware of its implications. Given the importance and uncritical acceptance this argument has in Argentina, and also in other Latin American countries, I think it is relevant to analyze carefully what it means. I propose a thorough analysis of this argument, of its implications and an evaluation of whether it is acceptable. (shrink)

In this article I focus on two issues concerning bioethics in Argentina: reproductive health and ethics in research. Although these topics are quite dissimilar, they share a particular feature: their special relationship with context.

Throughout this essay, I will consider an argument frequently used to justify paternalistic behavior toward a specific class of persons: illiterate people. The argument states that illiterate people are uneducated, lack information and understanding, and are thus unable to make decisions. Therefore, it is argued, paternalism in their case is justified. The conclusion is that illiterate persons cannot be autonomous. The justification for this view is based on an a priori attitude: since it is impossible to communicate, physicians should decide (...) which kind of treatment the illiterate patient should receive. This argument is frequently used even though its proponents may not be aware of its implications. Given the importance and uncritical acceptance this argument has in Argentina, and also in other Latin American countries, I think it is relevant to analyze carefully what it means. I propose a thorough analysis of this argument, of its implications and an evaluation of whether it is acceptable. (shrink)

This target article considers the ethical implications of providing prenatal diagnosis and antenatal screening services to detect fetal abnormalities in jurisdictions that prohibit abortion for these conditions. This unusual health policy context is common in the Latin American region. Congenital conditions are often untreated or under-treated in developing countries due to limited health resources, leading many women/couples to prefer termination of affected pregnancies. Three potential harms derive from the provision of PND in the absence of legal and safe abortion for (...) these conditions: psychological distress, unjust distribution of burdens between socio-economic classes, and financial burdens for families and society. We present Iran as a comparative case study where recognition of these ethical issues has led to the liberalization of abortion laws for fetuses with thalassemia. We argue that physicians, geneticists and policymakers have an ethical and professional duty of care to advocate for change in order to ameliorate these harms. (shrink)

En este segundo documento nos ocupamos del aborto realizado por motivos terapéuticos o, dicho más brevemente, del aborto terapéutico. En la Argentina, el aborto plantea serios desafíos para la salud pública, ya que, pese a estar prohibido, se practica de forma clandestina y, muchas veces, insegura, poniendo en riesgo la vida y la salud de las mujeres. Por esta razón, creemos que la sociedad y el Estado deben debatir este problema y encontrar soluciones que resguarden los derechos de las mujeres. (...) El artículo 86, inciso 1, del Código Penal argentino expresamente despenaliza el aborto cuando corre peligro la vida o la salud de la mujer. En estos casos, se habla de aborto terapéutico. Esta disposición legal no suele aplicarse ni por los médicos ni por los profesionales que trabajan en la justicia, ya sea por desconocimiento o por razones ideológicas. Más aún, en muchos casos, las interpretaciones del Código Penal se apartan de su letra y restringen arbitrariamente su aplicación. Por estas razones, nos parece importante analizar este problema y proveer información sobre los aspectos legales y éticos involucrados en el aborto terapéutico en la Argentina. Este documento comienza con el relato de un caso hipotético, elaborado a partir de experiencias reales, con el objetivo de acercar al público a una situación concreta. Intercaladas en el cuerpo del relato, se desarrollan algunas reflexiones acerca de las implicaciones médicas, éticas y legales del caso. A continuación, se presenta un apartado referido al marco legal en el que se deben encuadrar los casos de aborto no punible. El documento sigue con una serie de breves recomendaciones destinadas tanto a los profesionales que trabajan en el sistema judicial como a los profesionales de la salud. Por último, se incluye un apéndice que contiene los principios que rigen la interpretación en materia penal y el glosario médico y legal, donde se pueden buscar las palabras resaltadas a lo largo del documento. (shrink)

Despite "progressive" legislative changes concerning the LGBT collective and assisted reproductive technologies in Argentina, women and their sexual and reproductive rights have been overlooked. This article presents a critical perspective of some of these legislative modifications in the country. It addresses why some legislators and society are prepared to challenge a conservative or traditional approach for certain groups while ignoring others. Several factors are at play. There is no all-inclusive explanation. I stress that a striking double standard prevails in Argentina (...) with respect to women and their sexual and reproductive rights. I also contend that powerful discrimination exists, in particular against poor women, who continue to suffer and are "punished" by the criminalization of abortion. (shrink)

This article focuses on the initial reactions to the Zika epidemic by national and international public health agencies. It presents and analyzes some responses public officials made about sexual and reproductive health at the inception of the epidemic. It also describes the different challenges and obligations faced by local and international public health agencies, as these have not been clearly outlined. The article argues that these agencies have different obligations and should fulfill them despite existing obstacles. While international agencies should (...) honor their leadership role and make recommendations at a meta-level, local agencies should provide, in the case of Zika, a framework for empowerment and grant women the freedom to achieve sexual and reproductive health so that they can avoid the consequences of this epidemic. (shrink)

This article presents some of the ethical and theoretical problems that reproductive decisions pose. I considerer the difficult situation of HIV infected women who have to decide whether to begin or continue pregnancy, knowing about the possibility of transmitting the infection. Could reproductive freedom be limited? I discuss, among others, Parfit, Harris and Purdy´s proposals. I try to show that a paternalistic solution is inadequate and argue on behalf of the importance of responsible and informed decisions on the part of (...) the mother or the parents. (shrink)

The concept of vulnerability has been hotly debated in research ethics literature. Some critics considered it a useless concept. In 2009—against some of those criticisms—I defended the importance of understanding this concept in terms of layers instead of applying it as a label given to certain subpopulations. In this paper, I present some of the limits of this analysis and I also explore the similarities and differences this approach has when compared to using a taxonomy as another answer on how (...) to assess vulnerability. I present the notion of cascade vulnerability and underscore the dispositional character of layers and their relevance to identify and evaluate layers of vulnerability. Finally, I show how this layered account has been incorporated in important documents such as the new 2016 CIOMS-WHO Guidelines. (shrink)

In this paper I analyse changes AIDS brought to research with human beings . One of the issues I consider is the relevance of ethical codes to these new proposals in research and if we are justified to think this implies a new paradigm in research . I evaluate some of the arguments activits of AIDS have done, the relevance of considering informed consent as the only criterium and I give special importance to the benefit-risk evaluation as one of the (...) necessary conditions for research work. (shrink)

El Foro Global de Bioética en Investigación (GFBR por sus siglas en inglés) se reunió el 3 y 4 de noviembre en Buenos Aires, Argentina, con el objetivo de discutir la ética de la investigación con mujeres embarazadas. El GFBR es una plataforma mundial que congrega a actores clave con el objetivo de promover la investigación realizada de manera ética, fortalecer la ética de la investigación en salud, particularmente en países de ingresos bajos y medios, y promover colaboración entre países (...) del norte y del sur.a Los participantes en el GFBR provenientes de Latinoamérica incluyeron a eticistas, investigadores, miembros de comités de ética y representantes de autoridades sanitarias provenientes de Argentina, Brasil, Chile, Colombia, Ecuador, El Salvador, Guatemala, Honduras, Panamá, Perú, Nicaragua y la República Dominicana. Una legítima preocupación por la protección de las mujeres embarazadas y sus embriones o fetos ha llevado a la mayoría de los países de la Región de las Américas a limitar la realización de estudios con mujeres embarazadas exclusivamente a aquellos estudios específicos sobre el embarazo, y a requerir la exclusión sistemática de las mujeres embarazadas o de las mujeres que quedan embarazadas en el curso del estudio. Ciertamente, a lo largo de la historia de la ética de la investigación, se ha creído erróneamente que proteger a una población es sinónimo de excluirla de los estudios. Se sabe ahora que proceder así implica exponer a riesgos mucho mayores a la población que se busca proteger. El embarazo implica cambios fisiológicos sustantivos e impacta profundamente la manera como el cuerpo metaboliza los medicamentos. Sin embargo, por evitar hacer investigación con mujeres embarazadas, no se ha producido la evidencia científica necesaria para tomar decisiones sobre tratamientos e intervenciones preventivas con dosis eficaces y seguras para ellas y sus embriones o fetos. A manera de ilustración, en el 2001 había en los Estados Unidos apenas más de una docena de medicamentos aprobados para uso en el embarazo (1) y en el 2011 la Food and Drug Administration (FDA) aprobó por primera vez en 15 años un medicamento para su uso en el embarazo (2). Como consecuencia de no haber producido la evidencia necesaria, se pone en riesgo la salud de las mujeres embarazadas cada vez que se les da atención médica. Las mujeres embarazadas se enferman y las mujeres enfermas se embarazan, y no se sabe si los medicamentos que se les da son eficaces o siquiera seguros para ellas y sus embriones o fetos. (shrink)

BackgroundCritical public health measures implemented to mitigate the spread of the novel coronavirus disease pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/aids pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network Ethics Guidance Document to situate and analyze key ethical challenges related (...) to the conduct of HIV prevention research during the COVID-19 pandemic as well as identify potential areas for refinement of the guidance document based on this unprecedented state of affairs.Main bodyNecessary actions taken for HIV prevention research studies due to the COVID-19 pandemic involve an array of ethical issues including those related to: risk mitigation; behavior change; compounding vulnerability; community engagement; trial reopening; and 6) shifting research priorities.ConclusionsIn the context of the dueling HIV and COVID-19 global pandemics, research teams and sponsors must be nimble in responding to the rapidly changing environment by being sensitive to the associated ethical issues. The HTPN EGD provides a rich set of tools to help identify, analyze and address many of these issues. At the same time, future refinements of the HPTN EGD and other research ethics guidance could be strengthened by providing explicit advice regarding the ethical issues associated with disrupted research and the reopening of studies. In addition, additional consideration should be given to appropriately balancing domains of risk, addressing the vulnerability of research staff and community partners, and responding to un-anticipatable ancillary care needs of participants and communities. Appropriately addressing these issues will necessitate conceptual work, which would benefit from the careful documentation of the actual ethical issues encountered in research, the strategies implemented to overcome them, and their success in doing so. Throughout all of these efforts, it is critical to remember that the HIV pandemic not be forgotten in the rush to deal with the COVID-19 pandemic. (shrink)