This chapter contains sections titled: Introduction Fundamental Ethical Principles for Research Respect for Persons: Informed Consent Beneficence Justice Vulnerability and Exploitation Research Ethics Committees Conclusion Acknowledgments References.

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 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.

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.

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 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)

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)

The concept of vulnerability is widely used in bioethics, particularly in research ethics and public health ethics. The traditional approach construes vulnerability as inherent in individuals or the groups to which they belong and views vulnerability as requiring special protections. Florencia Luna and other bioethicists continue to challenge traditional ways of conceptualizing and applying the term. Luna began proposing a layered approach to this concept and recently extended this proposal to offer two new concepts to analyze the (...) concept of vulnerability, namely understanding external conditions that trigger vulnerability and layers of vulnerability with cascading effects. Luna's conception of vulnerability is useful, which we demonstrate by applying her layered view and the new analyses in multiple contexts. We begin by outlining Luna's view and we use vignettes from healthcare involving transgender patients, the care of patients in psychiatric contexts, and research involving prisoners to illustrate how each part of Luna's concept elucidates important moral issues. (shrink)

“Vulnerability” is a key concept for research ethics and public health ethics. This term can be discussed from either a conceptual or a practical perspective. I previously proposed the metaphor of layers to understand how this concept functions from the conceptual perspective in human research. In this paper I will clarify how my analysis includes other definitions of vulnerability. Then, I will take the practical‐ethical perspective, rejecting the usefulness of taxonomies to analyze vulnerabilities. My proposal specifies two steps and provides (...) a procedural guide to help rank layers. I introduce the notion of cascade vulnerability and outline the dispositional nature of layers of vulnerability to underscore the importance of identifying their stimulus condition. In addition, I identify three kinds of obligations and some strategies to implement them. This strategy outlines the normative force of harmful layers of vulnerability. It offers concrete guidance. It contributes substantial content to the practical sphere but it does not simplify or idealize research subjects, research context or public health challenges. (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 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)

This book provides an analysis of the debate surrounding cultural diversity, and attempts to reconcile the seemingly opposing views of "ethical imperialism," the belief that each individual is entitled to fundamental human rights, and cultural relativism, the belief that ethics must be relative to particular cultures and societies. The author examines the role of cultural tradition, often used as a defense against critical ethical judgments. Key issues in health and medicine are explored in the context of cultural diversity: the physician-patient (...) relationship, disclosing a diagnosis of a fatal illness, informed consent, brain death and organ transplantation, rituals surrounding birth and death, female genital mutilation, sex selection of offspring, fertility regulation, and biomedical research involving human subjects. Among the conclusions the author reaches are that ethical universals exist, but must not be confused with ethical absolutes. The existence of ethical universals is compatible with a variety of culturally relative interpretations, and some rights related to medicine and health care should be considered human rights. Illustrative examples are drawn from the author's experiences serving on international ethical review committees and her travels to countries in Africa, Asia, and Latin America, where she conducted educational workshops and carried out out her own research. (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)

Feminist bioethicists of a variety of persuasions discuss the 2013 case of Marlise Munoz, a pregnant woman whose medical care was in dispute after she became brain dead.

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 paper evaluates four recent randomized clinical trials in which the informed consent of participants was either not sought at all, or else was conducted with critical information missing from the consent documents. As these studies have been taking place, various proposals to conduct randomized clinical trials without consent have been appearing in the medical literature. Some of the explanations offered for why it is appropriate to bypass consent or disclosure requirements appear to represent a fundamental misunderstanding of applicable government (...) regulations and even the research enterprise. Others are the result of conceptual disagreements about the importance and application of traditional research ethics norms to ‘comparative effectiveness research’ and modern research environments. Common among these explanations, however, is a failure to appreciate when a research intervention, rather than merely an observation or review of data, is taking place. Review committees and investigators are failing to see, or choosing to ignore, interventions in the lives of research subjects. When these studies have come to light, government agencies with oversight authority have done little or backed down. Prestigious medical journals have published research results knowing that the required consent was not obtained, or they have stood by the published studies even after the inadequacy of consent is discovered. This article critically examines this erosion of consent in theory and practice and calls for restoring the requirement of informed consent to its proper place as a priority in human subjects research. (shrink)

Este número de acceso abierto tiene como objetivo resaltar los puntos de vista de los países latinoamericanos sobre la justicia en un contexto de pandemia y contribuir al diálogo entre estos y con la comunidad científica global. Explora los desafíos globales de la pandemia de COVID-19, las diferencias relevantes entre las medidas de salud pública y su impacto en los países de ingresos altos versus los países de ingresos bajos o medios, y cómo la injusticia global se profundizó debido a (...) la pandemia de COVID-19. También llama la atención sobre las experiencias, los resultados y las respuestas del norte global a la pandemia con respecto a poblaciones vulnerables y trayectorias de exposición que se reproducen en América Latina. (shrink)

This open-access issue aims to highlight views about justice in a pandemic context from Latin American countries and to contribute to the dialogue between them as well as with the global scientific community. It explores the global challenges of the COVID-19 pandemic, relevant differences between public health measures and their impact on high-income countries versus low- or middle-income countries, and how global injustice deepened because of the COVID-19 pandemic. It also draws attention to experiences, outcomes, and responses to the pandemic (...) from the global north regarding vulnerable populations and exposure paths that are also present in Latin America. (shrink)

ABSTRACT This paper focuses on poverty and inequality in the world today. First, it points out how this topic is a main concern for the IAB. Second, it proposes ‘new’ theoretical tools in order to analyze global justice and our obligations towards the needy. I present John Rawls's denial that the egalitarian principle can be applied to the global sphere, his proposed weak duty of assistance, and his consideration of endemic poverty as essentially homegrown. In opposition, I focus on Thomas (...) Pogge as representative of a cosmopolitan view who also holds a critical position towards the international systems which allow and cause poverty. I endorse the general normative proposal that defends every human being as an ultimate unit of moral concern, as well as the strategy of moving away from the charity model of bilateral aid to the realm of rights and duties. These ideas should redesign and broaden the normative and practical roles of institutions, and should also help provide a new approach on bioethical issues such as drug patenting or the imbalance in global research and neglected diseases. (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)

In this article I examine some proposals for modification of ethical documents regulating research, particularly, the problems that introducing certain economic clauses may pose. I evaluate suggestions that reject the notion of providing the ‘best proven diagnostic and therapeutic method’ in favor of ‘the highest attainable therapeutic method’ or ‘the proven effective prophylactic, diagnostic and therapeutic methods’. I analyze the plausibility and problems of introducing a double standard and the consequences it may have in developing countries. Finally I highlight the (...) impact these changes may imply for these countries. (shrink)

What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in bioethics? A simple answer to both questions is that vulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. This analysis is limited to two areas. First is the context of multinational research, in which vulnerable people can be exploited even if they are not harmed, and harmed even if they are not exploited. Second is the situation of women, who are (...) made vulnerable in cultural settings or in entire countries in which they are oppressed and powerless. (edited). (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)

The Office for Human Research Protections was correct in determining that the consent forms for the National Institutes of Health -sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: how risks and benefits should be described in informed consent documents; the meaning and application of the concept of “standard of care” in the context of research; and the proper role of OHRP. Examination of the consent forms (...) reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of “standard of care” may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements. (shrink)

ABSTRACTComparative effectiveness studies, referred to here as “usual-care” trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains “unusual” care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, (...) and subjects’ safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents. (shrink)

Despite "progressive" legislative changes concerning the LGBT collective and assisted reproductive technologies (ARTs) 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)

: Following a long process of revision, a new version of the Declaration of Helsinki was approved by the World Medical Association in 2000. Two provisions of the Declaration address ongoing international controversies regarding research sponsored by industrialized countries and conducted in developing countries. Despite the issuance of the final version of the Declaration, opponents remain locked in debate. Moreover, the Declaration remained silent on other prominent controversies concerning international research. An analysis of these current controversies reveals reasons why they (...) are not likely to be readily resolved, despite apparent agreement by opponents on overarching ethical principles. (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)

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 article addresses the dilemma facing an editor when he or she has to decide whether or not to publish a manuscript that describes unethical research. I will explore three options the editor may follow: a) publish the unethical research; b) publish it with an explicit condemnation of the methods used; c) reject the article on moral grounds. I will consider the importance of deterring unethical research, why the deterrence argument has been overlooked and the relevance it has in developing (...) countries which seem to be more exposed to morally tainted experiments. I will suggest a combined policy. For cases in which the ethical problems are serious — where basic human rights are not respected, where consent has been given without complete or proper information or voluntary participation by subjects, or where deceit has been practised — I would support the strong policy of rejecting the article on moral grounds. For dubious cases, where the risk assessment can be doubted or where there are suspicions of ethical problems, I argue for a policy under which the article is published along with a serious discussion of the ethical problems suspected, allowing a rebuttal by the authors. In this way, while maintaining a strong deterrent policy, we recognize that sometimes it is not so clear if a research project was unethical, and only in such cases (where the ethical problems are dubious), the article may be published with an editorial. (shrink)

A new political movement has arisen in bioethics, self‐consciously distingushed from the rest of the ield and characterized by a new way of writing and arguing. Unfortunately, that new method is mean‐spirited, mystical, and emotional. It claims insight into ultimate truth yet disavows reason.

Rhodes seeks to defend her ‘conclusion that everyday ethics and medical ethics [are] incompatible’.1 She challenges ‘views that medical ethics is nothing more than common morality applied to clinical matters’.1 Beauchamp and Childress explicate the term ‘common morality’ at length.2 Nowhere do they claim that medical ethics is ‘nothing more than common morality applied to clinical matters’. Here is what they do say: “The origin of the norms of the common morality is no different in principle from the origin of (...) the norms of a particular morality for a medical or other profession … The primary difference is that the common morality has authority in all communities, whereas particular moralities are authoritative only for specific groups”.2 This critique discusses the seven examples Rhodes uses to illustrate her main point: that common morality and medical ethics are radically different. I contend that common morality accounts for the purported differences she cites. In ordinary life, people can simply mind their own business, whereas physicians have a duty to act in their professional setting. On this view, common morality cannot explain the moral obligation people have to prevent easily avoidable harm to others. A bystander …. (shrink)

This study explored the challenges of informed consent and understanding of the research process among Black and Latino men under community supervision. Between February and October 2012, we conducted cognitive face-to-face interviews using open-ended questions on the significant areas of research participation among 259 men aged 35 to 67 under community supervision in Bronx, New York. Content analysis of the open-ended questions revealed limited knowledge concerning the understanding of research participation. The study participants appeared to generally understand concepts such as (...) compensation after research participation and confidentiality. Participants demonstrated a lack of understanding of certain aspects of the research process—informed consent, human subject, Institutional Review Board, and clinical trials. These findings are informative to researchers conducting studies with criminal justice populations and Institutional Review Boards reviewing research studies. (shrink)

A truly global bioethics involves cooperation and collaboration among countries. Most of the articles published in bioethics journals address a problem that exists in one or more countries, but the articles typically do not discuss solutions that require collaboration or cooperation. COVAX is one example of proposed international cooperation related to the current COVID-19. pandemic. Yet it is evident that nations have been proceeding on their own with little, if any collaboration. Despite international research ethics guidance from the World Health (...) Organization, an article published under WHO auspices violates an ethical principle rejecting “double standards” in the conduct of global research. The COVID pandemic provides an opportunity for countries to learn from the recent lack of international cooperation and employ a multi-national strategy in future global health crises. (shrink)

The criteria for determining what it is to do good medical ethics are the quality of ethical analysis and ethical justifications for decisions and actions. Justifications for decisions and actions rely on ethical principles, be they the ‘famous four’ or subsidiary ethical principles relevant to specific contexts. Examples from clinical ethics, research ethics and public health ethics reveal that even when not stated explicitly, principles are involved in ethical justifications. Principles may come into conflict, however, and the resolution of an (...) ethical dilemma requires providing good reasons for preferring one principle over another. (shrink)