Bioethics and Vulnerability. A Latin American View. (Value Inquiry Book Series)

BIOETHICS AND VULNERABILITY A Latin American View

VIBS Volume 180 Robert Ginsberg Founding Editor Peter A. Redpath Executive Editor Associate Editors G. John M. Abbarno Mary-Rose Barral Gerhold K. Becker Raymond Angelo Belliotti Kenneth A. Bryson C. Stephen Byrum Harvey Cormier Robert A. Delfino Rem B. Edwards Andrew Fitz-Gibbon Francesc Forn i Argimon William Gay Dane R. Gordon J. Everet Green Heta Aleksandra Gylling

Matti Häyry Steven V. Hicks Richard T. Hull Mark Letteri Vincent L. Luizzi Adrianne McEvoy Alan Milchman Alan Rosenberg Arleen L. F. Salles John R. Shook Eddy Souffrant Tuija Takala Anne Waters John R. Welch Thomas Woods

a volume in Values in Bioethics ViB Matti Häyry, Tuija Takala, Editor

BIOETHICS AND VULNERABILITY A Latin American View

Florencia Luna Edited by Peter Herissone-Kelly Translated from Spanish by Laura Pakter

Amsterdam - New York, NY 2006

Cover Design: Studio Pollmann The paper on which this book is printed meets the requirements of “ISO 9706:1994, Information and documentation - Paper for documents Requirements for permanence”. ISBN-10: 90-420-2073-3 ISBN-13: 978-90-420-2073-3 ©Editions Rodopi B.V., Amsterdam - New York, NY 2006 Printed in the Netherlands

For my parents, Negra and Falucho, who instilled in me my love for the South; and for my children, Lucio and Marco, to whom I would like to transmit a similar passion for their country.

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CONTENTS Acknowledgments Introduction

xi 1

Latin American Bioethics: Some Reflections (co-author: Arleen L. F. Salles) 1. Introduction 2. Bioethics, Philosophy and Latin Americans 3. Latin American Problems

10 12

TWO

Cases and Casuistry 1. Introduction 2. Principles in Latin America 3. Casuistry: Features of the Methodology 4. Functions of the Case 5. Interpretations of Casuistry 6. Conclusion

19 19 19 21 23 25 28

THREE

Respect for Persons and the Illiterate 1. Introduction 2. The Problem of Illiteracy 3. Paternalism and Competence 4. Interpretations of the Illiteracy Argument 5. Sociological Problems and Intolerance 6. Conclusion

31 31 32 33 35 37 38

FOUR

Internal Reasons and Abortion 1. Introduction 2. Williams on Internal and External Reasons 3. External Reasons and Abortion 4. Internal Reasons and Abortion 5. Conclusion

39 39 40 42 43 46

FIVE

To Procreate or not to Procreate? AIDS and Reproductive Rights 1. Introduction 2. Reproductive Rights 3. What are the Limits on Reproduction? 4. Who Makes The Moral Decision and How? 5. Decisions in the South

49 49 49 51 59 60

ONE

9 9

viii

SIX

Assisted Reproduction and Local Experiences: Women and Context in Latin America 1. Introduction 2. Disclosure and Embryos for Transfer 3. Limits and Their Criteria 4. “Mandates and Effective Practices” 5. Double Moral Standards and Secondary Infertility 6. Embryos and Persons 7. A Problem of Reproductive Healthcare

63 63 64 65 66 67 69 71

SEVEN

Social Science Research and Respect for Persons 1. Introduction 2. A Structural Problem 3. Information and Vulnerable Populations 4. Other Possible Justifications 5. Foreign Values? 6. Abuses in Biomedical Research 7. The Weight of Ethical Codes 8. The Social Sciences and Research

73 73 73 75 77 79 80 83 84

EIGHT

AIDS, Research, and Acceptable Codes 1. Introduction 2. Ethical Questions at the Onset of AIDS 3. AIDS: The New Challenge of Globalization and Research 4. Conclusion

87 87 88

NINE

Ongoing Controversies 1. Introduction 2. The Context of the Controversy 3. Obligations During Research: The Placebo Debate 4. Arguments of a Scientific Nature 5. Social and Economic Arguments 6. Real Life Objections 7. Clarifications or Obscurities? 8. Post-Research Obligations 9. Insufficiently Considered Variables 10. Conclusion

98 108 111 111 111 112 114 117 119 120 122 125 126

ix TEN

Corruption 1. Introduction 2. The Ethical Problem 3. The Legal Problem 4. The Operational Problem 5. Changes in Current Research 6. The Phenomenon of Systemic Corruption 7. Possibilities of Corruption 8. Prevention Strategies 9. Closing Remarks

129 129 129 130 131 132 133 134 136 139

Afterthoughts

141

Notes

145

Bibliography

157

About the Author

169

Index

171

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ACKNOWLEDGMENTS I would like to thank Arleen L. F. Salles who generously co-wrote the first chapter and helped me through the first part of editing the book. I would also like to thank Rodolfo Vazquez who first published a Spanish version of the book—Ensayos de Bioética. Reflexiones desde el Sur (Mexico: Distribuciones Fontamara, 1st ed., 2001)—and encouraged me to publish an English edition. I am also grateful to Ruth Macklin for her continual support, confidence, and wise advice throughout my professional career. Finally, I would like to thank Julieta Arosteguy who gave me interesting suggestions for the Afterthoughts, and Marcelo Alegre who gave me terrific feedback on the book. I want to thank Laura Pakter for her work, patience, and support throughout the translating of the book, Natalia Righetti who helped in the editing, and Alfredo Stolarz for his generous assistance in the final stages of editing. I would like to acknowledge the journals and editors that published the first versions of some of the chapters. A first version of Chapter One originally appeared as “Develando la Bioética: Sus Diferentes Problemas y el Papel de la Filosofía,” in Perspectivas Bioéticas en las Américas, 1:1 (1996), pp. 10–22. It is published here with the authorization of the co-author Arleen L. F. Salles. A brief version of Chapter Three was read at the Second World Congress of the International Bioethics Association, and published as “Paternalism and the Argument From Illiteracy” in Bioethics, 9:3/4 (1995), pp. 283–290, and in Dilemas Eticos, ed. Mark Platts (Mexico: UNAM-FCE, 1997), pp. 151–161. Chapter Four was first presented at the Second Philosophical Colloquium in Bariloche. Chapter Six, “Reproducción Asistida y ‘Sabor Local,’ Contexto y Mujer en Latinoamérica,” Bioética (Conselho Federal de Medicina), 9:2 (2001), pp. 83–98. A version of Chapter Seven was published in Ética, investigación y ciencias sociales, ed. Ruth Macklin, Florencia Luna, et al (Mexico: Documentos de Trabajo No. 8, 2001). A version of Chapter Ten, “Corruption and Research,” was published in Bioethics, 13:3/4 (1999), pp. 262–271. The translation of this book was financed by an Early Grant Subsidy in Bioethics from Fundación Antorchas (1999–2001).

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INTRODUCTION Much has been written about ethical problems in medicine in the Anglo-Saxon world and recently in Europe. However, despite the valuable contributions this literature provides for addressing and analyzing problems, bioethics, unlike pure philosophy, is rooted in reality. Even though societies can share outcomes and theoretical approaches, bioethics presents perspectives that are specific to regions or cultures. This book examines some of the concerns that pervade Latin American society and tries to offer a different vision of some bioethical problems. It studies a recurrent question concerning bioethical issues: How can a developing society, a Latin society, with vices and virtues that differ from those in industrialized societies, approach these problems? To a greater or lesser degree, the chapters that follow echo some of the concerns of all populations marked by vulnerability, intolerance, authoritarianism, and corruption. They consider the peculiar implications that occurrence in Latin and non-mainstream Western countries can have for some bioethical and research situations. Before the content and organization of the book are presented, some comments about “vulnerability” and “developing countries” are in order, as such concepts inevitably make up part of the theme and analysis of most of the chapters. “Vulnerability” is a concept that has only relatively recently been introduced into bioethics. Rosemary Flanigan points out that “vulnerable populations” did not became a keyword descriptor in the official Bioethics Thesaurus until 1997, 1 and most of the bibliography on the subject is from 2000 on. 2 The word “vulnerability” stems from the Latin vulnerare, to wound. 3 There are two facets to this word. Onora O´Neill points out that human beings are persistently vulnerable in ways typical to the whole species, requiring protection by means of justice. In this sense, vulnerability is an expression of the human condition, the fragility and finitude of which has been a topic for many philosophers, especially those working in the continental tradition. In addition, O´Neill explains that human beings may become “deeply, variably, and selectively vulnerable to the action of the particular others and the particular institutions on whom we come to depend for specific or often unavoidable purposes.” 4 This second facet of the term gives rise to the idea of “vulnerable groups.” In bioethics, the notion of “vulnerability” has mainly featured in discussions of research ethics. The term has been used in a number of Codes of ethics. However, in the light of the characteristics set out above, it can be seen that it is a broader concept, and it seems an adequate one to address the situation of some people living in deprivation, oppression, and powerlessness— conditions that are all too common for many Latin Americans. New to bioethics though this concept is, there is an even more recent trend 5 of diminishing its importance. Some argue against the labeling and

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BIOETHICS AND VULNERABILITY: A LATIN AMERICAN VIEW

categorization of vulnerable individuals and populations because it “risks viewing vulnerable individuals as ‘others’ worthy of pity . . .” 6 or it “stereotypes them.” I believe it is far more comforting to try to evade and deny these disruptive labels than to acknowledge vulnerability and seriously provide safeguards to avoid the harmful consequences it may have. The notion of vulnerability captures significant aspects of marginalized groups. As the guidelines of the Council for International Organizations of Medical Sciences (CIOMS) 7 rightly points out, it describes persons incapable of protecting their own interests. Ignoring these aspects of some populations in Latin America may be hypocritical. Consequently, a first step is to acknowledge the vulnerability of certain populations and persons, and to try to understand why it occurs and how it may be possible to avoid it. This book addresses this issue by exhibiting the situation of some populations that are 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 considering Latin America and “developing countries,” it is worth noting how difficult it is to characterize these countries. A series of terms will be taken as synonyms: “the South,” “developing countries,” and “nonindustrialized countries.” It is clear that these are general terms that do not characterize only Latin American countries; however, all these terms have been used in Latin American political and economic analyses. In such analyses, the term “South” makes reference to some loose geographical regions in the American Continent: the North including the United States and Canada, and the South comprising Mexico downwards to Argentina and Chile. The terms “developing countries” and “non-industrialized countries” should be taken as referring to those countries’ level of economic progress. Victor B. Penchaszadeh characterizes developing countries as not having: . . . yet achieved the economic development characteristic of the industrialized nations and, as a result, [they] are generally poor, rely on the production of raw materials rather than manufactured goods, are less urbanized, and lack technological resources. 8 Despite these broad common features, this book recognizes and respects the vast heterogeneity that exists across the so-called Latin American countries. The book considers the Argentine experience primarily, and secondarily that of the rest of Latin America. The huge differences between countries like Chile, Colombia, Bolivia, Mexico, Brazil, or Uruguay should also be noted. These countries vary greatly in size and natural resources (compare tiny Uruguay to the immensity of Brazil). The constitution of their populations is also quite different, some having a high percentage of indigenous peoples, and extraordinary and sophisticated cultures (for example, the Aztecs or the Incas);

Introduction

3

others have deep roots in Africa; while in others the aboriginal population was nearly eradicated, and include vast numbers of immigrants from Europe. Finally, there are Spanish, Portuguese, and aboriginal languages— Guatemala, for example has twenty-two ethnic groups. This gives rise to ethnic, cultural, historic, and social diversity. Consequently, heterogeneity is at the very core of these countries, though they also share many common features. Their societies are generally divided by large differences in class and power, and luxury and misery live side by side. Some can access top healthcare while others live in absolute poverty, without drinking water, and suffer from malnourishment. These huge disparities, along with a common “Latin” tradition, European colonization, and the strong presence of the Roman Catholic religion, serve to characterize these countries. So, even though dissimilarities exist between the countries under consideration, this book will highlight the common ties and the impact these characteristics have on bioethical problems. The first chapter, written with Arleen L. F. Salles, presents some of the challenges bioethics in Latin America faces today. We identify two main issues. The first is the search for a secular approach to bioethics in a region in which the Catholic Church is strong, and heavily influences any kind of public ethical and bioethical discussion. We defend the need for a secular approach if Latin Americans are to construct a moral language that fits the reality of multiculturalism and religious pluralism. We also discuss the content of bioethics in Latin America. We make a distinction between two kinds of problem: the provocative (stem cell research, cloning, new genetic tests, assisted reproduction) and the boring (allocation of scarce resources, deception and breach of confidentiality, paternalism) and argue that both types are pertinent to a serious discussion about bioethics, be it in a developing or in an industrialized country. We reject the supposition that only industrialized countries should be concerned with the ethical issues raised by sophisticated technology. We take this to be a simplistic view: the latest scientific developments have a real impact on developing countries (given, for example, their slight ability to regulate and monitor). The first chapter, then, outlines the range of options and content that can be covered from a Southern perspective: nothing is foreign. A question that immediately arises is whether a more specific kind of analysis is necessary to treat these problems. Can “casuistry” take a leading role in such an analysis? Chapter Two, “Cases and Casuistry,” explores the potential of casuistry, or a casebased approach, asking whether it is an adequate theoretical tool for capturing the particularity and context of developing countries. The chapter clarifies the main principles of casuistry and examines the use of cases in relation to bioethical problems. It analyzes the ambiguities that arise in Albert R. Jonsen and Stephen Toulmin’s proposal concerning the scope and importance of cases. Chapter Three, “Respect for Persons and the Illiterate,” illustrates some sources of concern in the South, amongst them the lack of respect toward patients, patients’ vulnerability, and the intolerance that exists in Southern

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BIOETHICS AND VULNERABILITY: A LATIN AMERICAN VIEW

societies. The vulnerability of many patients in the region is rooted in the incidence of illiteracy, as evinced in the treatment they receive, their difficulty in making themselves heard, and the strong paternalistic attitudes to which they are subject. The chapter analyzes one of the most common arguments used by physicians in Argentina and elsewhere in Latin America, an argument that maintains that working with a highly illiterate population necessitates a paternalistic approach. Those who advance this argument presume that their patients are incapable of understanding or making correct decisions. Physicians, it is held, are better qualified to make the wisest decisions, and therefore must do so. This argument leads to an a priori attitude toward these patients, which the chapter challenges. Another social situation the chapter considers extensively is the denial of women’s reproductive rights and the extremely restrictive legal circumstances with respect to abortion. It serves as a backdrop to the following chapters. Based on these restrictions, “Internal Reasons and Abortion” accepts the challenge that an analysis from the Southern perspective implies. It acknowledges the restrictive position of Argentine legislation on abortion and tries to open a path toward a new kind of examination. I propose an analysis of the abortion issue taking Bernard Williams’s doctrine of internal reasoning as a starting point. I argue that Williams’s views can place the discussion on another level. If the discussion were centered on the traditional assertion about the moral status of the fetus, people would quickly confront two irreconcilable positions: either one becomes a person from the moment of conception and, therefore, an embryo has rights; or, one becomes a person at birth and lacks strong rights until that moment. These are two uncompromising positions. Here, Williams’s “internal reasoning” proposal is explored as a way to providing a more dynamic approach. The chapter proposes that tolerance ought to be exercised, and calls for a dialogue in societies in which this appears to be almost impossible. It argues for the interaction of rational agents who wish to reach a minimum consensus through dialogue, a colossal task in strongly intolerant countries. In Chapter Five, “To Procreate or Not to Procreate? AIDS and Reproductive Rights,” I question medical paternalism in such a highly controversial issue as that of patients with Acquired Immune Deficiency Syndrome (AIDS) who must choose whether to have a child and risk transmitting this serious disease to their offspring. One of my objectives is to present the theoretical problems that arise when taking these kinds of decisions: situations that range from the difficult choice of whether or not to have a child with disabilities, to the subtle distinctions between harm, wrong, and wrongdoing. Another element is the paradoxical attitude toward reproductive rights in countries in which there is no national law allowing women to be informed, to look after themselves, and to choose when to have children; and, at the same time, when infected women become pregnant they are stigmatized. Until 2002, Argentina did not have a

Introduction

5

federal law for responsible procreation. Its enactment was hindered by strong opposition. Nowadays, even if there is a federal program it is still hard to implement it adequately. As a result, until very recently women did not have access to accurate information, nor the necessary tools to decide when to have children, and poor women were thereby placed in an ever more difficult situation. “Assisted Reproduction and Local Experience: Women and Context in Latin America” analyzes the subtle influence of the Latin American context in assisted reproductive technologies. It considers the impact of technological advancements in developing countries, and the inadequacies of implementing the solutions of industrialized countries. The main issues are, once again, the lack of respect for reproductive rights (the lack of sexual education and contraception, the failure to prevent sexually transmitted diseases, the prohibition of safe abortions), the status of embryos in the culture, and the promotion of a double standard. Context cannot be ignored. It fosters, in this case, secondary infertility. This fact should shape healthcare provision by promoting an all-embracing strategy that should prevent, as well as solve, infertility problems. The remaining chapters focus on some of the ethical problems in research. “Social Science Research and Respect for Persons” takes the specific situation in social science research, where the question of obtaining informed consent or providing the research subject with information still meets with resistance. The chapter builds on some of the problems about intolerance and authoritarianism in medical practice mentioned above, and it was prompted by the publication of a book on ethics and research with Ruth Macklin. In that book, researchers in the field of reproductive health present and comment on cases and difficulties they have faced in countries like Mexico, Brazil, Chile, and Argentina. One of the recurring points is the lack of respect for research subjects. This was shown by the researchers hiding relevant information from the research subjects, failing to request their informed consent, taking their case history without consent, or intruding into their homes. I argue that these actions are incorrect. I speculate on the possible reasons for this behavior, and finally illustrate my point via an analogy with the history of abuse in biomedical research. Even if the kind of harm that biomedical research can inflict differs greatly from that of the social sciences, it does not minimize the harm that some researchers in this field can generate (especially when the research is related to stigmatized diseases and to reproductive issues that may be painful and cause anguish, like abortion or infertility). Chapter Eight, “AIDS, Research, and Acceptable Codes,” focuses on AIDS and research. It examines the impact the AIDS pandemic has had on research. The impact began in the 1980s, when the carrying out of research and therapy were questioned, along with Food and Drug Administration (FDA) policies on the regulation and marketing of new drugs. The chapter goes on to examine the criticisms that arose in the late 1990s, and in the early years of the

6

BIOETHICS AND VULNERABILITY: A LATIN AMERICAN VIEW

twenty-first century, analyzing arguments and proposals for changes in laws and international research documents. The second part of the chapter was initially written while the international research codes were being debated: the Declaration of Helsinki 9 (modified in late 2000) and the guidelines of the Council for International Organizations of Medical Sciences (CIOMS) 10 were being elaborated. However, the situation has moved on since then, and accordingly the 2002 version of the CIOMS Guidelines is considered as well as the debates that followed the Declaration of Helsinki. The revision of Codes and Ethical Guidelines is necessary due to the unprecedented developments in science and the emergence of new problems, such as genetic research in general and in specific populations, data banks, the development of the AIDS vaccine, and the use of stem cell technology. However, in early 1999, a draft of the Declaration of Helsinki was presented on the Internet and discussed by the Council of the World Health Organization in Chile. It proposed, among other changes, a double standard for the protection and care of patients: one to be used in industrialized wealthy countries, and another to be used in developing countries. I analyze the justification, the impact, and the consequences that the draft’s proposals might have on people in developing countries. In the end, the suggested alterations were not incorporated. However—given the strong defenders such a position still has—it is worth considering how these changes might have an impact on countries in the South, many of which have a long tradition of research abuse. Chapter Nine, “Ongoing Controversies,” considers two main sources of changes after the approval of the Declaration of Helsinki in 2000. It examines the debate on post-trial obligations and some of the arguments justifying the use of placebos in research in developing countries such as Uganda, Gambia, and Thailand, when a proven and effective therapy already exists. The chapter then reviews scientific, economic, and socio-cultural arguments, and cases are placed in a broader context that questions their justification. Variables that have not been satisfactorily considered are examined. Even if a knockdown argument cannot be given against making placebo use more flexible, an attempt is made to reveal the errors in the arguments for it, and to point out the elements that usually go unconsidered and that can skew an evaluation. The final chapter, “Corruption,” examines matters that are “marginally” related to research. It treats a theme that has gone practically ignored in the field of bioethics—the possibility of corruption in work settings and the existence of systemic corruption in some countries. It approaches the possible incidence of corruption in the field of research. It explores the implications of the existence of diverse levels of corruption in various countries according to empirical work on an international level, and calls for an awareness of the implications these different levels of corruption can have for the design of international research.

Introduction

7

These pages review the difficulties inherent in some developing countries (among them, the lack of respect for persons or intolerance), as well as external problems that threaten them (for example, diminished protection of already vulnerable populations). In an increasingly globalized society, let us remember that perspectives can differ, depending on whether you look at the world from the North or from the South.

Florencia Luna

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One LATIN AMERICAN BIOETHICS: SOME REFLECTIONS Florencia Luna and Arleen L. F. Salles 1. Introduction Bioethics has been defined as the critical and systematic reflection on ethical issues in healthcare, biological and medical research, and public health. 1 While the discussion of these issues is not new, in the past it had been restricted to the domains of religious studies and medicine. Following medical and technological advances in the sixties and seventies, philosophers in the United States joined the debate with a different approach. Many of them shared a common intellectual heritage—analytic philosophy—and were committed to using their skills to address the conceptual issues raised, and their knowledge of moral theory to discuss them. They tried to systematically address ethical problems in medicine from the perspective of analytic philosophy. This had two consequences. It showed how philosophy can advance the discussion of ethical problems in medicine and, in so doing, made clear how the discussion of such issues can invigorate philosophy. 2 In the United States, the emergence of modern bioethics has been characterized by a shift away from the religious and medical considerations that initially dominated the discourse to more philosophical and legal concepts. 3 Bioethics has become an established field of study that incorporates the perspectives of law, medicine, public policy, philosophy, sociology, and anthropology into the discussion, and seeks possible solutions to problems. The landscape of contemporary bioethics has been significantly enriched and transformed by the contribution of these disciplines to the identification of cultural, political, and economic factors that shape the way bioethical problems are defined and discussed. 4 In Latin America, moral problems in medicine have received a great deal of attention in recent years. By all accounts, bioethics is booming in the region. Consider the frequent conferences on bioethical issues, the increasing number of courses and degrees in bioethics, and the development of Master’s Programs in some universities. Yet, many people in Latin America still see bioethics as the undertaking of a few supposed moral experts whose goal it is to promote Catholic values and to defend the status quo. The link between the Church and bioethics in Latin America is so tight that serious public discussion of some controversial bioethical issues is often hindered. 5 Public debate over the ethics

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BIOETHICS AND VULNERABILITY: A LATIN AMERICAN VIEW

of abortion, euthanasia, and artificial reproduction—all practices that the Church has condemned—is severely limited. Public policies on these practices are strongly determined by religious considerations in several Latin American countries. 6 As a result, public discussion of bioethics in the region can rarely tackle all the ethical issues involved. In this chapter, we do three things. First, we argue that the main reason why Latin American bioethics has not been able to effect deep changes is because the prevalence of religion-oriented bioethical discourse does not foster the rigorous analysis that the discipline demands. Second, we identify and characterize two types of bioethical problems based on people’s reactions to them and their willingness to discuss them. Finally, we contend that a discussion of bioethical problems from a Latin American perspective is crucial.

2. Bioethics, Philosophy, and Latin Americans One of the main practical goals of bioethics is to guide individuals when confronting ethical and social problems in specific contexts, and to help them develop social policies to deal with those problems. We believe that for the most part, bioethics, as it is currently practiced in Latin America, is inadequate. Latin American bioethics tends to be overly-influenced by a particular religious view, which some accept uncritically. Consequently, it is not open to the insight of other perspectives. Many cultures in Latin America have been heavily influenced by Church doctrine and organization. Catholicism has traditionally played a significant role in shaping the value system of many Latin Americans. This in itself is not necessarily problematic. Religious considerations offer a particular insight and provide a unique perspective on the world and human behavior that should not be disqualified a priori. Furthermore, since bioethical issues are invariably contextually-situated, history, culture, and societal considerations are important factors in moral deliberation. But religious considerations should not shape the entire public discussion of moral issues and public policy. Insofar as this is what occurs in most Latin American countries, bioethical discussions are largely inadequate in clarifying some of the main issues. The main reason for this inadequacy is that bioethical discourse in Latin America seems to assume a homogeneity that does not exist, ignoring the reality of multiculturalism and moral and religious pluralism. Latin Americans do not constitute a homogeneous group; different voices and perspectives exist on a diversity of issues. In general, Latin American bioethics has shown no interest in seriously considering and understanding values held by other traditions and perspectives, or in critically examining the values that it endorses. Some of the most outspoken bioethicists in the region appear to accept the moral authority of one religious tradition without question.

Latin American Bioethics: Some Reflections

11

This does not imply that a secular approach to bioethics is non-existent. A small group of bioethicists in academic centers in Argentina, Mexico, Chile, and Brazil have been developing an alternative bioethical discourse that does not rely on uncritical acceptance of traditional or religious values. These bioethicists use argument to discuss issues and to develop accounts that can endure critical scrutiny. However, they operate under some constraints; their views are often rejected in public discussions of pressing issues, such as abortion and contraception, and their power to influence public debate is quite limited. In the United States some authors complain about the secularization of bioethics and call for the “use of at least some of the insights and perspectives of religion.” 7 In contrast, in Latin America the predominantly religious ethos needs to be challenged in order to construct a moral language appropriate to a diverse audience and community. This is for three reasons. First, persons who are not practicing Catholics make medical decisions and face bioethical dilemmas in Latin America. Not all of them hold the same moral framework, and their voices must be heard. Second, if bioethics is to shape policies that affect all individuals, its principles must be amenable to rational criticism. Religious considerations are immune to such criticism and therefore should not be the only basis for legal and moral decision-making. Finally, a bioethics based on religious or absolute beliefs leaves no room for a genuine dialogue. In this regard, philosophical thinking is a valuable tool. While philosophers play a considerable role in bioethical discussions in the United States, they have been conspicuously absent in Latin American bioethics until very recently. Even today, their contribution is still seriously questioned. The controversial topic of the relation between ethical theory and bioethics has been discussed frequently by bioethicists. 8 Settling this issue would take us far from our objective in this chapter and is not essential to the main point we want to make. For our purposes, it is sufficient to understand that one of the aims of philosophy is to reflect critically on beliefs and convictions and to uncover their underlying assumptions and presuppositions. A true philosophical approach to a moral issue entails disciplined and rigorous reflection, the identification of significant elements, the clear analysis of the considerations that are relevant to its resolution, and an examination of its implications and consequences. As this is also one of the main goals of bioethics, it is useful to consider it as a form of philosophical reasoning. Another reason exists why philosophy can contribute to bioethics. The analysis of moral dilemmas in medical contexts opens up a set of philosophical issues that have to do with moral accountability, responsibility, justice, autonomy, personhood, the value of human life, and the nature and justification of human rights. While it is true that other disciplines have morally relevant insights into such issues, it is undeniable that these topics are an essential concern of philosophers. A rigorous philosophical treatment of pressing problems such as reproduction, contraception, and medical decision-making is

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BIOETHICS AND VULNERABILITY: A LATIN AMERICAN VIEW

instrumentally valuable, since it fosters understanding of the main issues and so may lead to better healthcare. But this does not mean that tradition and religious considerations should be dismissed from the field of bioethics. Discussion of the moral norms that will ultimately help people resolve bioethical problems often requires the balance and interaction of a variety of values, religious ones among them. But they must be critically scrutinized so that we accept what we can rationally defend. That philosophy plays a crucial role in bioethical discourse or that it is a form of philosophical reflection does not imply that bioethics is strictly philosophy. The interdisciplinary nature of bioethics is undeniable. But, the interaction between different perspectives without the crucial contribution of philosophy can lead to an aimless discourse, or one that by heeding the demands of diverse groups of persons ends up justifying presupposed values and legitimizing the status quo.

3. Latin American Problems A. Diverse Issues When focusing on how people perceive the content of bioethical reflection, it is possible to make a distinction between two kinds of issues. Some bioethical issues grab the public spotlight and are eagerly discussed on talk shows and on the news. These issues get wide “coverage.” They are written about, not necessarily with the aim of deepening the public’s understanding of the issues, but rather with the aim of rallying people around some views. As a result, opinions are easily formed and sides are taken. Such is the case with issues like sex selection, the use of stem cells, the cloning of mammals, and the mapping of the human genome. Let us call issues of this sort “provocative” issues. In contrast, other issues receive far less attention and do not hold the public’s interest. They describe everyday situations, not gripping ones. In general, they do not attract the media and are neither debated nor presented seriously and consciously in the community. Among them we find, for example, the problem of allocation of health-care resources, deception and breach of confidentiality in the patient-physician relationship, the exploitation of vulnerable populations, medical decision making, and medical paternalism. These issues are perceived as all too common; their existence at times are taken for granted. Underlying the apathy produced by these problems is the idea that little or nothing can be done to solve them, so they are not worth discussing. Let us call this second set of issues “boring.”

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B. Provocative and Boring Problems The criterion used to make the distinction between provocative and boring problems is based on the interest they arouse in the media and in the public as a whole. This point is significant. Although the media has a tendency to privilege “provocative” problems, healthcare providers are often more immediately concerned with the “boring” problems. However, providers and the media acknowledge both types of problems and make a distinction between them. The following are some features that can help differentiate between them. (1) The level of agreement or disagreement each of these issues involves. “Provocative” issues are decidedly controversial. People hold strong positions for or against them. Consider the current debate over stem cell research. In contrast, “boring” issues tend to elicit a consensus. It is easy to agree that ethics committees are necessary. The difficult question is deciding whether patients and their families should be included, or establishing what criteria ought to be used when incorporating members of the community. Indeed, an overall consensus exists that a good physician-patient relationship is highly desirable: the discrepancies arise over the patient’s degree of autonomy or the beneficence of the physician. (2) Understanding and knowledge of the facts. When it comes to a discussion of provocative problems, most people take for granted that they have the necessary knowledge to make definite judgments or that their judgments require no more justification than that provided by their feelings. Insofar as opinions on a number of key issues are not preceded by a careful and responsible examination of the issues at stake, those opinions could be pre-reflective and superficial. By contrast, the discussion of boring problems emerges from careful reflection on the relevant issues. Should family members be consulted in medical decision making? How should ethics committees be implemented? No one can begin to answer any of these questions without a basic knowledge of the appropriate variables. (3) Scientific and technological developments. Provocative problems are closely tied to the advances of science and technology and the rapid acquisition of biological knowledge. They charm, fascinate, and haunt people: the ghost of science fiction coming alive or the fantasy of technology taking on life, like the Sorcerer’s broom. 9 By contrast, boring problems are generally remote from miracles and scientific wonders; they provoke neither perplexity nor excitement. They require us to address deeper social and economic issues that are very complex and, at times, go undetected. (4) Human power and invulnerability. Provocative problems make people think that human capability, inventiveness, and creativity are unlimited. As a consequence, provocative problems produce a sensation of invulnerability. If humans can stop the aging process, if they can create human life in test tubes, if

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they can replicate loved ones, then there is not much they cannot do. The question becomes: What are the moral limits to the power of individuals? In contrast, boring problems typically address issues that point to human vulnerabilities. They are about improving relationships, satisfying basic human needs, and forging common goals. They confront human beings with their weaknesses and limitations. C. Specific Problems, Specific Countries? Despite different social conditions, no country is immune to the issues that bioethicists explore. All societies must reflect on the ethical dimension of death and dying, illness, the distribution of healthcare resources, and the new reproductive technologies, to name but a few issues. Yet are some bioethical problems more germane to some contexts than to others? The view that a few issues are more relevant in Latin American can be supported by two kinds of considerations: economic and cultural. From an economic standpoint, it has been argued that issues related to lack of access to healthcare are more significant in developing countries than in industrialized ones, and so a discussion of those issues should take priority in the region. Conversely, provocative problems related to techno-scientific achievements would not be pertinent to Latin American countries which are not wealthy, and therefore allegedly lack a high level of medical technology. However, this view is inaccurate. It is true that in Latin America a considerable portion of the population lives in extreme poverty, and that many people have little or no access to healthcare. Undoubtedly, the topic of justice and the distribution of scarce resources is one of the most important bioethical issues in the region. But this topic is also crucial in countries with greater resources. That some nations are wealthier than others does not mean that their resources are appropriately distributed, or that they have solved allocation problems. Indeed, some attempted solutions to the problem of distribution of healthcare resources are inadequate, or do not go far enough in attending to the practical realities of people’s lives and in examining how power and control play a role in the provision of healthcare. Consider the United States, where more than 40,000,000 people have inadequate health coverage or none at all. The existence of cases such as this makes it hard to plausibly argue that the issue of the distribution of healthcare resources is crucial only in developing countries. Provocative problems, on the other hand, are not just raised in industrialized countries. Technology knows no frontiers and many problems raised by technological advances have invaded Latin America in a relatively short timespan. 10 Most major cities in Latin American countries are equipped with hightech medical facilities that provide care to those who can pay for them. At this level, the ethical issues raised by the new reproductive, genetic and organ transplantation technologies, for example, are very similar to the problems raised by those techniques and procedures in any industrialized country.

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From a cultural standpoint, it has also been suggested that notions that play a crucial role in the bioethical discourse in the United States and other Western countries are not as relevant in Latin America, where socio-economic factors are supposed to trump all other kinds of concerns. Consider the notion of autonomy and the principle of respect for persons in the medical context. There is a prevalent belief that Latin Americans are not particularly concerned with their rights to make medical decisions, and favor a more collectivist orientation. This is a misconception. It is true that the violation of basic rights has not been uncommon in the region in the past. Even now, many social and political behaviors in Latin American countries do not foster respect for rights. However, many Latin Americans are concerned with their autonomy, and they demand the conditions that will allow the effective realization of their rights and liberties. 11 Latin Americans from different backgrounds complain about medical paternalism and agree on the significance of making the kind of decisions about their lives that will allow them to protect their health. In Latin America, as in industrialized countries, provocative and boring problems co-exist. Avoiding an excess of undesired de facto circumstances and the introduction of new techniques without an adequate legal or social framework means carefully examining and discussing all of these issues. But if the bioethical problems are basically the same, why is it important to examine them from the perspective of developing countries? Could Latin Americans not just use the perspective of bioethicists from industrialized countries who have been discussing these issues much longer and apparently more fruitfully? Our answer begins with a refusal to minimize the situatedness of the problems involved. Even if the ethical issues are the same, they manifest themselves in somewhat different ways in Latin America, where different countries have diverse legal frameworks and social realities. So, a serious discussion of bioethical issues in Latin America is vital for two reasons. The first is that such a discussion will examine the issues in context, taking into account those particularistic factors that impact their resolution. In this sense, such a discussion has the potential for having much to say in particular to Latin Americans who wrestle with these issues, and to policy makers with the potential to affect the lives of those whose health is at stake. The second reason is that a good deal can be learned from the persistent impediments that many suffer in Latin America. In this sense, a serious Latin American bioethics can enrich bioethical discourse in general, offering new insights that will heighten awareness of the situation of millions of persons in the world. These points can be illustrated by considering genetic research. The questions that genetic research raises in Latin America are not only “Who will have effective access to genetic technology?” or “How will the problem of ‘benefit sharing’ or patents be solved?” These are questions that are also widely discussed in industrialized countries. Genetic research raises other issues that hold to a lesser extent in industrialized countries, such as “How will these

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developments be regulated and monitored in countries that historically lack this type of control?” “How will the corruption and the lack of transparency that appears to be typical of many Latin American countries affect the ethical use of these procedures?” “What should be the use of prenatal diagnoses in societies where abortion for genetic reasons is illegal?” These questions cannot be answered without addressing specificities that play an important role in shaping the lives of Latin Americans. The influence of different variables, such as the prevalence of poverty, authoritarian attitudes, lack of respect for human rights, and corruption must be understood and examined. By taking them into consideration we avoid the tendency to transplant both problems and solutions from other countries. The challenge is to explore a problem with its own profile, even when it may have a universal nature. However, the usefulness of a Latin American perspective on genetic research extends beyond the consequences it would have for Latin Americans themselves. It can enrich the general discussion of genetics and help to determine general areas of interest and priorities. For example, in industrialized countries, research focuses on locating actual genes or gene markers for disease such as Sickle Cell, Alzheimer’s, Parkinson’s, and Huntington’s, and on understanding the interplay between those genes and developmental and environmental factors so as to find effective means to prevent and treat the diseases to which they give rise. Yet the main causes of morbidity and mortality in the Third World cannot be attributed to genetic diseases, Parkinson’s, or Alzheimer’s, but to poverty, malnutrition, and communicable diseases. Considering that many people in the world live in developing countries, it is crucial to redirect genetic research to investigate the main causes of death and illness in countries where life expectancy is far lower than in industrialized countries, and where the threatening illnesses are different from those prevalent in developed societies. Considering genetics beyond the traditional medical setting, studying pathogen and vector genomics in order to prevent communicable diseases is vital. At present, such an innovative use of genetics is illustrated by current studies on mosquitoes and malaria in the area of host-parasite/virus relationships and vector genomics. This kind of research has important implications for the diagnosis, prevention, and treatment of malaria and other communicable diseases that affect large sectors of the population in developing countries. D. Bioethics and Developing Countries Can bioethics play a role as a form of public discourse that effectively guides behavior and shapes policies in developing countries? It can, and the development of this discipline is both necessary and significant. Industrialized and developing countries share common problems. But bioethical issues are socially embedded, shaped by customs, traditions, and values. It is necessary to study these special aspects of our societies, to analyze what to accept and why.

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This, in turn, must lead to a discussion about the universality of certain rights, the weight of traditions, customs, and ideologies, to what extent they can be accepted, and to what extent they cannot. Developing countries can offer a distinctive approach that helps to frame and to identify the issues at hand from a different perspective. Indeed, this possibility calls for a serious discussion, a rational dialogue, and a deep analysis from these “new” perspectives.

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Two CASES AND CASUISTRY 1. Introduction Do new perspectives on traditional bioethical problems require a particular theoretical account? How does bioethical theory deal with specific situations? These questions should be considered in the ongoing theoretical discussion about suitable methods in bioethics. Is case-based reasoning or casuistry a fitting theoretical tool to address particularity? What weight should cases and casuistry have in theoretical reflection? The current chapter begins with some reflections on the theory of principles, outlining its impact and criticisms in Latin America, and questions whether casuistry serves as an alternative theory in bioethics. It will try to show that casuistry, at most, can complement ethical principles. The chapter tries to clarify the role of the case in moral argumentation as it is presented by the advocates of contemporary casuistry. First, it gives a brief analysis of the casuistical method, drawing from Albert R. Jonsen and Stephen Toulmin’s classic The Abuse of Casuistry. Second, it examines the role that cases can play. And third, it analyzes the implications of two different conclusions that Jonsen and Toulmin draw with respect to their own positions.

2. Principles in Latin America One of the “standard” proposals that carries most weight in the bioethical world is Tom Beauchamp and James Childress’s theory of principles, otherwise known as “the four principles approach,” or “principlism.” 1 Beauchamp and Childress’s theory proposes four prima facie principles: respect for autonomy, beneficence, nonmaleficence, and justice. It accepts the possibility of genuinely irresolvable dilemmas. Several later theories have focused on principles in bioethics 2 or on moral rules. 3 In recent years, a strong critique of “principlism” has emerged in bioethics, and casuistry has come to be considered a possible rival theory. Principles have had a major impact on the development of bioethics in Latin America. A comprehensive analysis of Latin American bioethics goes beyond this chapter. Note, though, that Latin American physicians frequently speak of principles in lectures, in the media, or in analyses, despite the absence of explicit defenders of principles in bioethical publications. For example, the introductory course at the School of Medicine at the University of Buenos Aires is based mainly on Beauchamp and Childress’s book. Some dissident

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voices champion a more European influence, re-elaborating the approaches of Immanuel Kant, Karl O. Apel, Jurgen Habermas, and Hans Jonas. 4 However, these approaches do not have a pervasive impact on physicians’ ethical thinking. Something similar can be seen in Brazil regarding the theory of principles. Consider, for example, Debora Diniz, Dirce Guilhem, and Volnei Garrafa’s analysis. These well-known Brazilian bioethicists confirm the impact this theory has had there: The emergence and the consolidation of bioethics in Brazil is associated with the spread and popularization of the principlist theory, proposed by Tom Beauchamp and James Childress in Principles of Biomedical Ethics, especially regarding the ideas in the first three editions of the book (1979, 1983, 1989). Today the principlist theory is, without a shadow of a doubt, the bioethics theory with the greatest penetration among students of bioethics as well as among bioethics practitioners in Brazil, to such an extent that some Brazilian researchers take the principlist theory as equivalent to bioethics itself. 5 The prevailing version of the principlist theory seems to be a kind of “straw man” view of itself. Most physicians use a simplistic understanding of principles. The theory is depicted as an extreme deductive system that should be used almost as an algorithm. Note Diniz, Guilhem, and Garrafa’s comment when they indicate the widespread diffusion of the first three editions of the Beauchamp and Childress book. These editions, effectively, are characterized by a simpler view that emphasizes the deductive aspect of principlism. In agreement with these authors, we must acknowledge how common this view of the theory is, especially among those who are only just beginning to work on these issues. Even though the four principles approach was first presented as a version of deductivism, today it comes closer to a “coherence” strategy. From the beginning, Beauchamp and Childress admitted their debt to David Ross’s prima facie principles. As their theory began to be criticized by diverse theoretical proposals in bioethics, its authors, especially in the fourth edition of their book, defended a “coherentist” foundation with greater clarity and appealed to the notion of reflective equilibrium. A reading of the first chapters of the third and fourth editions of Principles of Biomedical Ethics, 6 in which the different theoretical commitments and their modifications are clearly set down, is recommended. In considering principle-oriented analyses, it is worth taking note of Diego Gracia, a prolific Spanish bioethicist, who has had enormous impact in his country and on Latin American bioethical teachings and publications. Although Gracia takes a critical stance toward Anglo-Saxon bioethics, he has developed a version of the principlist theory. His version of principlism was initially more rigid than its Anglo-Saxon counterpart, since it used a lexico-

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graphical order. Gracia later softened his position to take account of circumstances and context, and proposed that casuistry be used as a complement to his principle-oriented approach. 7 In Latin America the discussion about the correct bioethical theory continues to pervade the debate. Not only is Beauchamp and Childress’s theory of principles questioned, but other Anglo-Saxon theoretical accounts, such as utilitarianism, are often rejected. Even alternative positions that try to break the Anglo-Saxon mold are not as discordant as they would like to be. One example is Volnei Garrafa’s proposal of a “strong bioethics” that has, despite the author’s origins, a strong British utilitarian timbre, reminiscent of early utilitarianism and social reform. 8 Garrafa defends the prioritization of policies and decision making that privilege the greatest possible number of persons as being morally justifiable in the public and collective domain. These policies should be pursued even to the detriment of individual situations, although he recognizes possible exceptions. 9 Casuistry, then, can be seen as a possible replacement for, or complement to, the theory of principles or other theoretical accounts. Can this proposal really convey the particularities of the Latin American situation?

3. Casuistry: Features of the Methodology The analysis of the role and weight of casuistry should begin with a reexamination of medieval casuistry. The first version of casuistry fell into disrepute following Pascal’s critiques in the seventeenth century. However, in 1988 Albert R. Jonsen and Stephen Toulmin took it up in The Abuse of Casuistry: A History of Moral Reasoning 10 as a result of the work in the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. Created in the United States, the commission elaborated appropriate policies for the protection of research subjects. Jonsen and Toulmin draw on concrete problems to support the importance of casuistry. The emergence of bioethics, especially of medical ethics and dilemmas, once again points to the need for subtle and detailed analysis, much as the casuists did. In The Abuse of Casuistry, Jonsen and Toulmin seek to quash reservations about casuistry that have arisen since Pascal, and to show the approach’s relevance in today’s moral discourse. The authors examine medieval casuistry and moral discussions across the centuries. They study the modifications, exceptions, and relevant distinctions that casuistry helped to elaborate. In their book, Jonsen and Toulmin do not present a modernized version of casuistry, but instead retain the method and structure of medieval casuistry. They do not seem to think that the centuries that have passed justify altering in any way the theory they defend. This is why I have to speak of medieval casuistry now.

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Jonsen and Toulmin distinguish six features in casuistry: (1) paradigms and analogies; (2) maxims; (3) circumstances; (4) probability; (5) cumulative arguments; and (6) resolution. (1) Through paradigm and analogy, the authors explain that cases in the Middle Ages were presented in such a way as to show the link between a specific case and a given principle. They propose definitions of key terms and generally draw on authorities like Saint Augustine, Saint Thomas, and Cicero. Such thinkers elaborated cases illustrating the most manifest violation of a general principle, which all would agree there could be no reason not to consider as involving an offense. These paradigmatic cases enjoyed intrinsic and extrinsic certainty. Later, the cases were distanced from the paradigm, and different combinations of motives and circumstances introduced. These made an offense more or less obvious, raising questions of whether, for example, it was morally permissible to impose the death penalty; to kill a tyrant; to kill to defend your family, your property, or your honor; or to kill in self-defense. The standard procedure turned from the consideration of clear and simple cases to enigmatic and complex ones, and represented the essence of casuistry’s way of thinking. Thus, the paradigm and analogy governed the ordering of cases under a principle. 11 An attempt was made to establish a taxonomy of well-analyzed “type cases,” which would serve as an object of comparison or paradigm for new and complex cases. (2) Maxims drew on Roman law, religious authorities, and commonsense. Casuists used rules which, though general, were not universal or invariable. 12 These were said to be derived from natural law and were used as a guarantee, or as reasons for the argument. (3) Circumstances raised questions of who, what, where, why, and when. Cases were constructed with progressive difficulties incorporating increasingly complex circumstances. Casuists insisted that the circumstances were what constituted the case, and inevitably modified the moral judgment of it. (4) Probability categorized cases by the likelihood of their conclusions. Moral choices were seen as more or less arguable. The further away they moved from the paradigmatic case, the more debatable they became. No reference was made to necessary or apodictic conclusions. A stronger or weaker conviction was determined by intrinsic reasoning and extrinsic authorities. Certainty did not exist. (5) Cumulative arguments. High casuistry cited maxims and short arguments to support conclusions (a scriptural text, canon law, an appeal to charity or to justice). Hardly any effort was made to integrate these elements into one coherent argument. Correlations exist with common sense and rhetorical discourse. In fact, casuistry defends this line of argumentation against the geometric view of moral reasoning. This latter view consists of the logical derivation of conclusions through the use of basic general principles, and its classic advocate was Baruch Spinoza in Ethics Geometrically Represented.

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(6) Resolution. Casuists always concluded their analysis of a case with a resolution. The objective of moral science was practice. Any conclusion that was not practical but merely speculative was not considered a moral conclusion. 13 It was with this in mind that the casuists tried to reach a decision and a course of action. The need to interpret maxims in different circumstances made casuists sensitive toward and perceptive of differences between cases. For casuistry, perceptiveness is a virtue. Casuistry has ties with the Aristotelian tradition of practical reasoning, in so far as it stresses the capacity for recognizing and detailing the relevant features of a particular case and determining its weight. Aristotelian phronesis makes it possible to judge the correlation between a specific case and the paradigm. Doing this does not involve an appeal to general rules or valid deductions. Rules and maxims are formulated, but limited. Jonsen, more recently, has explained casuistry with the use of a simile, appealing to the image of the memory palace. The image was used as a teaching tool for centuries. The casuistical process runs as follows. First, we have to identify the “topics,” a notion from old rhetoric. Topics were kinds of arguments that served for persuasive discourse, in general, or for a concrete undertaking, in particular. Rhetoric conceived of them as mental places or spaces. 14 Jonsen suggests that there are four specific topics in clinical medicine: medical indications, the patient’s preferences, the quality of life, and contextual features. 15 Second comes the description and evaluation of the circumstances, which was considered the furniture and decoration of the rooms in the memory palace. These are not isolated facts, but facts in the topic (much like the knickknacks in a room). The questions here are who, what, where, why, and when the case took place. Finally comes the comparison of cases, in which casuistry looks for similarities with other cases and uses reasoning by analogy.

4. Functions of the Case Cases have an important bearing in casuistry. However, “case” is hardly tantamount to “casuistry.” Do Jonsen and Toulmin consider that case and casuistry still hold a position of importance in today’s moral reflection? What are the possible functions of the use of cases? Before answering these questions, consider some of the roles that cases in general can play: (1) Motivational function. The objective of the use of the case is to persuade us to do our duty: cases stimulate our imagination and our passions in a way that moral rules and reasoning cannot. It should be born in mind that, as a motivator, the case is only a means to move us to act according to the duties and principles that have already been previously determined. Kant, for example, draws on this function in his Groundwork of the Metaphysics of Morals.

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The philosopher Charles Larmore has provided some interesting insights into examples in moral experience. In Patterns of Moral Complexity, 16 Larmore describes the motivational use of examples and labels it rhetorical. Since Jonsen and Toulmin use the term “rhetorical” to characterize moral casuistical reasoning, I prefer to call this function “motivational.” On the other hand, I do not follow Larmore’s proposal strictly. I distinguish between the “motivational” and “explanatory” use of examples or cases, while he does not. (2) Explanatory example function. With this function, the case assumes a secondary role. It is used to show how applicable some rules or moral principles can be. Larmore refers to Kant as the advocate of this use of examples in the Groundwork of the Metaphysics of Morals. Larmore explains that Kant’s conception is complex, and maintains that Kant was right in considering the example as extrinsic to the structure of moral duty itself: Every example of morality presented to me must first itself be judged by moral principles in order to decide if it is fit to serve as an original example. 17 Larmore continues: Hence, not only do examples thus conceived have nothing to do with ascertaining what our duties are, but our choice of the examples amounts to no more than applying the rules contained in the concept of those duties. 18 (3) Intrinsic distinctive function: Larmore distinguishes between applying rules and acting on reasons that imply previously undetermined rules. This function of the example does not consist in the application of rules, be they implicit or explicit. Implicit rules are previously determined. But, because of their being “implicit” they do not figure in the agent’s awareness. 19 Larmore criticizes the view that considers reasons are reasons by virtue of some rule. He highlights the importance of deliberation and of the particular circumstance. However, he does not deny that rules are a necessary feature of morality. For Larmore, the distinction between implicit and explicit rules is essential to understanding how moral judgment responds to the particularity of the situation, and goes beyond the content given by a schematic rule. An example, he says, can function as a reason and can exemplify the exercise of moral judgment and of moral deliberation. It has an active and intrinsic role that helps give content to schematic rules and exemplifies moral deliberation. Nevertheless, Larmore is not very clear about his own position on cases. He appears to privilege moral deliberation when applying general rules, and to privilege schematic rules when deciding what duties have to be honored and what actions will satisfy them. He suggests that the case can exemplify the process and can act as a source of reasons for relating moral deliberation to moral rules.

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(4) Consensual function. The case, viewed as a point of concurrence before theoretical dissidences, principles, or different moral rules, was effectively used by the National Commission in the United States to elaborate guidelines for the protection of human subjects. Jonsen explains his work in the Commission: The members of the commission soon discovered a singular fact: they often had serious discrepancies over the formulation of principles while they quickly reached agreements over particular cases. The Report on Children as Research Subjects is, in my opinion, an excellent example of modern casuistry. The commission’s success, I believe, came from its attention to concrete cases in which principles were discovered as well as applied. The Belmont Report, which establishes the principles of the research, only arrived at the end of the project. 20 The preceding review is not comprehensive. It presents the main roles that cases can play and shows how those roles imply a special form of exploring the theoretical problems of ethics, epistemology, and metaphysics.

5. Interpretations of Casuistry What roles do Jonsen and Toulmin give to cases and principles or rules in casuistry? They appear to oscillate between different claims. First, they leave aside the explanatory example function as it supposes that the case has only a secondary and extrinsic function. In casuistry the case is not subordinated to the rule. Its function is intrinsic in every situation. With respect to the other functions, it is necessary to clarify what Jonsen and Toulmin try to achieve. The authors fluctuate between two claims: one weak and the other strong. The weak claim holds that casuistry complements other ethical analyses. They acknowledge the importance of other forms of analysis that use principles or other kinds of generalizations. In its defense, they explain that moral theories operate on several levels. In distinct contexts, different arguments have greater power to convince, different chances of acceptance, and can constitute different sources of moral action. For example, in one of the last chapters of the Abuse of Casuistry, Jonsen and Toulmin indicate that the primary aim of the book is to counter the general disregard of cases as a fruitful method of practical moral reasoning. 21 According to Jonsen and Toulmin’s weak claim, at least two of the abovementioned roles for cases seem to apply: the motivational function and the intrinsic distinctive function. Regarding the motivational role, the authors could not subscribe to an extrinsic character, which still prevails in the description in the previous section. As to the intrinsic distinctive function, Jonsen and Toulmin appear to accept the legitimacy of principles and general rules, although

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cases take a leading and more active role. This, in turn, is compatible with moral deliberation and the validation of the Aristotelian method Larmore also endorses. However, Jonsen and Toulmin also recognize an ambiguity in their formulations, and clearly wonder to what extent the new casuistry contradicts the traditional view of moral practice that applies universal principles of ethical theory to particular cases. While maintaining that casuistry should be emphasized, they clearly consider it too weak a conclusion. They try to say something more substantial. The second conclusion, or the strong claim, holds that moral knowledge is fundamentally particular, so that sound resolutions of moral problems must always be rooted in a concrete understanding of specific cases and circumstances. 22 They refer to John Arras. 23 Instead of focusing on the need to fit principles to cases, this >second and strong@ interpretation >of casuistry@ stresses the particular nature, derivation, and function of the principles manipulated by the new casuists. Through this alternative theory of principles, we begin to discern a morality that develops, not from top down as in Roman law, but rather case by case (or from the bottom up) as in the common law. What differentiates the new casuistry from applied ethics, then, is not the recognition that principles must eventually be applied, but rather a particular account of the logic and derivation of the principles that we deploy in moral discourse. 24 The prime locus of moral understanding lies in the acknowledgement of paradigmatic examples of good and evil, and of right and wrong. In this strong position, the core of moral knowledge is not found by accepting universal propositions like “cruelty is wrong,” since cruelty is a basic “wrong,” but by being able to see that moral knowledge can be morally crucial in difficult situations. This capability is not the “cognitive skill” of learning to make increasingly more powerful ethical deductions. It is about our affective sensibility: learning what new factors and circumstances to look for, and learning to respond to the range of moral experiences. 25 Note the difference between the two conceptions of the case and its function in moral theory. While the weak proposal of casuistry attempts to revalue or elevate consideration of the case in moral argument, the strong one seems to privilege the case as a guiding element in moral life, leaving aside the importance of principles or rules. These two underlying conceptions are particularly relevant because they imply a divide in moral theory and because the second can serve as an alternative moral theory to theories based on principles. However, can this extreme version of casuistry be maintained? It seems that the strong version of casuistry, and its account of the central role of the case, is too severe. The strong position could be interpreted in two ways, each

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of which has different implications: (1) it could imply that principles do not exist and that specific knowledge is all that matters; and, (2) it could be seen as a critique of geometric moral theory that logically derives conclusions from principles. The first interpretation, (1), goes beyond the role of cases described earlier. Elements of it can be present in the intrinsic distinctive function, but it appears to go further by regarding principles or general rules as wholly irrelevant. Not even the consensual function is viable under this interpretation, since the interpretation would appear to deny the possibility of principles in favor of an exclusive focus on cases. Despite the ambiguity and the haste with which the strong position is formulated, only the second interpretation, (2), is viable. This latter interpretation denies not general rules and principles, but only the strategy stating that moral conclusions can be logically deduced from such rules or principles. Within this line of reasoning it makes sense to appeal to perception and to cumulative arguments. It can be explained as a strong critique of interpreting ethics as a deductive or geometric system. This is not a rejection of the existence of principles, but of the characterization of the relationship between case and principle as one of logical deduction. The first interpretation of the strong position goes beyond traditional casuistry. High casuistry attempted to avoid charges of relativism by advancing an entire body of knowledge: authorities, maxims, and revealed truths. There was a shared “worldview.” Firm criteria could be expressed in principles and general rules. These are the elements that a contemporary application of casuistry lacks. Thus, the new casuistry is left without a substantial base and becomes vulnerable to diverse critiques. It can be objected too on grounds of conventionalism, or the danger of falling into prejudicial analysis. 26 One of contemporary casuistry’s major problems is that, nowadays, pluralistic societies cannot assume a shared body of values and a shared worldview. The Middle Ages, on the contrary, could lay claim to just such a shared worldview and system of a common moral dogma. Without a shared worldview, principles can best give coherence to ethical thinking. As a result, the new casuistry cannot deny the existence of principles or of more or less general rules. Despite the fact that the strong position seems compelled to accept maxims or rules, Gracia’s analysis in Procedimientos de Decisión en Etica Clínica is not entirely accurate. 27 Gracia underlines the importance of maxims in casuistry. Yet, over-emphasis on maxims leads to the role of cases being disregarded, and cases are crucial to casuistry. Undoubtedly, this discrepancy in our positions once again reveals the ambiguity of the theory and the diversity of criteria that arises in its interpretation. Thus, the first weak position portrays casuistry as revaluing the importance of the case in moral argumentation, and the second position (in its second interpretation) presents the approach as criticizing the deductive strategy. Accepting the strong interpretation of the second claim implies going beyond

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what the casuists themselves claimed. Casuistry involves an acceptance of principles, general rules, and maxims. Yet, a discrepancy does exist in the stances adopted by the authors of this view. Toulmin holds a more extreme interpretation, while Jonsen takes a more conciliatory vein. The differences between the authors themselves probably explains the ambiguity and the coexistence of the two versions of casuistry.

6. Conclusion Despite attempts to present casuistry as the alternative to more popular bioethical approaches, casuistry can work, at most, as a complementary method. In a recently published article, Jonsen argues: 28 It should be clear that this casuist, at least, considers casuistry to be complementary to principles. The task of working out exactly what the complement is belongs to moral philosophy (and moral philosophers have been working at it for centuries). The value of casuistry lies in its effort to appreciate more fully the way in which circumstances play an intrinsic role in moral judgment and in its attempt to provide to the one making a judgment a sort of “guided tour” through the complexity of circumstances. It is my opinion that moral philosophy, as it has been done in recent times provides little guidance through cases. 29 In the same article, Jonsen proposes a metaphor that places casuistry in a complementary position. He states: The moral philosopher may be the architect of the moral “memory palace” but the casuist is its interior decorator. The palace, constructed of theory and principles, is empty without the interior design, finishing, and furniture of circumstance. These do not merely stand around as neutral items, but are intrinsic features of the edifice, without which interpretation and appreciation are impossible. 30 Whether Jonsen has chosen a good metaphor is questionable. Interior design, details, and furnishings are not intrinsic features of a building. Yet, it is clear that for Jonsen the re-emergence of casuistry does not have the strength initially claimed for it. Its attempt to be a rival and unique moral theory is not viable, while rescuing the case in moral deliberation from disrepute and scorn is. The analysis of cases, their functions, and possible interpretations support this view. In this sense, casuistry shows the relevance of context. It can show the impact that gender has in particular cases, and how exclusion and vulnerability are present in Latin American cases. It may be an interesting tool to use once a rational dialogue regarding abortion is achieved—as we will see in

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Chapter Four—allowing continuation of the discussion by analyzing justifiable cases for abortion. Casuistry can work in bioethics, but only within the limited interpretations mentioned above. Only with these caveats will it be a useful tool. Ethical principles need a context. In its limited fashion, casuistry can be a complementary analysis that tries to acknowledge the diversity of other societies and cultures. However, principles may not be sufficient to uncover and explain non-ideal situations that Latin America faces. Other theoretical accounts will be suggested in the “Afterthoughts” of this book such as substantive theories of justice and human rights considerations, among others.

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Three RESPECT FOR PERSONS AND THE ILLITERATE 1. Introduction This chapter examines paternalism, its roots, and manifestations, within the framework of the physician-patient relationship. A widespread problem in most Latin American countries is lack of respect for persons. Paternalism has often been presented as justified in the case of the illiterate. Their being illiterate appears to justify a model that disregards the patients’ values, the patients’ autonomy, and their right to access to information. The justification falls back on a commonly accepted argument. The illiterate are uneducated; they lack information; and they lack the ability to understand the information they are given. Their inability to make decisions thus warrants the adoption of a paternalistic attitude toward them. That the illiterate ought not to be autonomous justifies an a priori attitude: as it is difficult to communicate with them, the physician decides what treatment the illiterate patient is to follow. Let us call this “the illiteracy argument.” The argument justifies an a priori attitude based not on experience but on decisions taken without a prior analysis of the facts. This chapter examines the implications of this attitude, as well as the problems with the illiteracy argument. The reasoning for the illiteracy argument combines facts—the number of illiterate patients in particular countries—with moral values. Its strength lies in the consideration of a concrete and grave situation. It speaks out against the principle of autonomy, which is deemed foreign and inapplicable to the social reality of these countries. Despite the popularity of the argument, Argentina does not have a very high illiteracy rate. A comparison of the 1980 and 1991 census data shows that the net educational base at the primary level grew from 90.55 percent to 95.69 percent, and that middle education went from 41.85 to 59.24 percent. The 2001 census showed 767,027 illiterates from 29,400,000 persons older than ten years. According to UNICEF’s (United Nations Children’s Fund) demographic and health reports in Argentina, Mexico, China, and Korea, the male literacy rate is 87 percent while the female rate is 80 percent. In Turkey, South Africa, Guatemala, and Indonesia it totals 69 percent and 49 percent. In Mozambique, Ethiopia, India, and Bangladesh it is 43 percent and 22 percent. In the Argentine case, an atypical patient is used as a parameter for treatment of all patients. Less than 3 percent of the patients are taken as the norm. This is wrong and unfair.

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Even though the argument is popular in Argentina and in countries with a relatively low illiteracy rate, it is also applied in countries where illiteracy is much more common. However, in countries where the argument could justifiably be applied, the second and fundamental point is its incorrect conclusion: an a priori attitude. As mentioned, the argument favoring a paternalistic treatment of the illiterate is widespread in countries like Argentina, although not all physicians act paternalistically. Bioethical teachings have slowly begun to build an awareness of these problems. Informed consent is gradually being introduced. However, it is mostly applied in private settings, or when using highly sophisticated techniques such as assisted reproduction or plastic surgery. All too often its intended function is to protect the physician. It is not offered in order to explain the nature of medical interventions, or out of respect for the patient. The patient is generally given a blank form to sign prior to tests or admission to a clinic. Given the non-critical acceptance of the illiteracy argument in the region, this chapter examines it thoroughly. First, it defines illiteracy. Second, it examines the concept of paternalism and the idea of competence to see what these notions imply and whether some of the interpretations can, in fact, justify an a priori attitude. Finally, it will consider what interpretations we can draw from the argument, their implications, and the conclusions.

2. The Problem of Illiteracy An illiterate person is generally believed to be someone who can neither read nor write. These are individuals who have never attended primary school or who dropped out. They lack the “education” obtained from traditional institutions. We will refer to the illiterate as persons that may not know how to read or to write correctly but that share and speak the country’s language. The cases of people that do speak and share another culture, but do not read or write in the local language go beyond this chapter. A major conceptual distinction is currently made between the illiterate and the functionally illiterate. The functionally illiterate are persons that, having initially learned basic reading and writing skills, cannot apply them because they dropped out of school early and have lost the ability to read. Illiterate individuals differ. They may live in remote rural areas or urban centers offering untold stimuli. They must adapt to city life and use, for example, public transportation services. At the same time, we can no longer speak of absolute illiteracy because of the media’s influence (via television, radio, or cinema). The media do inform and do connect these persons to other realities and situations, which would otherwise be totally foreign to them. For the purposes of this chapter, all of these cases are counted as cases of illiteracy.

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3. Paternalism and Competence The field of bioethics has defined paternalism in diverse ways. Some focus on constrained freedom. Gerald Dworkin describes paternalism as: […] roughly, the interference with a person’s liberty of action justified by reasons referring exclusively to the welfare, good, happiness, needs, interests, or values of the person being coerced. 1 Others maintain that paternalistic behavior violates a right or moral rule. 2 James Childress proposes: Paternalistic action is non-acquiescence in a person’s wishes, choices, and actions for that person’s own benefit. 3 Paternalism assumes that the motives and intentions of the paternalistic provider are benevolent; and, that the paternalistic provider makes all or some of the decisions instead of allowing the patient to decide. Different kinds of paternalism exist. Limited or restricted paternalism overrides a person’s wishes and choices for the person’s own good when the patient suffers from some defect, encumbrance, or limitation that hampers decision making. One example is that of overriding a patient’s refusal to accept life-saving medical treatment because long-term drug use prevents the patient from making a decision. James F. Childress comments that few people deny that restricted paternalism is morally acceptable and even obligatory in some cases. 4 Extended or extreme paternalism protects the individual who does not suffer from severe defects, encumbrances, or limitations in decision making. It overrides a person’s wishes and choices because they are risky for that person. One example is forcing a competent adult Jehovah’s Witness to accept a blood transfusion. Richard Arneson makes a similar distinction. Soft paternalism is the doctrine that paternalism can only be justifiable when the individual choice that is restricted fails to be substantially voluntary. It fails to meet a threshold of voluntariness. Hard paternalism holds that paternalism can be justifiable even if the individual action that is restricted is substantially voluntarily chosen. 5 When is paternalism justified? Childress, for example, speaks of two conditions that would justify it for medical purposes: (1) defects, encumbrances, and limitations of a person’s decision-making and action; and (2) probability of harm to the patient unless there is intervention. Holding the second condition (probability of harm) implies an expanded or strong paternalism as it disregards the patient’s desires, volition, and competence. Instead, maintaining that both conditions are necessary justifies only a weak or limited paternalism. 6

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Joel Feinberg, Jeffrie Murphy, and John D. Hodson also defend weak paternalism. Feinberg concentrates on “non-voluntariness,” 7 Murphy on “incompetence,” 8 and Hodson on “encumbrances.” 9 While no dispute exists about whether extended paternalism is really “paternalism,” a great dispute exists about whether it can ever be justified. To intervene merely because a person suffers from some defect, problem, or limitation in decision-making or in acting is unwarranted. This is intervention for the sake of intervention. As “paternalism” implies, intervention must be justified in terms of the patient’s interests, as well as in terms of the patient’s problems in deciding or acting. Both conditions are necessary. For Childress, the principles of beneficence and respect for persons (autonomy) can only be upheld with weak paternalism. Consider some key points in the notion of competence. Condition (1) justifying paternalism is related to the idea of competence insofar as it is concerned with decision-making ability. Allen Buchanan and Dan Brock characterize “competence” in the field of bioethics as follows: Competence is always competence for some task — competence to do something […] hence; competence is to be understood as decision-making capacity. 10 As mentioned, some situations clearly justify paternalism and even call for it. This is the case with incompetent patients, those without the power of decision—the newborn, young children, and adults in a permanent vegetative state. Establishing a person’s decision-making competence is not always straightforward. To that end, a physician must examine some of the patient’s capabilities (comprehension and communication, reasoning, and deliberation). An evaluation should be made to determine whether the person has a set of values or conceptions of what is good, and whether other factors can interfere that impede or diminish competence (for example, an emotional block). Note that competence can vary over time and can also be sporadic. Another question regarding competence is linked to informed consent. Competence expressed in the decision-making process is one of the three necessary elements (together with information and the absence of coercion) considered when analyzing informed consent. Individuals are judged on their competence to make particular decisions, even if they may not be in full control of their capabilities. In this sense, the concept of competence acts as a threshold. Still, even when Buchanan and Brock use this sense of the term, they say that the wishes of an “almost competent” patient, a patient who falls just short of the threshold of competence, must be weighed when a treatment is formulated. 11 Finally, all adults generally share a global competence. That is, adults have sufficient capability to decide for themselves. 12 This is overlooked by the

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pro-paternalistic argument analyzed here. The underlying notion in the argument claims that these individuals are not competent or, at least, that the illiterate do not enjoy this global competence. The argument does not consider the illiterate to be competent persons. Hence, it supposedly implies some form of justified paternalism. In light of the concept of competence set out above, what does this argument imply regarding the illiterate?

4. Interpretations of the Illiteracy Argument A. The Incompetent Illiterate One interpretation deems the illiterate to be incompetent, that is, persons with whom communication is impossible. Yet, is this concept fair to illiterate adults? It appears to be too strong a statement. It denies them the opportunity to communicate and denies them relevant values. It reduces them to the equivalent of a coma victim or a newborn child. Unfounded as this interpretation may be, it is one of the strong underlying arguments used to support paternalism. No attempt is made to communicate with the illiterate or to try to understand their values or preferences. These persons are treated as if they had serious communication problems and lacked pertinent values. If this interpretation is satisfactory, then an a priori attitude justifies considering the illiterate as incompetent individuals. However, we can see at a glance that this image of the illiterate person and its implications wrongfully underestimate the patient. The position reveals prejudices and intolerable considerations. We must disregard this interpretation and the attitude it conveys. B. Confusion between Capabilities and their Contents A second interpretation maintains that an illiterate person lacks some of the established characteristics to be considered competent. It does not say a priori that the person is incompetent, but it sets a strong presumption. In such cases, an analysis can verify whether problems hinder the necessary skills for competence. As Buchanan and Brock suggest, three conditions must be taken into consideration: (1) comprehension and communication; (2) the ability to reason and to deliberate; and (3) a set of values or conceptions of what is right. The first two conditions represent capabilities that allow individuals to be informed and to express their choice of treatment. A common error often arises: information is mistaken for comprehension. Comprehension is an ability, while information is the content obtained through this ability. The absence of a systematic education does not imply that the faculties of an illiterate person do not function. This mistake appears in the second interpretation. It ignores the differences between comprehension and information.

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An analogy with the literate patient illustrates the fallacy of the above interpretation. Literate and illiterate patients lack information or lack knowledge about, for example, their illnesses; the functioning of their bodies, glands, and organs; and the mechanisms of the medical techniques to be used. In either case the physician must provide highly detailed information. The patients must be able to understand and to appreciate the information; they must be able to reason. Yet, both lack the relevant information or knowledge which is indispensable to literate and illiterate patients. Therefore, if the abilities to comprehend, to reason, and to deliberate function correctly, the information can be acquired. And this holds for the illiterate patient, as well as for the literate patient. The illiterate patient may have trouble grasping technical terms. Physicians may have to explain different treatments more slowly and more carefully. But the illiterate are certainly not patients with mental handicaps. They themselves can appreciate and evaluate the nature and significance of treatments if they are aptly explained. The ability to evaluate the impact and the consequences of a particular therapy on their lives is fundamental. No surrogate can replace the concerned patient. Finally, consider Buchanan and Brock’s third condition for competence: a set of values and conceptions of what is right. In no way can we say that an illiterate person does not hold individual values or preferences. Denying them the opportunity to evaluate circumstances implies denying them what is fundamental to the human being. If these three conditions are basic to an individual’s decision-making faculties, then, under ordinary conditions, illiterate patients meet the conditions. Therefore, this second interpretation cannot warrant an a priori paternalistic attitude. Only a physician’s failure to distinguish abilities from information explains this attitude. Making an a priori decision about an illiterate adult’s incompetence is unfounded because we must have recourse to experience before making an evaluation. Only the firm belief that the illiterate share the level of capability of the newborn or the coma victim justifies, independently of experience, their incompetent status—and this belief is groundless and false. C. Fears, Blocks, and Compulsions A third interpretation says that illiterate patients can be deemed competent under normal circumstances, though difficulties may affect their faculties. Psychological disorders, fears, blocks, mental illnesses, compulsions, or addictions can hamper comprehension and communication. The patient might hold other values or other religious beliefs. This is true for literate patients as well. It is valid to question the person’s competence in all cases involving difficulties or problems in comprehension or communication. However, unlike the a priori attitude, this implies an a posteriori attitude. The physician does not question the patient’s competence based on illiteracy,

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but on additional factors that apparently annul the patient’s decision making. This attitude is acceptable and morally justifiable. The attitudes previously considered are biased and belittle illiterate individuals.

5. Sociological Problems and Intolerance There is another problem behind an a priori attitude. It is easier to declare that illiterate patients are incompetent and not have to determine whether they actually are. Likewise, it is more expedient to prescribe a treatment than to explain it thoroughly while bearing in mind the patient’s preferences and motivations. Illiterate patients demand more time-consuming explanations and efforts to translate medical terminology into simpler and clearer language. This involves added time and the extra effort that illiterate patients can ill afford. Illiterate patients, society’s deprived, are generally patients with few material resources. They are poor and vulnerable. This is why the pro-paternalistic attitude is prevalent in public hospitals or in public health-care systems. Those who can afford a private physician tend to be better educated. This creates a dimension of unfairness and discrimination that is implicit in the argument. It reveals sociological and economic constraints. However, no matter how relevant the sociological and economic problems may be, they cannot justify denying the illiterate competence. No ethical justification exists. Not even weak or restricted paternalism can justify the illiteracy argument. Not only do the illiterate not lack competence per se, but it should also be demonstrated that the patient is at risk. Why is this argument so popular? Perhaps part of the answer lies in the “traditional” attitude of some physicians, fostered by what Diego Gracia, the Spanish bioethicist, calls a “virtue” in the Latin context: intolerance. In “Hard Times, Hard Choices: Founding Bioethics Today,” 13 Gracia says “Latin people are profoundly uncomfortable with rights and principles and prefer virtues to rights.” 14 In a highly significant paragraph, he refers to the intolerant aspect of the Latin culture: Seeking virtue and excellence, Latin countries have traditionally been very intolerant. Tolerance was not included as a virtue in the old catalogue of Latin ethics. The real virtue was intolerance, and tolerance was considered a vice. That was the original [element] of the continuous religious wars in our [Spanish] history, of the Inquisition, etc. Tolerance as a virtue was conceived of by Anglo-Saxons in the seventeenth century. 15 Some people may find this comment troubling. However, Gracia is right in pointing out that paternalism and intolerance are traditional defects of our moral life.

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Tolerance means accepting and respecting other views, even if they differ from “our view,” or the educated view. Treating illiterate patients as incompetent persons and denying them their decision-making rights disregards their values and autonomy. It is an intolerant and authoritarian attitude. Latin societies may have considered intolerance a virtue, which might explain why it is so difficult to eradicate this attitude. We should re-think that view and build a new model rooted in tolerance and respect for persons. Traditions do not offer ethical justifications. The “intolerance tradition” is highly problematic and cannot be endorsed.

6. Conclusion With respect to the illiteracy argument, only the first interpretation that considers the illiterate incompetent justifies an a priori attitude. However, this implies assuming an erroneous and unfair position toward the illiterate, and is, therefore, unacceptable. The second and third interpretations show that we cannot assume an a priori attitude, and that the paternalistic argument as such does not hold. The second interpretation tries to show that the lack of information and the inability to communicate or understand are often confused. The third interpretation, which refers to internal obstacles such as compulsions, explains that an a posteriori attitude is legitimate when signs of other problems that can hamper competence prevail (for example, psychological blocks or fear). If this holds, a change in attitude toward the illiterate is indispensable. First, we should reject the a priori attitude that denies patients their chance to participate. Second, we should assume that patients are competent and merit a non-paternalistic relationship (informing and listening to the patient). Third, we can only adopt an a posteriori paternalistic attitude if additional factors annul or hinder the patient’s faculty to make decisions. And that is all. The argument cannot endorse the pro-paternalistic view. The a priori attitude is unjustifiable and the illiteracy argument is far weaker than it claims to be. Countries with high illiteracy rates need not fall into a non-critical paternalism. A detailed analysis shows that only the third interpretation is justified, and proposes a change in attitude toward the illiterate patient. Impediments, blocks, or problems can impact on the competence of persons who find themselves in the vulnerable situation of patient. The physician must be alert and must carefully examine each patient’s situation. This far from justifies an a priori paternalistic attitude for all cases, as, in fact, it assumes. These attitudes embrace authoritarian, paternalistic, and intolerant elements toward the most vulnerable patients—toward those who can neither read nor write (universally affecting more women than men). The following chapters examine similar attitudes with respect to women, and will address issues that especially concern them, such as reproductive rights and abortion.

Four INTERNAL REASONS AND ABORTION 1. Introduction It is common knowledge that abortion is a crime and is penalized in most Latin American societies. The region suffers from an extreme intolerance of abortion, and the chances of the practice being legalized are extremely remote. This does not mean that abortions are not carried out. Latin American societies continue to exercise a “double moral standard.” A huge gap exists between official discourse and what actually happens. An examination of the situation shows sharp contradictions in the literature, in the laws, among decision-makers, and actual practice. Restrictive laws and the conservative interpretation that judges and physicians make of them contrast widely with the staggering number of illegal abortions. It is estimated that more than 500,000 abortions are performed in Argentina annually, a ratio of one abortion for every two births. Women risk their lives and health to undergo abortions. An estimated forty percent of the patients in gynecological and obstetric wards are hospitalized because of complications from illegal abortions. In Argentina, illegal abortions are the main cause of maternal mortality. The same applies to Ecuador and Paraguay. In Peru and Colombia abortions constitute the second most frequent cause of maternal mortality, while in Bolivia, Brazil, and Panama they are the third most frequent. 1 Keeping in mind local attitudes, this chapter deals with the challenge implied in considering abortion from the Southern perspective. It works within the limits of the conceptual scheme accepted in the region, and tries to build a dialogue within this narrow framework. The chapter is based on Argentina’s highly restrictive legislation. Exceptions built into the legislation—such as the allowance of abortion to prevent a danger to the woman´s life or health—are considered to be just and impartial. Positions that deny these minimal exceptions take an extremist stance that precludes any possibility of rational dialogue. Extreme or radical attitudes hinder common discourse. Penalizing abortion for an adolescent rape victim or a mentally handicapped person does not stand up to rational or humanitarian analysis. This chapter defends the construction of a minimum base for rational agreement. It leaves aside broader proposals, and tries to find a common ground between two opposing positions. The chapter considers theoretical and philosophical issues. It tries to explain the sterility of the classic controversy over abortion. To this end, it will analyze and try to clarify elements of a theoretical nature, such as Bernard Williams’s notion of internal reasons.

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The topic of this chapter can be read from different perspectives. The first implies playing with two different levels of theory. It attempts to apply the theoretical construction of the explanation of actions to a concrete theoretical problem like the abortion discussion. A second perspective considers the application of the previous theoretical approach to the abortion issue. It tries to provide a clear answer to how we should act, implement, or virtually resolve the abortion problem. Another possible and interesting view of the abortion issue involves the adoption of a legal and sociological perspective. It poses the problem of legalizing abortion and the prevailing sociological problems in Argentina (such as, the number of illegal abortions, the conditions under which they are carried out, the percentage of deaths, and the implications for women). The philosophical question is left aside in an attempt to solve the sociological problem. Even though the second and third perspectives are quite important, they go beyond the chapter. In meeting the challenge of working within such a restrictive legal framework, the chapter examines the first perspective—the theoretical approach that is applied to the abortion discussion. The chapter examines the distinction between internal and external reasons that the philosopher Bernard Williams discusses, 2 with the aim of exploring how this distinction can be applied to a still unresolved problem in bioethics: the moral justification of abortion. It tries to show how Williams’s proposal helps us view the abortion discussion from a different perspective. By applying the notion of internal reasons, we can achieve a better point of departure toward solving the problem. The chapter explains how this distinction can be employed and how the conception of internal reasons can help in the discussion. The chapter first describes the distinction between internal and external reasons. After an analysis of the classic discussion of abortion in light of external reasons, it considers a different approach to the debate based on the strategy of internal reasons. If this proves to be a fitting interpretation and application of the distinction between internal and external reasons, then, the analysis based on internal reasons is a promising way to tackle the problem of abortion.

2. Williams on Internal and External Reasons In “Internal and External Reasons,” Williams introduces the distinction between internal reasons and external reasons as two different ways of interpreting reasons for actions. Williams speaks of two different possible interpretations of “A has a reason to )” (where A is some agent, and ) represents some verb of action). The internal interpretation considers that there is a motivation; there is a condition that is related to the agent’s objectives. If this is not satisfied, we cannot say

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that A has a reason to ). Therefore, the truth of the sentence “A has a reason to x” implies that A has a motivation that will be satisfied by action x. In the external interpretation, no such condition exists, and the sentence that explains the reason will not be false without the appropriate motivation. When Williams analyzes the “internal” interpretation, he says that it must display a relativity of the reason statement to the agent’s subjective motivational set. Williams characterizes the motivational set as being made up of desires, aptitude for evaluation, schemes of emotional reaction, personal loyalties, and the different projects that make up the agent’s commitments. This motivational set is not static. The deliberative process can have all kinds of effects on it. 3 External reason statements, by contrast, are taken to be capable of truth independently of the agent’s motivations. But nothing can explain the agent’s intended actions unless something motivates him or her to act. Thus, says Williams, we require something more than the true belief of the external reason statement to explain the action. By way of illustration, Williams tells the story of Owen Wingrave. Owen’s family urge on him the necessity and importance of his joining the army since all his male ancestors were soldiers, and family pride requires him to do the same. Owen has no motivation to join the army at all, and all his desires lead him in another direction: he hates everything about military life and what it means. His family might have expressed themselves by saying that there is a reason for Owen to join the army. This reason appears to be an external reason, because there is nothing in Owen’s subjective motivational set that would lead to this through deliberative reasoning. The external reason statements cannot be part of the motivational set unless they are adopted as true beliefs. If Owen Wingrave comes to join the army because (now) he believes that it is a reason for him to do so that his family has a tradition of military honor, Williams will claim that he now has a disposition to action, sentiment, and so forth. Finally, Williams says that external reason statements when definitely isolated as such are false, or incoherent, or misleadingly expressed. Those who use these words often seem, rather, to be entertaining an optimistic internal reason claim, but sometimes the statement is indeed offered as standing definitely outside the agent’s S [that is, outside the agent’s motivational set] and what he might derive from it in rational deliberation, and then there is, I suggest, a great unclarity about what is meant. 4 With the aim of rectifying the difficulty in the meaning and maintaining the dichotomy between internal and external reasons, consider a Kantian reading of external reasons. Kant thinks that moral reasons are independent of what people happen to want. We must be careful, though, in using the analogy with Kant, because Williams clarifies that external reason statements do not

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necessarily relate to morality. However, even though Kant does not equate “desires” and “motivations,” Williams has a strong tendency to identify motivations with desires. In this sense, we can consider Kantian moral reasons to be independent of “internal reasons.” Even if I do not totally adhere to Williams’s theoretical proposal in his critique of abstract morality and in his prioritization of other values over morality, as in his book Ethics and the Limits of Philosophy, 5 the idea of internal reasons presented in Moral Luck is an interesting theoretical mechanism. In Kant, reason is presented in a purely objective way. If reason dictates that we should fight for the honor of the family, there is a reason to do so. Kant’s vision is somehow objective and intuitive. It is similar to the case of a mother telling her child there are good reasons to do x, even though the child does not believe her or disagrees.

3. External Reasons and Abortion Williams does not show ways to employ this distinction between internal and external reasons other than by the example of Owen Wingrave. However, the distinction is an interesting tool to solve some conflicts and help place old controversies in another light. Let us use it in a broader sense, not merely referring to relationships with individual agents, but to the internal and external reasons of groups or sets of individuals who share a common “motivational set.” A major issue in the traditional debate on abortion is that of the moral status of the fetus, that is, whether the fetus is or is not a person. We have to establish whether the entity that results from the fertilization of an oocyte by a human sperm is subject to rights at some point in its development. What is at stake is the right to life. The question is determining when a particular entity starts to be a person and how we define persons. If embryos or fetuses are “persons” then they have rights, such as the right to life. The analysis of the moral status of the fetus has divided those who defend and attack abortion into two irreconcilable positions: a person’s life starts at conception, and so, an embryo has rights (John T. Noonan) 6 ; and life begins at birth or afterwards (Mary Ann Warren). 7 According to Warren, the fetus does not possess the relevant features to be considered a “person.” She offers a list of criteria to define what it is to be a person: (1) consciousness and the ability to feel pain; (2) the ability to reason (the ability to resolve new and relatively complicated problems); (3) the ability to act in ways that go beyond instinct; (4) the faculty for complex communication; and, (5) having a sense of self. Both positions find the opposing lines of reasoning unacceptable. They offer reasons that do not form part of the other’s core of beliefs. In some cases, these positions are a matter of “intuitions” rather than “reasons,” and are not

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based on any serious line of reasoning. Many philosophers suggest that the positions are not only emotionally tinged, but are rooted in strong religious conceptions. They mention the difficulty in achieving a rational dialogue between the opposing camps. 8 Remember that the possibility of making relevant distinctions between what a “person” is or is not during the fetal development process appears to be arbitrary. A wide gap separates those who hold that the fetus is a person meriting respect and some rights on the one hand, from, on the other hand, those who consider the fetus to be a set of tissues or cells without moral value per se, and deserving of no special treatment. Intermediate positions propose other factors like viability and the capacity for feeling, but they do not achieve a consensus. The above distinction between internal and external reasons explains why the two positions continue to confront each other and why no progress has been made in the discussion. Even though each position offers grounds for its defense, these grounds belong to different motivational sets. For the pro-lifers, the pro-choice lines of reasoning are completely external and vice versa. Each follows the same reasoning that Owen’s family gave. Owen’s family had strong reasons, reasons that belonged to the family’s own motivational set. Yet, these reasons were entirely external for Owen as he did not share their beliefs. The same is true of the line of reasoning used to defend or attack abortion. A mechanism of internal beliefs exists that is external for some and does not hold for the others. The proffered analysis and reasons are external. Besides not helping to solve the discussion or to influence the participants in modifying their positions, external reasons merely lead to a dead end.

4. Internal Reasons and Abortion Based on the distinction between internal and external reasons, consider what would happen when only internal reasons prompt action. If Williams is right, a change in an agent’s motivation to act will only occur when the line of reasoning is based on internal reasons. Only through consensus on internal reasons can we attempt to find a solution. External reasons are sterile and cannot lead to action or to a change in beliefs. Internal reasons must be understood in this case as beliefs shared by the pro-choice and the pro-life alike. In this way, the internal reasons are not merely each group’s reasons for action, but the internal reasons that inspire both groups to act. The objective is to use internal reasons to show how previously accepted premises do not hold and how we can begin to propose a new perspective in the discussion. The possibility of appealing to beliefs shared by both persons (prolife and pro-choice) is crucial. If it is possible to convince a person that belief A (one of the beliefs in conflict) contradicts belief B (a belief upheld by both agents), then a solution to the conflict becomes feasible. The agent must disre-

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gard belief A and adopt another, C or A', which is coherent with belief B and with the rest of the agent’s beliefs. Consider a biased position against pro-choice: Argentina’s anti-abortion legislation. This legal instrument reflects the pro-life stance. However, a detailed analysis reveals inconsistencies, and will ultimately lead to a rejection of the basic premise of the pro-life position. Obviously, no law is universal although this law reflects beliefs shared by a large part of the community. Argentina’s anti-abortion legislation reflects the maximum of tolerance the prolife perspective can accept and the minimum requirement a pro-choice position may accept. this point will become clearer when we consider the exceptions to the law. The first premise held by the pro-life camp, and which underlies the Argentine anti-abortion legislation, is that abortion is outlawed because the fetus is a person from conception. However, Article 86 of the Penal Code says: An abortion practiced by a licensed physician, with the pregnant woman’s consent is not punishable if it is done to prevent a danger to the mother’s life or health, and if said danger cannot be avoided via other methods; and, if the pregnancy is the result of a rape or an attack on the virtue of an insane or mentally deficient woman. These exceptions are accepted by virtually all those who uphold this prolife position. They reflect commonsense and the comprehension of thorny situations. The exceptions serve as a minimum basis for dialogue. We cannot rule out extreme or fanatical positions, but a dialogue or a rational discourse with fanatics is unfeasible. However, many pro-life supporters (be it for moral or religious convictions) are open to exceptions when they imply a just and humane position. The motivational set of the pro-life camp could be understood as an attempt to provide an ethically just proposal. It circumvents the rigorous and extreme position that re-victimizes rape victims or women whose lives are jeopardized. Within this spirit we can defend some humane exceptions that are acceptable to all. At the same time, these are the exceptions that a pro-choice person would accept as the minimum. A common core exists that both positions would be able to acknowledge. This core of beliefs makes up the set of beliefs both positions hold, and influences their motivational sets. Instead of focusing on the basic premise that abortion is outlawed because the fetus is a person from conception, which we have seen is questionable, let us examine what a minimum level of agreement entails, and how it can be used from the internal reasons perspective. Consider the first point of agreement: that which allows abortion when the mother’s life and health is at risk. Such a case would appear to be easy to explain because of the conflict between the life and the death of two “persons” (the mother and the fetus). Yet, why does legislation prioritize the mother, or

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still her health, when the other party is an “innocent person?” (The Catholic Church, for instance, generally defends the fetus as an “innocent person”). It is quite difficult to defend this exception without falling back on the idea of actual persons and potential persons. However, incorporating these distinctions can lead to the establishment of different rights for actual persons and potential persons, and the fetus as such loses its privileged position. In order to be able to permit this first exception, the Church appeals to the principle of double effect, which is debatable, in that it depends crucially, of course, on a person’s conception of intentional acts. 9 Even more difficult is justifying abortion when the mother is retarded or insane. Though she may be mentally challenged or insane, her child is still a person from the moment of conception. The mother’s life is not at risk, nor is it certain that the fetus will be handicapped. The baby may well be charming and healthy. Why should it be destroyed? According to the basic pro-life premise, factors exist that can justify this exception. We can cite difficulties in childrearing and education, but these reasons are too broad and ambiguous, and they can also be applied to single teenagers, and families that are poor or that have numerous children. And these latter reasons are by no means acceptable to the pro-life camp. The third case, in which the prospective parent is the victim of rape, is the “worst” of all. It is not a conflict of rights between two lives (the first exception); there are no problems concerning childrearing or a “defective” mother (the second exception). What grounds justify killing an “innocent person” here? We can find strong problems with the third exception. In the original Spanish, the language is ambiguous or unclear. Some interpretations of this law judged that the mother had to be insane or mentally challenged, as well as raped. This conservative interpretation of the law took the clauses “if the pregnancy is the result of a rape” and “an attack on the virtue of an insane or mentally deficient woman” as meaning only one exception. The three-exception position, instead of considering the “or” as an inclusive disjunction, read it as an exclusive disjunction. The three-exception position, which derives from an old swiss penal code, implies that an abortion is not forbidden (1) when the woman´s life or health is in danger; (2) when the pregnancy is the product of a rape; (3) when the pregnancy is the product of an attack on an insane or mentally deficient woman. The conservative interpretation only allows two exceptions: (1) when the woman´s life or health is in danger; and (2) when the pregnancy is the product of a rape and an attack on an insane or mentally deficient woman. Nevertheless, minimally compassionate people would consider that a rape victim is entitled to an abortion. It is too much to ask that a woman who has experienced such a tragedy, should be condemned to give birth to an unwanted child. Take the explicit cases of teenage rape victims. The State does not penalize abortions in these circumstances. However, in 1998, several cases arose of mentally challenged young girls who had been raped and had been

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denied assistance (even if they met the more conservative interpretation of the cited law). Maintaining the three exceptions poses serious problems to the person who also upholds the basic premise. That is, most people (pro-abortion and pro-life) share a belief in the viability of the exceptions, whilst only the pro-life camp maintain the basic premise. That being the case, let us leave aside the basic pro-life premise and maintain the core of beliefs that would function as internal reasons. Given the inconsistencies in the exceptions, pro-life supporters could argue for the basic premise and disregard the exceptions. This, however, would take the discussion back to a situation of total intolerance, where special and unforeseen circumstances are unthinkable—the abortion issue would be taken a step backward. It would become the banner of fanatics and not of rational beings who seek the best possible solution to adverse conditions while maintaining their ideals. Note that pro-lifers should not be the only ones to yield. For the prochoice camp, the core of beliefs is the least they can accept. and in no way corresponds to the proposal for abortion on demand that they defend. Concurrence concerns basic beliefs. With these beliefs as a common basis, the two camps will have to decide what is and is not acceptable. They will both have to make concessions if they want to achieve a common agreement. An interesting proposal along this line is a strategy based on paradigmatic cases, taking exceptions as paradigms and working to find other cases that respond to the criteria that are implicit in these exceptions. Yet, this is only one alternative. What follows from there remains open for the time being.

5. Conclusion This chapter has examined the debate on the moral justification of abortion, trying to see whether Williams’s distinction could help place the discussion on another level. It considered how the traditional approach to the discussion uses external reasons (reasons that are completely foreign to the opponents). Instead, if Williams was correct about the motivational aspect of internal reasons, appeal to such a notion could help modify the situation. Taking the shared core of beliefs as internal reasons, the chapter examined the inconsistency implied in maintaining such beliefs and the basic pro-life premise. Abandoning that premise and sustaining the shared core of beliefs places the discussion in a new light. This chapter does not attempt to solve the abortion debate. It tries to establish a better point of departure for the discussion by analyzing other viable cases, what their exceptions are, and why. An incipient concurrence is possible, as well as ways to leave aside beliefs that contradict the common base. Instead of arguing from opposing positions that lead nowhere and do not resolve the controversy, this proposal could help build a consensus based on shared beliefs. It involves making a serious attempt at dialogue. It disregards extreme and

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intolerant positions. It is an exercise that is still pending in many Latin American societies.

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Five TO PROCREATE OR NOT TO PROCREATE? AIDS AND REPRODUCTIVE RIGHTS 1. Introduction The previous chapters analyzed one manifestation of the lack of respect for persons—unjustified paternalism toward patients—and called attention to the need for further dialogue. This chapter examines another topic that is frequently associated with intolerance: reproductive rights. It considers the rights of pregnant women with Human Immunodeficiency Virus (HIV), and ethical and theoretical problems related to reproduction. The issue is complex, as are the different variables in the decision-making process. They reveal how inappropriate an a priori paternalistic attitude is. This chapter argues for the prioritization of a mother’s or parents’ responsible and informed decision. Consider the case of Acquired Immune Deficiency Syndrome (AIDS), a condition which presents troubling situations and reflects some of the dilemmas that AIDS patients face before and during pregnancy. That is, women with AIDS must decide whether to have a child and risk perinatal transmission. The chance of transmission without Zidovudine (AZT) treatment during the pregnancy ranges between 18 and 25 percent, and between 5 and 8 percent with treatment (according to protocol 076 or prolonged treatment). Recent reports in the United States say that chances of infecting the child are even lower. 1 The discussion of these cases reveals some assumptions concerning reproductive freedom in Argentina and other Latin American countries. It shows how an indiscriminate endorsement of procreation as a positive value generates paradoxical feelings toward HIV-positive pregnant women, as well as how influential some traditions and religions are.

2. Reproductive Rights Let us examine the notion of reproductive rights: the freedom to procreate without the interference of others (as was established in the United Nations Declaration of Human Rights in 1948) and the freedom not to procreate (via abstinence, contraception, or abortion). That the moral justification of abortion has its advocates and fierce critics is well known. 2 Analyses of complex ethical dilemmas to define the moral status of the fetus, and of conflicts in women’s rights, go beyond the scope of this book. However, if arguments can morally justify abortion, then, given reproductive rights, abortion could be considered an alternative for infected pregnant women. This is especially relevant in the

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case of pregnant women who have to decide whether to continue their pregnancy, since fetal malformations can result from the illness or the drug therapy. This situation can end in an abortion and may imply possible maternal-fetal conflicts. Two issues stand out regarding the right to reproductive freedom: its moral justification and the conditions that make it possible. Despite greater or lesser degrees of social acceptance and legal regulations, a general consensus morally justifies reproductive freedom. 3 Yet, neither Argentina nor many other Latin American countries have enacted federal policies to protect it. One of the strongest moral justifications of reproductive freedom invokes the principle of autonomy. Reproduction, a highly personal decision, is intimately tied to an individual’s lifetime plans and to the psychological, social, and physical impact of having a child. The principle of autonomy implies a moral obligation to treat others as responsible human beings. It means respecting the future plans of persons who base their autonomous decisions on full information and their values. Dan Brock has written extensively on the concept of self-determination from which the notion of reproductive freedom is derived. 4 A utilitarian approach can also justify reproductive freedom. This philosophical position considers the overall sense of well-being in being able to choose if and when to have children. However, the utilitarian perspective suggests that overpopulation or poverty might legitimately limit reproductive freedom. A point worthy of mention is that, from a feminist perspective, reproductive freedom places men and women on an equal footing, in so far as it considers how reproductive decisions will affect women’s lives. In Latin America, another relevant factor is justice. Poor women are a vulnerable population. They lack education and resources, and this places them at a disadvantage in comparison to women with more resources. Frequent or unwanted early pregnancies seriously threaten their chances of work and education. Their poverty may increase, and they may experience a worsening in their health and nutrition. A situation like this reveals how the lack of respect for reproductive freedom fosters inequality. The disadvantageous condition that these women face deprives them of future opportunities. Having accepted that reproductive freedom is morally justified, we need now to consider the conditions that make it possible. Herein lie the greatest problems in Latin America in general, and in particular in Argentina. In 2000, the city of Buenos Aires, one of the largest and most developed cities in the region, enacted a law for responsible reproduction. The most conservative religious groups countered with intense opposition that blocked all chances of a federal law for a further couple of years. They resorted to legal appeals, and compared the law providing information and contraceptive devices to an antifamily, pro-abortion campaign. Only in 2003 was a national law passed concerning sexual and reproductive rights. This law created a national program for the provision of contraceptives in public hospitals, sex education, and the

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diagnosis and treatment of sexually transmitted diseases as well as ovarian and breast cancer. However, the proposed program generated strong criticism from the Catholic Church. A non-governmental pro-life organization brought a suit and obtained a judicial decision (later on reversed) forbidding all use and sale of contraceptives. The prohibition was so strong and blunt that contraceptives were not allowed even in the cases of medical use for gynecological or fertility problems. The cases above exemplify the great difficulties and continuous obstacles for reproductive freedom in this region. In sum, the fundamental prerequisite for genuine respect for reproductive freedom is tolerance. Respect implies accepting that fertility can be regulated in multiple ways and that religious convictions need not guide the decisionmaking process. Respect for persons and tolerance are difficult to instill in a country marked by intolerance, exaggerated paternalism, and authoritarianism. We have seen how “intolerance” has been conceptualized as a “virtue.” Lack of respect also condemns the most vulnerable: poor women. This is not a middleand upper-class problem, where women can access contraceptive methods privately. The problem targets the poor who are deprived of contraceptives and appropriate information. Access to contraception is still a major problem in Argentina, and in most Latin American countries. Reproductive rights may be obvious and taken for granted in many other countries. However, in most of Latin America they are still a pending issue, and no clear solution is evident.

3. What are the Limits on Reproduction? Despite the above justifications for reproductive freedom, the AIDS issue may serve as a constraint. Without disavowing the prima facie character of people’s moral right to procreate, it is questionable whether they have the right to bring children into the world when doing so involves knowingly causing them great harm. This poses a series of considerations and limits on reproductive freedom. For example, what are the moral obligations toward children? What are the criteria for restricting reproductive freedom? Note that Argentina, in particular, takes a non-critical attitude toward procreation owing to the lack of reproductive freedom. Having children is positive. Despite the basic “pro-natal” position, we could argue about the injustice of giving birth to a child. This chapter reviews some of the “classic” literature and analyzes different positions and theoretical problems in relation to AIDS and reproduction. A. To Be or Not To Be. Is That the Question? A first consideration questions whether existence itself is necessarily a good. The English philosopher, Derek Parfit, carefully examines whether we can

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commit an injustice by bringing a child into the world. He gives two imaginary examples involving two women: The first is one month pregnant and is told by her doctor that, unless she takes a simple treatment, the child she is carrying will develop a certain handicap. We suppose again that life with this handicap would probably be worth living, but less so than a normal life. It would obviously be wrong for the mother not to take the treatment, for this will handicap her child . . . . We next suppose that there is a second woman, who is about to stop taking contraceptive pills so that she can have another child. She is told she has a temporary condition such that any child she conceives now will have just the same handicap; but that if she waits three months she will then conceive a normal child. It seems clear that it would be wrong for this second woman, by not waiting, to deliberately have a handicapped rather than a normal child. And it seems (at least to me) clear that this would be just as wrong as it would be for the first woman to deliberately handicap her child. 5 Parfit’s two examples suggest that we can harm persons by giving them existence under adverse conditions. In the first case it is wrong not to take the treatment; in the second, not waiting is equally wrong. According to Parfit, these actions are morally equivalent. Nevertheless, the two women’s actions are different. The first woman’s actions are carried out in the best interests of her child. What she does will prevent the child from being born with a disability. But, this is not true in the second case, since no child exists to benefit from her action. If she postpones conception and takes the treatment, she harms the interests of her childthe one she supposedly was to conceivesince she is causing the child not to exist. We can object that the unconceived child does not exist at any rate and, more importantly, will never exist. Therefore, the child cannot be harmed. 6 Parfit wants to explain why making people start to exist benefits them, while not doing so does not harm them. This position has given rise to elaborate distinctions and discussions. The philosopher and bioethicist John Harris examines the problem and finds Parfit’s analysis puzzling. He notes the difficulties of applying Parfit’s account to the morality or immorality of some interventions in gametes or in embryos because of genetic problems. Likewise, he maintains that Parfit has not dealt with the specific issue of his concern, specifically, the treatment of what he calls “pre-persons.” In this vein, he says that Parfit appears to urge us to date a person’s start of life as the first moment in which he or she can benefit from things done or not done to him or her. Parfit does not appear to question Thomas Nagel’s suggestion that this point is at birth or immediately before birth. He also appears to accept that an individ-

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ual’s life starts just when the unique genetic make-up of the emerging individual is first present, that is, when the zygote is first formed. Moreover, Harris points out that Parfit persuasively suggests that the moral obligation to do things or to refrain from doing things to individuals must be justified in personaffecting terms. That is, their morality turns in large part on the effect they have on people. Persons are affected by what happened to them as pre-persons. However, doing things to pre-persons that prevent them from ever becoming persons cannot be handled by a person-affecting morality, unless they have side effects that impact on persons. 7 If we accept the existence of a pre-person in Parfit’s second imaginary case, the pre-person would not be affected by not becoming a person. Applying these distinctions to the sick or infected woman who must decide whether to conceive clearly shows the different moral standards for persons and for prepersons. Harris’s arguments help reject conception under some circumstances, but they do not offer an explicit guideline for the case of AIDS. One issue is the possibility of benefit. This is not a case of postponing pregnancy. The risk of transmission would continue to exist. We need a subtle approach to help distinguish the impact of different disabilities when evaluating whether a life with such disabilities is worth conceiving. This small sample illustrates the theoretical complexity behind these comparisons: the difference between “not existing,” “starting to exist,” “starting to be a person,” and the harm or benefit to persons. We will see how a particular asymmetric relationship can arise regarding harms to persons and to pre-persons. These are metaphysical or ontological difficulties. At the same time, this approach also leads to the controversy of defining the person a problem over which no consensus exists. Arguments vary from positions that the zygote is a person 8 to those demanding higher standards like selfconsciousness. 9 In addition, we need to clarify the concept of the “pre-person” that Harris incorporates. Although the resolution of these complex problems goes beyond this book this chapter presents the theoretical complexities involved and shows how some of the most relevant contributions can be applied to HIV reproductive problems. B. And the Child’s Interests? Since Parfit’s proposal does not suffice, another possible resolution considers the child’s perspective: the possible child’s interests or quality of life. Bonnie Steinbock and Ron McClamrock analyze Joel Feinberg’s position on this question. Feinberg states that someone can have an interest in not being born if his or her existence is inexorably and irreparably such that life is not worth living. Feinberg says:

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BIOETHICS AND VULNERABILITY: A LATIN AMERICAN VIEW Talk of a “right not to be born” is a compendious way of referring to the plausible moral requirement that no child be brought into the world unless certain very minimal conditions of well-being are assured. 10

Such minimal conditions are equivalent to the demand that we not condemn the future interests of the child to total failure. Feinberg proposes an examination of harm as the thwarting, setting back, or defeating of an interest. To have an interest in something is to have a “stake” in it. In general, a person has a stake in X when he or she stands to gain or lose depending on the nature or condition of X. “One’s interests, then, taken as a miscellaneous collection, consist of all those things in which one has a stake.” 11 Steinbock and McClamrock explore whether someone is “worse off” for coming into existence or “better off unborn.” They say a requirement for judging whether someone is better off dead is that that very person considers life not worth living. But this is not applicable to the cases here: children cannot express their preferences; they do not yet have the necessary intellectual equipment to have the relevant preferences. Infants cannot understand the choice between severely handicapped existence and no existence at all. They cannot weigh up benefits and harms to reach a decision as to whether life is, on balance, worth living. Therefore, it does not make any sense to ask what infants would want. The test of “substituted judgment” is simply inapplicable in the case of never-competent individuals. 12 Feinberg proposes, then, a “proxy chooser” who acts as the infant’s advocate, concerned to promote his or her general welfare. The proxy chooser: [. . .] exercises his judgment that whatever interests the impaired party might have, or come to have, they would already be doomed to defeat by his incurable condition . . . . 13 Steinbock and McClamrock note that this response, though correct, would be applicable in very few cases. The “doomed to defeat” test Feinberg proposes only appears to apply to appalling cases in which the child faces chronic pain, together with such severe mental retardation that developing any compensating interests is impossible. The section “Principle of Parental Responsibility” incorporates another criterion that goes beyond Feinberg’s limitations. Even though Feinberg proposes a conscientious examination of the topic, one of his main concerns is the legal consequence implied in this kind of birth. He does not analyze the moral evaluation of whether the action is right or wrong. Rather, he considers when a “wrongful life” justifies a legal action, that is, a legal action “initiated” by the infant or the proxy against the physicians or the child’s parents. Thus Feinberg makes careful distinctions between “harming” characterized as placing in a worse off situation, or “unfair” treatment and “wrong doing.” For Feinberg, no harm has been done to the victim of a wrongful life; and a wrong has not been

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committed unless the consequences for the child are so severe that his or her life is not worth living. Feinberg tries to remove “wrongful life” from the domain of penal law and place it in the moral realm. He consequently sets extreme conditions to identify when a wrong is being committed (that is, when life is not worth living). So, there is a gap between the notion of “harm” and of “wrong doing.” In addition, if “harm” means worsening a condition, we inevitably have to compare existence under condition X with non-existence. This kind of analysis makes it difficult to answer the question on the limitations of reproductive freedom. In light of the issue of the possible pregnancy of an AIDS sufferer, this extreme and demanding criterion appears to endorse reproduction, since the future interests of the child have not been totally damaged. Should children be brought into the world although they might suffer a disease like AIDS and, since their parents have the same disease, possibly become orphans? Instead, it might be preferable to examine avoidable suffering and parental obligations and responsibilities when deciding to have a child. C. The Wrong of Needless Suffering Another approach explores needless suffering, and studies the possibility of avoiding it. Harris presents his own position that it would not be wrong to give birth to needless suffering: The fourth woman is pregnant and is told that the child she is carrying will be born with a disability; moreover, that unfortunately any future children she has will also be born with the same disability. If she is to have children at all they will have disabilities and no pre-natal or postnatal treatments are available to ameliorate the disability. 14 For Harris, the suffering of a disabled child is unavoidable because the mother cannot have a child without disabilities. He explains that so long as the disability is not so great or so terrible that it would be better for this potential person—or, indeed, anyone with such a disability—that she had never been born, then it is in the interests of the child to be born. He recognizes that the case is complex, since the child will be born with a disadvantage. However, Harris maintains that this is a case in which disabling a person does not constitute a wrong to that person. 15 According to Harris, it is wrong to bring avoidable suffering into the world. It is better to have healthy children than disabled ones. But, unless the disability or suffering makes life intolerable, it is better to have disabled children than not to have them. He clarifies that even though it is wrong to bring avoidable suffering or disadvantages into the world, the child has not been wronged unless the disability is so severe that life is intolerable. The wrong is that of an individual deliberately choosing to increase suffering in the world when she could have avoided doing so.

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Harris’s analysis is more fitting to the case of AIDS. According to this line of reasoning, even though the child is harmed, the infected or sick woman does not wrong the future child. So long as the handicap is unavoidable, the child is better off born than unborn. Contemporary science tells us that the child of an infected or sick woman is at risk. In this sense, suffering or disability is unavoidable and, according to Harris, it would not constitute a wrong to bring the child into the world. At the same time, the requirement that a disability be so great or so terrible that no one would wish to be born does not hold. Besides taking combined drug treatment, there is between a 75 and 95 percent chance of the child of an AIDS sufferer being born healthy. Harris’s proposal also shows that the woman must follow protocol 076 or some kind of AZT therapy to reduce mother-to-child transmission. When Harris speaks of attitudes toward possible genetic improvements in future children, for example, providing genetic immunity or delaying the aging process, he argues that it is the parents’ obligation to provide genetic protection. 16 However, Harris’s analysis might be problematic since it focuses mainly on the parents. It prioritizes the “parents’ desire to procreate.” If they cannot avoid having disabled children, then they can have disabled children. Reproductive freedom is not questioned except in severe cases. Another way of endorsing this perspective is by indicating the consequence of “requiring” the procreation of only “perfect babies” and the implicit discrimination in a position against having disabled babies. However, the stance against HIV-positive women having children does not necessarily follow the reproductive canons that demand perfect babies. Regarding the “unavoidability of suffering,” the North American philosopher Frances Myrna Kamm takes a different critical line in her analysis of the case of “no worse claim.” 17 She compares different possible states of the world (SW), first considering SW1, in which there are people but no one is in pain, and then SW2 in which one person is in pain. After examining different cases she concludes that when more people suffer pain or death without an improvement in any person’s condition, the world is worse off. This judgment is made from outside the point of view of each person, but bears in mind each individual’s point of view. This is also the kind of analysis Allen Buchanan, Dan W. Brock, Norman Daniels, and Dan Wikler make regarding the situation. They appeal to a “neutral” principle (Principle N). 18 Harris may try to defend his position by appealing to the difficulties in the interpersonal comparison. It is not so easy to compare different persons and their situations when the suffering or loss differs so greatly. This is the case with AIDS and, perhaps, the feeling of “salvation” or “sense of life” that having a child means to HIV women facing possible perinatal transmission. In fact, the possibility of HIV-positive women choosing to have children has been defended. The argument points out how significant motherhood is to some minorities, and how pregnancy or a child genuinely sustains these women

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in their struggle against the disease. Taking away this opportunity further reduces the few meaningful alternatives in their lives. So, the comparison between SW1 and SW2 may consist of a world (SW1) where a baby with AIDS is born, and another (SW2) where that baby is not born but the mother suffers severely and lacks a sense of life. Even though Harris may try to defend his position with this kind of argument, it is still rather controversial. D. The Principle of Parental Responsibility Does a more specific and more conclusive criterion exist for difficult cases? In “Can Having Children Be Immoral?” 19 Laura Purdy formulates this question in cases of genetic risk. She defends the moral obligation to provide at least the opportunity to have what be regarded as “normal” health in the culture in which the future child will live. Purdy is aware of the problems in establishing a “minimally satisfying life” or what “normal for that culture” is. She clarifies in a footnote that some human groups are so badly off that it might still be wrong for them to procreate, even if that would mean great changes in their cultures. 20 Purdy argues against having children that may develop Huntington’s disease. A person with this genetic disorder begins to suffer at about the age of forty without having experienced any prior symptom or physical manifestation. Nonetheless, she argues that since possible children do not presently exist as actual individuals, they do not have the right to be brought into existence, and, hence, no one is wrongfully treated by measures to avoid the conception of a possible person. 21 Purdy’s criterion, based on socially acceptable standards, offers little satisfaction for our inquiry. When it comes to anomalous genetic diseases, it may be a relatively useful criterion. However, it is difficult to evaluate whether being born with AIDS is “normal for a culture.” This disease is becoming increasingly more widespread and is considered a pandemic, as well as a “chronic disease.” Along a similar line, Steinbock and McClamrock shift the limit on reproduction away from the parents interests to the children interests. They propose a principle of parental responsibility that advises potential parents to abstain from having children unless they can satisfy decent minimum conditions. People should not be concerned only with their own interests in reproducing. They must also, and perhaps primarily, think of the welfare of the children they will bear. They should ask themselves, “What kind of life is my child likely to have?” If they cannot offer them even a decent chance at a good life, it is better not to have them since it is unfair to children to bring them into the world with the deck stacked against them. 22 Steinbock and McClamrock ask whether it is justifiable to create a child who is likely to be marked by pain and severe limitations, and answer that it is not. Indeed, they ask what reasoning could justify an affirmative answer. Is it

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that the child’s life, while miserable, is not so awful that he or she will long for death? That is not the kind of answer a loving parent could give. Anyone willing to subject a child to a miserable life when this could be avoided does not appear to live up to a minimal ideal of acceptable parenting. Thus, they affirm that a child’s being destined to a miserable life may well count strongly against bringing the child into existence. However, that the child would have a happy life if brought into existence does not obligate the prospective parents to have the child. 23 If one decides not to have a child, one harms no one. No one is injured or made unhappy or deprived by nonbirth. 24 However, Steinbock and McClamrock do not suggest that people must not have children unless the conditions are ideal, much less that only conventional circumstances for childrearing are morally permissible. In fleshing out this claim, they review different situations and say that under some circumstances, all that is required is to put off maternity, as in Parfit’s classic example of the fourteen-year-old teenager who wants a baby. The principle of responsibility indicates waiting, since doing so will ensure that the teenager will be a better mother to the child she will eventually have. Under circumstances where the risk consists of transmitting a disease, be it a genetic condition, such as sickle-cell anemia or cystic fibrosis, or a viral infection like AIDS, the possible parents will have to base their decision on factors like risk of transmission, the nature and severity of the disease, the availability of therapies, the possibility of a cure, and the ability to provide the child with a decent life despite its disadvantages. In the case of AIDS, Steinbock and McClamrock maintain an unfavorable position based on available scientific data. It should be borne in mind that the article was published in 1994, and dramatic changes in AIDS therapy have since occurred. 25 Note, though, that Steinbock and McClamrock extend the notion of parental responsibility to lives that begin beyond the extreme condition Feinberg suggests. The principle of parental responsibility does not offer an exact formula. Reasonable people can differ on what a decent chance at a happy life is and what risks are worth taking. 26 The major problem is how far-reaching this principle is. An excessively demanding position can produce discriminatory criteria which entail that some social groups, for example the poor, should not reproduce. An overly permissive position, however, can end up justifying the preferences of parents over the suffering of their children. In a Mexican publication, Brock presents Onora O’Neill’s view that the right to reproduce depends on whether the future mother or father “has or makes a feasible plan for the child to be reared correctly by them, or others who are willing to do so.” 27 Brock defends this position so long as it prevents potential harm to the fetus and the child the fetus becomes. He says that reproduction without a feasible childrearing plan is irresponsible. It affects other persons who will have to participate and assume the responsibilities involved in childrearing. This criterion considers the interests of the possible child and of the other members of society. Brock recognizes the difficulty in defining the

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notion of a “feasible and correct childrearing plan.” He says this idea would deny mentally challenged persons reproductive freedom, and could apply to the least socially and economically favored. An obvious moral concern about this limitation is that its effects would fall disproportionately on those least favored, as well as on less developed countries. Brock does not consider that this limitation is wrong, but that it offers one more moral reason to remedy social and economic disadvantages. However, this kind of proposal imposes another burden on these populations that could prove discriminatory. Given the substantiated accounts of abuses like the forced sterilization of women in developing countries, we should be careful about accepting this proposal.

4. Who Makes The Moral Decision and How? What happens to these proposals in the decision-making process? A review of the most relevant elements presented above shows similar tendencies. Parfit’s and Harris’s consequentialist perspective introduces a limit in extreme cases. Feinberg’s position, with stronger deontological commitments, agrees. Harris also recognizes the weight of parental obligations. Consider his position on parental responsibilities and possible genetic improvements for the children. Even Purdy, writing from a feminist standpoint, advocates parental obligations and responsibilities. Steinbock and McClamrock also endorse the principle of parental responsibility. However, some gaps and ambiguities persist. For example, Harris’s proposal is quite broadthe avoidance of needless suffering. What happens in non-extreme harmful situations? Though Steinbock and McClamrock’s responsibility principle offers more specific guidelines, we should go further in examining moral deliberation. This is the responsibility of the woman or the couple. And this is a fundamental point. An implicit element in the above views is the complex notion of harm. In the nineteenth century John Stuart Mill had already formulated the principle of no harm. The freedom of competent adults was unlimited, except where that freedom may cause harm to others. But, no consensus determines when harm is severe enough to warrant limits on reproductive freedom. The key is establishing the severity of the harm, its irreversibility, and its probability. What are the possible benefits to those involved, for example, the woman, the fetus, the parent, and society? All these factors must be contemplated in the moral evaluation of the situation. So, we should consider a five percent mother-to-child transmission with a prolonged AZT treatment from the fourth month, a programmed cesarean section and no breast-feeding, or a twenty-five percent chance of infection without any treatment. Recent studies show that lower doses of AZT also protect the fetus and are less expensive. 28

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As to the child’s quality of life, we should evaluate the ten to twenty percent chance that the possible child will fall ill and live no more than a year in the most serious of cases. Instead, children who fall ill after the first year will have a better quality of life and will live longer. As the next section describes, socio-economic possibilities of obtaining treatment are highly relevant. Fundamentally, can the state provide the drugs for therapy? Will the parents have access to proper treatments for their children, which in the case of AIDS are especially expensive? Note potential scientific advancements that will improve the future child’s perspectives. In the case of AIDS, it is more difficult to calculate the severity of the illness. In only a few years it has progressed from being an absolutely deadly disease to a possibly chronic one. The latest combined drug therapies offer highly promising prognoses for the patient’s quality of life. However, many doubts persist about long-term harms or problems these treatments may produce. Insufficient data, tests, and research give rise to uncertainty over the probable evolution of the illness. It is essential to consider the limitations on reproductive freedom that AIDS cases call for, but these limits are far from clear. With extremely dissimilar data and uncertainty about the risks, harms, and benefits, they imply highly subjective values, for example, about responsibility. Given these factors, perhaps only the mother or the parents should decide whether to have a child under the circumstances. Even though Steinbock and McClamrock’s principle of parental responsibility is relevant, it is fundamental to consider the parents’ beliefs and decision-making power.

5. Decisions in the South What do these conclusions imply in practice? How relevant is the proposal to countries like Argentina and the rest of Latin America? The principle of parental responsibility reflects common sense. However, it involves a deep change in these societies where the weight of decision-making traditionally falls on the physician, and where an incipient respect for persons has only recently begun to appear. Consider the case within the framework of a strongly paternalistic society. Though the couple makes decisions on reproduction intimately, the illness involves categorical medical indications. Thus, the physician unilaterally “determines” the reproductive decisions. Accepting the principle of parental responsibility, instead, implies that it is the woman’s or the couple’s decision. Parental responsibility gives the mother or the couple the status of moral agents who can balance something so basic as the rights and wrongs of bringing a child into the world. Just as the importance of a patient’s informed decisions or informed consent is fundamental to the physician-patient relationship, so is the importance of the woman’s or the couple’s informed and responsible decision.

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Though these cases involve the existence or nonexistence of a third person, stressing responsibility also stresses moral obligations toward others, such as providing suitable medical attention to prevent the transmission of diseases. In this sense, infected women or AIDS patients deserve correct and up-todate information about their situation and that of their future child. Women and couples must be informed about the risks to future children, and about their likely quality of life and life span. They must also be informed about the potential consequences for the future mother’s health, the probable evolution of the disease, and the chances that the child will become orphaned. They must consider the issues of who will have to rear the child and how the costs of doing so will be covered. This approach endorses an uncontroversial practice: informed consent. The well-informed mother or couple can responsibly decide about having a baby and trust scientific progress and precautions to avoid mother-to-child transmission. One possible objection to this position stresses the AIDS patient’s past lack of control, and denies her another chance: that is, she has become infected because of a supposed lack of control. Advocates of this position consider the difficulties many women find in practicing safe sex with their partners. This objection is based on an especially biased and derogatory stance, which denies persons the chance to alter their situation. Finally, consider the paradoxical situation that Argentine women, and especially HIV-positive women, confront regarding reproductive freedom. They face a highly conservative society and, in practice, a widespread double standard. Few Latin American countries have national laws on responsible reproduction that instruct women about family planning. Even though some isolated family-planning or responsible-reproduction programs exist, they are not coordinated. This generates immense social injustice, as middle- and upper-class women have access to contraceptive methods while poor women—who make up more than half of the female population—do not. Especially alarming is the situation in northern Argentina, with its high percentage of adolescent and teenage pregnancies, not to mention a high maternal-mortality rate from unwanted pregnancies. 29 These deficiencies are startling and extremely relevant in light of the AIDS situation today. Some powerful political social sectors object to reproductive rights. Argentina has witnessed strong opposition to responsible reproduction laws at the national and provincial levels. The defense of responsible reproduction has been compared to genocide. Religious and anti-abortion groups that hold life to be sacred and consider the fetus a person, encourage indiscriminate procreation, even though they accept natural family planning methods. 30 Moreover, Argentina has no national law that permits abortion owing to serious illnesses, malformations, or even anencephalic fetuses. When an infected woman becomes pregnant, society stigmatizes her. This poses a paradox wherein sick or infected women are not to have children. Yet, this same society does not educate women on reproductive health. It does not

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teach women how to avoid unwanted pregnancies, nor does it teach them how to protect themselves from AIDS. This society continues to promote an authoritarian and paternalistic attitude where women are reduced to the status of children and are not treated as responsible moral agents. Intolerance and the lack of respect toward persons still govern.

Six ASSISTED REPRODUCTION AND LOCAL EXPERIENCES: WOMEN AND CONTEXT IN LATIN AMERICA 1. Introduction Chapter One distinguished between “provocative” and “boring” problems in bioethics. Reducing specific problems to specific countries can be controversial, but the “division of labour approach” is still prevalent in many bioethical settings. According to this view industrialized countries should focus on “scientific advancements” like the use of stem cells or embryos in research. Developing countries should examine the distribution of resources or the lack of respect for some basic rights. Each of these problems corresponds to different “realities” of these countries. Yet, even if we recognize that problems can be cataloged regionally, and even if we concede that countries that develop technologies should be the ones to analyze their new ethical implications, we cannot ignore the ethical view that developing countries make of these developments. This chapter examines the case of assisted reproduction. It considers how technological developments, which are being quickly adopted worldwide, impact on developing countries. For example, intracytoplasmatic sperm injection (ICSI) was implemented in Latin America within only three years of its adoption in industrialized countries. It is simply incorrect to think that Latin American countries have no experience of techno-scientific ethical problems. The response to Assisted Reproduction Technologies (ART) in the United States or Europe differs from responses in other societies. Consequently, “provocative” and “boring” problems must be examined within the context in which they are applied. This chapter analyzes the subtle influence of social context when implementing new techniques in assisted reproduction. It tries to show that what is most questionable about this kind of proposal is not the distinction between problems (categorizing them as boring or provocative), but the identification of each set of problems with the development or lack of development of countries. The chapter will take the moral justification of ART as given. It will focus on the simplest techniques, such as artificial insemination with or without donor, and the most complex methods, such as in vitro fertilization or ICSI. A clarification and a caveat are necessary. In no way can Latin America be called a homogenous region. As the Introduction explains, it embraces a variety of countries. Each culture influences conceptions of fertility and infertility. So, the

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generalizations that are formulated in this chapter must be considered within this framework. At the same time, Latin American countries share some relevant characteristics, such as the wide gap between the poor and the middle- and upperclass sectors of the population and the strong presence of Catholicism. Although the profile of the Church varies across the region, the Catholic religion has always had a powerful influence on reproductive issues. The issue of ART is no exception.

2. Disclosure and Embryos for Transfer Before discussing problems of greater local impact, we should examine two debatable issues that arise when implementing these techniques. One is the question of disclosure in techniques using donor genetic material, for example, in the use of gametes, oocytes, or embryos. A tradition exists based on secrecy and silence. The Chilean physician, Fernando Zegers-Hoschchild says: In countries like Chile, fewer than ten percent of the couples with babies born using ART choose to make their views on the technology that allowed them to be parents public. Moreover, none of the couples that had children using donor gametes informed their children of the fact. 1 This could prove problematic. It generates secrecy within the family and does not consider the children who can unexpectedly discover information that had been inaccessible to them. It also ignores possible genetic variance with the parents (assuming or disregarding genetic diseases). Additionally, given the advancement and the popularization of DNA tests, this attitude is almost anachronistic. Today’s babies will be adults in two decades, and genetic information is likely have made a huge impact by that time. Many countries have questioned the policy of secrecy, and instead favor reliable information. They reject the anonymity of donors. While Sweden (1984), Austria (1992), and the State of Victoria in Australia (1995) have adopted laws providing access to this information, Norway (1987) and Spain (1996) have approved anonymity. 2 These decisions reveal the difficulties this issue still faces at the international level. Also controversial is the number of embryos to be transferred per cycle. The United States privileges a successful conception and transfers about four embryos per cycle, which results in the high rate of thirty-eight percent multiple pregnancies. 3 This shocks European specialists who champion the transfer of one or, at most, two embryos. Their position should be understood within the framework of socialized medicine that offers the procedure at no cost. The percentages of multiple pregnancies differ across countries. They are characteristically quite low in Northern Europe, Australia, and New Zealand and high in

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Latin America, the United States, and Southern and Eastern Europe. European specialists focus on the difficulties of a multiple pregnancy and neonatal mortality. 4 They also consider the childrearing of two or more babies in societies with little and/or expensive help, and contemplate the economic and social costs for the health-care system, lengthy hospitalizations, and family problems involving premature multiple deliveries or babies with serious health impairments. Problems are relatively frequent in multiple pregnancies, and they increase concomitantly with the number of babies conceived. These and other questions generate intense discussions in the international debate, and are also relevant to Latin America. They coexist with other basic concerns that are linked more directly with the local context of these countries.

3. Limits and Their Criteria ART is often unregulated in Latin America. This means that the de facto experience of physicians working in ART carries much weight. One influence of the context can be seen in the way physicians restrict their use of ART, often denying options to couples in order to avoid reservations or social censure. The 1998 Surveillance Study, an international study on the latest practices in ART, only considers Mexico and Brazil to have some legislation. However, it would be erroneous to say that Brazil has national legislation, as The Brazilian writers Dirce Guilhem and Mauro Machado do Prado point out. At present, Brazil only has resolutions such as the Federal Council of Medicine’s, and is debating some bills. 5 These countries offer ART to married or de facto couples and allow embryo cryopreservation. Both countries permit the donation of gametes or oocytes. Brazil accepts surrogate motherhood so long as the woman is a relative. It does not accept, in principle, the commercialization of the procedure. In this sense, Brazil has one of the most “open” positions in the region. Costa Rica, in contrast, has a constitutional amendment that prohibits any kind of in vitro fertilization or donor artificial insemination. It only allows non-donor insemination, one of the simplest and least effective techniques. The problems of infertility must be quite minor for this technique to be successful, which consequently generates “reproductive tourism,” mainly toward Colombia. Countries with informal regulation (that is, without legislation) experience other problems. Because no explicit prohibition exists, assisted reproductive techniques are permitted. This is the case, for example, in Argentina, and in most of the countries in the region. One of the challenges physicians in these countries face—at the level of private practice—concerns the setting of limits. What are the proper limits for medical interventions? Should physicians provide single women with ART? Should homosexual couples have access? Is age a determinant? Are postmenopausal women eligible?

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The lack of legislation that establishes admissible and inadmissible uses of the techniques puts pressure on the “providers.” They must make decisions without the benefit of guidelines to establish parameters. The criterion is quite conservative in societies where the Catholic Church exercises a strong influence.. Any intervention that departs from the accepted norms risks criticism. The Catholic Church opposes these techniques. Yet, even less strict Catholics who accept new reproductive techniques contest some of the procedures or question who should have access to them (for example, single, post-menopausal women). Therefore, the physicians themselves have to “authorize” the practices. Within this context the influence of some ideologies generates a self-restricting attitude on the part of the physicians, who want to exercise their profession without upsetting the status quo. Establishing limits is a difficult task. Owing to the pressure of the context, setting limits is not a rational decision taken with specific criteria or reasoning. Religion plays a subtle role in defining who will ultimately have access.

4. “Mandates and Effective Practices” Some ART users view religion as an obstacle. However, only the strictest and most conservative religious people share this conception. Representatives of this extreme position are practicing Roman Catholics who object to any artificial technique (including the case of donor and non-donor insemination). They fall back on the inseparable link between union and procreation in marriage. Practicing Catholics cannot separate this bond. Religious positions also refer to the problem of human embryo manipulation. They consider embryos persons, and question embryo cryopreservation, embryo wastage during the different processes, and above all, the discarding of embryos. In Argentina and in many Latin American countries, strong ties exist between the Church and State, even though the constitution establishes freedom of religion. Something similar occurs in Bolivia, Peru, and Colombia. The Chilean, Ecuadorian, and Mexican constitutions are more “lax”—only referring to freedom of conscience. Brazil and Uruguay directly propose a secular State. 6 It would appear that religion should not be an obstacle to ART. 7 The devout undoubtedly must follow the teachings and the dogmas of their faith, but this does not imply that all citizens should be governed by these mandates. However, this is not how it works in practice. One problem lies in the Church’s attempts to impose religious dogma on the legislation of a secular country, as happens in several countries in the region. In this sense, it is understandable that Costa Rica’s total prohibition model is generating great concern. In the Argentine case, some bills are so restrictive that it would have been impossible to implement assisted reproduction techniques. With respect to the radical and absolute rejection of ART, consider the extensive application of a double moral standard. What religion dictates is one

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thing, but what people actually do is another. The large majority of the Catholic population (84.4 percent claim to be Catholic) does not follow the teachings of Catholicism. This phenomenon cannot only be seen in the case of ART; the same attitudes exist toward contraception and abortion. Chapter Four described Argentina’s restrictive abortion legislation. Abortion for serious genetic problems is deemed unacceptable. Nevertheless, illegal abortions are continuously performed. 8 Argentina has five times more abortions than France, where the practice has largely been legalized and the population receives suitable sex education. Regarding ART, the situation is quite similar. Zegers-Hochschild says: Specific instructions directed to legislators, health providers, and patients, containing these and other directives [against ART], have been vastly disseminated. Hence, it is difficult to understand how contraception, artificial insemination with donor sperm, and assisted reproduction can be so widely performed in the Latin American region. During 1995, 7,000 cycles of assisted reproduction including 351 transfer cycles with donated oocytes were performed in 59 centers throughout Latin America. 9 In the year 2000 the number of Latin American centers increased to ninety-five. At first glance, it would appear that ideological pressure is mitigated through the use of the double moral standard. It would appear that despite supposed social disapproval, some reproductive techniques are performed without much difficulty, but that is not true.

5. Double Moral Standards and Secondary Infertility Accepting or promoting a double moral standard is no solution. It has a harmful impact on reproductive health in general, and on assisted reproduction in particular. An analysis of the problem, leaving aside the context, may prove misleading. Let us consider the broader picture, such as the case of secondary infertility. This section will examine some basic issues that are often overlooked when analyzing ART in the Latin American context. (1) A lack of proper information and inadequate provision of contraceptive methods lead to a high rate of unwanted pregnancies and illegal abortions. Especially alarming is the number of teenage pregnancies. Countries like Brazil propagate the biased practice of early tubal ligation in addition to the above problems. Poor information and inadequate contraception later generate the need for infertility treatments. (2) Consider the great number of unsafe illegal abortions performed in extremely poor conditions, which carry a high cost for women’s health. Take the Argentine case, where forty percent of the hospitalizations in gynecological and obstetric wards in public hospitals result from complications during these

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abortions. In Mexico, 600,000 women required hospitalization for this same reason. An estimated 4,000,000 illegal abortions are performed annually in Latin America. 10 The high rates of maternal mortality that can be traced to abortions are also disturbing. Finally, unsafe abortions are not independent of ART issues. They constitute the cause of a large part of the infertility problems in the region. (3) The lack of sex education and contraception also leads to a large proportion of sexually transmitted diseases (STD). Such diseases are one of the most crucial sources of secondary infertility. María Yolanda Makuch, a Brazilian social scientist, cites a Brazilian study that reveals that forty-two percent of the women who request information about infertility suffer from tubal obstruction because of prior reproductive tract infections. 11 In addition, consider the taboos, the ideological problems, and the scarce resources in the public healthcare system that imply poor healthcare, and cause complications that result in serious infertility problems. Makuch describes the problems of inadequate information about STDs. The study points out that female respondents were unable to understand the relationship between prior reproductive tract infections and their present tubal infertility. Still worse, a comparison of the information the women remember receiving and what physicians report having supplied also suggests a widespread lack of understanding. 12 This suggests that the physicians themselves did not offer relevant information. This kind of infertility is not prevalent in industrialized countries. Latin America and Africa share high indices of secondary infertility, unlike Europe and the United States. While Europe and the United States register only a 24 percent rate of secondary infertility, Africa has a 55 percent rate and Latin America has 40 percent. 13 Undoubtedly its causes are correlated with the lack of resources and lack of respect for the right to reproductive healthcare. So, the solution does not lie in a double moral standard. Leaving aside the invaluable respect for women’s and couples’ informed decisions on conceiving children, current “survival” practices have high costs for women’s lives and health, for the public healthcare system, and for society in general. Lack of awareness about these kinds of problems and their relationship with assisted reproduction arises from an ignorance of the context. Situations that, at first glance, appear unrelated, like suitable education and reproductive healthcare, impact on assisted reproduction. Also consider how the resolution and response to “boring problems” (reproductive healthcare) influence “provocative problems” (ART). This reveals how these problems are interrelated. The occurrence of fundamental changes will not depend solely on the implementation of sophisticated techniques, but on prevention, respect, education, and care for reproductive health.

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6. Embryos and Persons The preceding section described the lack of respect for women and couples in their reproductive decisions that is manifested in a failure to provide them with proper information and effective methods to exercise their reproductive choices. Another correlated aspect is the status of the embryo in the region. An element that cannot be overlooked is the importance afforded to embryos, often to the detriment of the woman herself. The “priority” of embryos is subtly present in some attitudes, in the terminology used, and in some practices that determine and covertly limit a woman’s or her partner’s options. Consider four attitudes and practices that occur in some assisted reproduction centers in Argentina: (1) the refusal to freeze embryos when no law impedes it; (2) the obligation to donate embryos; (3) the term “prenatal adoption”; and (4) the paradox of introducing prenatal genetic diagnosis, when embryos cannot be discarded. The first issues are related to possible limits or harms involved in protecting the embryos over the welfare of women. To evaluate point (1) it is necessary to clarify the logic of the procedure. The most complex techniques like in vitro fertilization or ICSI fertilize the oocytes ex uterus and then transfer them to the woman. The process requires controlled ovarian hyperstimulation to obtain several oocytes, a laparoscopic or a vaginal technique, with which the embryos will be retrieved. The technique of cryopreservation or freezing embryos was incorporated to avoid having to submit women to this procedure several times.. (The oocytes are quite fragile and the cryopreservation process is still being developed). In this way the best embryos are selected and transferred to the woman. The current European tendency limits the number of embryos for transfer because of the high percentage of multiple pregnancies. They propose transferring only one or two embryos. Remember that the success rate of these techniques is not high, and the process must often be repeated for several cycles to achieve pregnancy. Despite a consensus on the importance and the benefits of cryopreservation, many Argentine fertility centers limit the number of embryos that are to be frozen. We see a decreasing trend in the number of embryos the centers freeze. Their aim, it seems, is to deal with fewer embryos, and so avoid problems with the status quo. The consequence of such an unwritten policy is that women must submit themselves to more frequent hyperstimulation treatments with hormones and medications, with the resulting inconvenience and the harm this implies. Even though this harm may occur only rarely, its is serious enough to warrant its avoidance wherever possible. Possible harms include Ovarian

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Hyperstimulation Syndrome, as well as a possible increase in the risk of ovarian cancer. 14 A second issue is that, in general, surplus embryos cannot be discarded in Latin America unlike most industrialized countries. The only possible alternative Argentine centers offer—when a person does not choose to use the remaining embryos—is to donate them to another couple. That is, this “induced donation” is virtually an obligation, which can involve serious psychological harms and can be especially painful when the donor herself cannot become pregnant. A third consideration arises with the practice of “embryo donation,” currently termed “prenatal adoption.” Terms have much weight. They imply an interpretation of facts. The expression “prenatal adoption” is misleading and conveys the idea of an actual adoption. It is not a bias-free term, much less in a region that often privileges the embryo over the woman. With this term, embryos are treated as orphans, an analogy that leads to some paradoxes. If we grant embryos the condition of persons, the cryopreservation process could prove, at the very least, puzzling. How can we freeze persons? In addition, in vitro fertilization could be interpreted as a massacre because of the loss of embryos in the process of transference to the woman’s uterus. The practice itself of “giving them up to adoption” (with the obvious intention of protecting the embryos) could imply embryo death or destruction, due to possible loss or difficulties in the transfer. The term is quite problematic and warrants review. A final problem is related to the health status of the embryo and the prohibition of abortion. While the International Federation of Fertility Societies encourages screening for serious diseases that can threaten the health of the child, many Latin American countries do not accept the elimination of surplus embryos or abortion. Brazil, in this sense, is the exception. 15 Countries that prohibit the disposal of embryos, even in the case of genetic anomalies, face another paradox. This is the case with Chile and Argentina. Embryos that have been tested and proven to have serious genetic problems must still be transferred (because they cannot be discarded). Centers claim that they do not discard embryos. This leads to the nightmarish situation of a woman having to accept the embryo transfer and possible pregnancy, knowing her future child will suffer from a serious or even fatal disease. Consequently, we can consider two proposals. One prohibits preimplantation genetic diagnosis, which could be harmful to the couple and the future child, especially if the procedure is to prevent the transmission of a genetic disease. Or, preimplantation genetic diagnosis is made and embryos with genetic problems can be discarded. However, most fertility centers reject the second option. This reveals another example of hypocrisy and the double moral standard. It implies possible harm to the couple or the child given the embryo’s status in the culture. The above cases show how the welfare of embryos is subtly privileged over women and couples. Some of these procedures can increase health risks

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for women, produce psychological harms, foster misunderstandings, or limit the chances couples with genetic problems have of conceiving healthy children.

7. A Problem of Reproductive Healthcare In light of the above, this analysis concludes with a reflection on the healthcare structure in which these techniques are applied. Several consider this a problem for the middle- and upper-class population, or for professional women who have put off having a family. This may be the dominant model in industrialized countries. However, as we have seen, Latin America shows a strong prevalence of “secondary sterility,” which is associated not with the powerful classes, but with the poor. This means that the population in need of ART differs greatly from that in industrialized countries, so the healthcare model should be quite different. Serious problems exist in education and in reproductive healthcare that call for preventive policies to be established. It is necessary to overcome the forty percent level of secondary infertility and this can largely be achieved with suitable preventive methods. In this sense, we cannot merely reproduce highly sophisticated clinics. Latin America’s response must be broader. It must begin with a suitable STD prevention program and appropriate sex education so as to deter the huge number of unsafe illegal abortions and their complications. If Latin America is to make use of preimplantation diagnosis, it should also at least include severe genetic diseases or malformations as grounds for legal abortions. This approach to the issue calls for an all-embracing perspective that includes infertility prevention to avoid greater harm to poor women, who are already excluded from any kind of treatment. This conception considers the costs of the procedures, the lack of resources in the region, and the percentage of sterility resulting from inadequate services or insufficient attention in the area of reproductive healthcare. The resolution of “provocative problems” in Latin American countries is strongly correlated with “boring problems.” This proposal implies making a commitment to a comprehensive solution. That ART in Latin America is a totally different issue from basic reproductive healthcare appears to highlight a schizophrenic model. If contraceptive services are denied, if STDs in men and women are improperly cured, if embryos become the objects of worship, if abortions for serious genetic disorders are prohibited, and if we only focus on the provision of the latest technologies in assisted reproduction, we lose sight of an essential point. ART is not independent of its context. The procedures are the result of scientific effort. However, they are quickly adapted to the standpoints of some ideologies. Euphemisms help avoid pseudo-moral or religious critiques and thus maintain the status quo. It is unhealthy to preserve such a hypocritical stance. Those working in ART

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should propose a broad and integral approach to assisted reproductive technologies with a deep commitment to all individuals’ reproductive healthcare.

Seven SOCIAL SCIENCE RESEARCH AND RESPECT FOR PERSONS 1. Introduction The remainder of this book examines ethical concerns in research. This chapter considers, specifically, research in the social sciences. Ethics in social science research constitutes an area of analysis that has largely been overlooked. A review reveals some fundamental issues in research ethics and the lack of respect for research subjects. The following chapters approach the classic problems of clinical trials, and consider the case of AIDS in particular. Chapter Eight presents different proposals for modifying the ethical codes and documents used in research. It explores the early problems researchers tackled, as well as some of today’s questions. Chapter Nine studies the placebo discussion, the Zidovudine (AZT) cases that fostered the introduction of changes into the codes, and the introduction of post-trial obligations. The last chapter presents an analysis of systemic corruption and its possible impact on research, especially international research.

2. A Structural Problem This chapter focuses on some of the problems that arise in many Latin American countries when analyzing research in the social sciences. It highlights the tendency to avoid informed consent. A common belief is that social research deals with less controversial and risky research than biomedical research. So, if the chapter shows the relevance of respect for research subjects in social science studies, and makes the case for respect for such subjects, the point will become even more pertinent in the case of biomedical clinical trials. We consider research in the social sciences a study fundamentally in the fields of anthropology, sociology, or psychology. These studies involve, for example, observations, questionnaires with open-ended or closed questions, interviews, and follow-up of case histories. The themes can be quite broad: behavioral studies, the analysis of why women with abortion- or cancer-related problems do not receive proper treatment, contraceptive-related behavior in specific communities, or the factors that lead to repetitive or destructive behavior. The chapter is based on a series of actual cases that Latin American researchers have presented centering on reproductive health, 1 which explains the

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kinds of examples drawn upon. For instance, some of the research consisted of identifying, describing, and analyzing the meaning that teenagers from popular neighborhoods ascribe to their pregnancy and the context in which they live. 2 Other studies analyze the negotiation process between women who have undergone illegal abortions and public-hospital physicians (women tend to deny they have had abortions for fear of legal prosecution). Other research focused on their reproductive health, and the incidence of ovarian cancer: The specific aims of the research were: (a) to quantify and to qualify the losses of patients with positive Papanicolaou studies (PAP); and, (b) to examine the possible causes of this phenomenon. In addition, the research explored the quality of the information that women have about the PAP, the manner in which healthcare providers and patients communicate and the content, and the kind of care patients receive. 3 Let us first examine some of the factors that impede the application of some ethical principles and then analyze the suitability of promoting changes in the behavior of researchers. One problem is that of working ethically in countries where ethics is elusive. The fieldwork can generate difficulties: the signing of informed consent forms, access to case histories, reports of illicit behavior, or the invasion of research subjects’ privacy. Nevertheless, one of the most relevant problems in social science research is the lack of awareness of an ethical dimension associated with valuing and respecting persons. This principle, handed down from the Kantian tradition, indicates that individuals must be treated as autonomous agents and that persons with diminished autonomy have the right to protection. 4 Attitudes about respect for persons are manifested in a variety of different ways. One way is to treat the subjects as adults with full decision-making capabilities. In the case of research in the social sciences, this means explaining and requesting voluntary participation in a project, offering reliable information, or the standard signature on a document, as in informed consent. Such documents can sometimes be excessively intimidating, and of a legal rather than an ethical nature. Many research studies overlook this precaution, viewing it as superfluous, and believing it to encumber the research. A well-known researcher in the field admitted that she had told her students to ignore informed consent when they conducted their social research. 5 The lack of awareness about respect for persons appears to be a structural problem, as it has been observed in male and female researchers, physicians, research subjects, and patients. The first part of this book described the lack of respect and authoritarian attitude toward illiterate patients or women. This lack of awareness spans virtually all strata, and is in part due to social science researchers receiving little or no ethical training. In general, this ill prepares them for the analysis of legal and deontological facets of their work. Social

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history is also relevant (for instance, long years of dictatorship and authoritarianism). Lack of respect among some social researchers is not necessarily a position of personal indifference. Several social researchers who have presented problematic cases began their training in more recent years, attending seminars in bioethics and showing a sincere concern for ethical problems. Ignorance of ethics in healthcare and research is gradually disappearing. However, a general unawareness of some questions still exists, and demands consideration. Identifying an ethical problem can sometimes produce pressing personal conflict that ultimately interferes with the research. These conflicts are often deemed to be subjective and weigh on the researcher’s mind. They appear to be incongruent with the “objective” implications of research.

3. Information and Vulnerable Populations In analyzing the case of informed consent in the social sciences, we have to consider the information researchers must explain to the research subjects: [. . .] the aim of the research, the methodology of the research, the possible risks, the expected benefits and alternatives, and how the information will remain confidential. Additional information that must be provided is that the research subject can withdraw from the research whenever he or she chooses; if the research subjects are patients, they can leave without risking their current or future treatments in that hospital or clinic. These last requirements refer to the voluntariness of participation. 6 Even if informed consent is not an absolute condition, a general consensus supports it. 7 However, special or difficult situations might arise in the case of the social sciences, such as: [. . .] those cases in which the researchers study people without ever telling them that they are being used to that purpose. In this situation, researchers are not only violating the requirement of informed consent but also invading the privacy of these people. An example of this is the use of hidden cameras to obtain data. 8 A similar example is the observation method where the researchers may “deceive” research subjects in order to conduct the research. (Cases exist of researchers using actors or specially trained persons to simulate a situation, and then observing the reactions and attitudes of the research subjects). 9 Social science researchers and bioethicists may disagree on the correct procedure in these special cases. 10 This chapter examines less controversial cases. Nevertheless, informed consent is difficult to obtain as the research subjects are the illiterate poor and

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vulnerable. What reasons justify not offering them information about the nature and consequences of the research, and not explaining their right to withdraw from the trial, or their right not to participate in it? In the reproductive area, most research is conducted among poor women, a vulnerable population coming mainly from public hospitals. Is it possible to justify the belief that this population does not need adequate information? The socio-economic factor itself is not a satisfactory rationale as it offers no ethical justification. The socio-economic argument generally falls back on the lack of education in poor populations. Chapter Three illustrated that a deficient education is not tantamount to implying an individual lacks the faculty to understand. Researchers can explain the procedures to the patients and clarify the rights of female patients—their right to withdraw at any time or to refuse to participate. Informed consent, on the other hand, must be drawn up in easily understandable terms. This goes beyond the difficulties of signing or not signing an informed consent request. If it is not a problem of comprehension or the lack of capability, women should be able to understand the objective of the research and their rights as research subjects. Otherwise, they would not be receiving adequate informed consent. This is what should happen. But even if, hypothetically speaking, this population cannot actually understand what is happening, or even if the participant cannot withdraw from the research at any time, why is it so essential to work with this group of persons? Can the research be conducted any other way? Is working with poor women indispensable, or is it simply easier? If this vulnerable population cannot understand what benefits them or if they are indifferent to the research, does it make any sense to use them? In light of this vulnerability, who will protect them? Fear that the potential subject will refuse to participate is another supposed justification for not explaining the objectives of the research or the rights of the research subjects. However these grounds are invalid. The prospective participant’s refusal must be respected as a right. It also worth noticing the propensity to use arguments stressing future benefits without consideration for potential harms. Researchers often emphasize future benefits for some persons, for some social strata, or for humankind, and relegate the specific individual. This kind of argument, quite common among scientists, must be employed carefully, above all in cases of nontherapeutic research. It is commonly held that social science research is innocuous or harmless, and this is not necessarily the case. Some research explores painful and possibly traumatic experiences, such as abortions, illnesses, and the loss of close relatives. The research can bring back upsetting memories and cause psychological distress. It is up to the participants to decide whether they will submit themselves to research that will benefit “humankind.”

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4. Other Possible Justifications In the social sciences, much research targets patient populations (AIDS patients or women with diseases like cancer). Some research focuses on possible patients (teenage groups). Other research examines the medical team and their relationship with particular patients. This was the case with an anthropologist studying the interaction between pregnant women with Human Immunodeficiency Virus (HIV) and their physicians during pre-natal care. The social researcher herself pointed out the difference between the attitudes required toward the “physician-research subject” on the one hand, and toward the “woman-research subject” on the other. Historically, the public hospital has been the place for learning and practicing medicine. We learn medicine from the bodies of the poor. And more recently social sciences have been incorporated into research in hospital institutions. In public hospitals, the body and the intimacy of the patient are public, as well as the medical work, which can be observed, for example, by anthropologists if the authorities of the hospital allow the research. 11 The same researcher explains how informed consent is obtained in the case of the physician-research subject. First, we could say that there is an institutional informed consent (protocol submission, hierarchical authorization), without which we would not be allowed entry. But, at the same time, this institutional informed consent conditions the physician’s informed consent. Although we explained the aims of the research in detail in each case, and even offered a copy of the research protocol upon request, the possibility of obtaining an interview or being allowed into the physician’s office or the delivery room depended on prior hierarchical authorization. 12 She also explains her feelings regarding the informed consent of women. They could refuse to be interviewed; in fact, some of them did not come to the appointment, which could be understood as a refusal of the proposal. But those that accepted devoted many hours out of their lives for us, speaking about their private life and their suffering. Consent was not so much an act that the interviewed women recognized. To the contrary, if they signed, it would appear to be a request to release the researcher of responsibility. 13 There appears to be a great disparity between the processes regarding the “woman-research-subject” and the “physician-research subject.” Physicians are

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informed about the research, usually notified, and their superiors oversee the research. They sometimes claim that they too have been deceived or do not recall having been consulted—which probably means they have not participated voluntarily. 14 However, as participants, physician-research subjects receive greater respect. The institution protects them because it must grant permission and release details about the content of the research and how it will benefit the authorities of the hospital before any study can be conducted. 15 Why does this difference arise? Despite the structural problem in the lack of awareness about some ethical questions, the disparity in treatment between different kinds of research subjects is striking. One response points toward problems of justice and the unequal circumstances of the poor attending public hospitals. However, that a socially unfair situation exists should not be seen as justifying depriving these patients of respect. Another problem linked to the hospital context and the difficulties researchers must confront in their daily practice could help explain some attitudes. This chapter focuses on a subtle implicit element that is often present when social researchers work with physicians in hospitals. From the start, social science researchers must cope with some asymmetries and injustices that have nothing to do with the research subjects, but with the researchers themselves. They do not enjoy the same “hierarchy” as physicians. In addition, they have to go to the hospitals (the domain of the physicians) and “request permission/collaboration” to conduct research. They have to accept the “rules of the game” that the health-care professionals impose: wearing white coats or developing the research-subject relationship through the doctor. They must interview the physician’s patients, sit in during the physician’s appointments, and go to the physician’s institutions. That is, they need the support and collaboration of the physician. Of course, any research conducted in an institution to which the researcher does not belong calls for a compliance with institutional guidelines and regulations. Nonetheless, it would appear that institutions that are as hierarchical and vertical as hospitals curb a researcher’s freedom to act. Contrast this asymmetry with the situation in other institutions. The researcher quoted above compared this circumstance with those encountered in educational settings (for example, research in schools or universities), and recognized differences. Researchers in this field may need collaboration. However, these institutions make it easier for researchers to act on their own convictions, because the relationship is more uniform with the teachers and professors. The subtle asymmetry that is perceived in hospitals or health-care institutions often inhibits social researchers. Yet, does this element play such a fundamental role that it justifies adopting different attitudes toward research subjects? Physicians have to work together with the researchers, show them case histories, and allow them to sit in on appointments. Patients, who are asked to attend interviews and respond with sincere answers, collaborate as much as physicians. The asymmetry does not apparently lie in collaboration itself.

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Is the question of time an impediment to informed consent in the medical setting? In general, public hospitals are crowded with patients and overburdened physicians, and so time becomes a precious item. Some of the research is conducted with pregnant women. It takes time to explain the objectives of some research and to see if the research subject understands or can aptly answer the questions. Appointments last only ten minutes on average. Another issue is informed consent prior to delivery. As the delivery room is certainly not the most propitious setting or moment, such communication should take place during earlier visits to the clinic. Sadly, this is not always possible. In such cases, the patient’s very condition acts as an obstacle to communication, which, in turn, can interfere with the objectives of the research. Researchers must find a way to conduct their research without hindering the work of the physician. These restraints can be quite difficult to modify and the researchers are not there to promote changes. Nonetheless, the above factors are no justification for not requesting informed consent.

5. Foreign Values? The above sections referred to how unaware some social researchers are about the need to respect research subjects and their rights. Is the notion that research should incorporate new attitudes and involve informed consent an acceptable guideline for Argentine or Latin American social researchers? Does this proposal merely extrapolate some criteria that only function in Anglo-Saxon societies? A common objection to informed consent tries to discredit consent. It claims that these criteria correspond to the North American model and are inapplicable in the South. But, how true is this? The following demonstrates that this concept is not at all foreign to the “Latin American culture.” We will examine some of the landmarks in biomedical research, the dangers of some abuses, and the relevance of international codes that specify the importance of respecting the basic rights of research subjects. The Introduction to this book explained the heterogeneity in developing countries, even among Latin American countries. Because of this, let us focus on the Argentine situation. First, Argentine culture, above all, reflects a strong European influence. Notions such as that of the need to respect human rights are not alien, despite an unfortunate history of authoritarianism, de facto governments, and dictatorships. Despite this tragic and regrettable history, which Argentina unfortunately shares with many Latin American countries, the Argentine vision of how societies should function and of what parameters are to be respected has deep European roots. These are not values questioned per se, unlike in some Asian countries, which find that the European notion of human rights makes little sense, and call for a theoretical defense of those rights. Hyakudai Sakamoto says:

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BIOETHICS AND VULNERABILITY: A LATIN AMERICAN VIEW In many countries to the east and south of East Asia, the sense of “human rights” is quite weak and foreign, and they do not have a theoretical base for the concept of human rights.

Such societies apparently do not share the modern Western ideas of “person” or of “human dignity” found in eighteenth-century Western philosophy. 16 This chapter will not examine the classic universalism-relativism debate. Even if we concede that human rights or respect for persons holds a different value in other societies, Latin America, and especially Argentina, does value and does accept the concept. Nonetheless, it has not been adequately adopted in some social research. Second, a common erroneous interpretation in the argumentation based on rights should be noted. Rights are quickly identified with the principle of autonomy as found in the North American cultural model. However, an obvious European tradition points to the importance of some rights. Consider Locke’s contribution regarding negative rights—the right to life, to health, and to freedom—or Kant’s view of the importance of the moral subject as an autonomous agent: An agent must never take other human beings as mere means for some external purpose, but as ends in themselves. Neither can we claim that the declaration of human rights is identifiable with the United States, much less the codes protecting research subjects. International declarations like the Declaration of Helsinki or that of the Council for International Organizations of Medical Sciences (CIOMS) 17 currently establish guidelines for research.

6. Abuses in Biomedical Research Third, let us analyze some milestones and arguments used in biomedical research and see how they relate to the social sciences. History shows repeated abuses in research in which selected groups came from the most vulnerable populations: mentally ill patients, the elderly, and prisoners. In the eighteenth and nineteenth centuries research was basically therapeutic, was conducted on a small scale, and its ethics was consistent with that of the community. Experiments were carried out on offspring and neighbors. The researcher Dr. Edward Jenner, exemplifies the style and technique of research against smallpox that predominated for the following 150 years. In 1789, he inoculated his one-year-old son with an experimental substance. As from 1935, with the introduction of sulphonamide, research began to be conducted in hospitals. The drug was given to small groups of patients and physicians compared recovery levels with those of similar patients or patients who had not been given the drug. 18 When the application of medicine turned more scientific, medical advancements began to promise a future without illnesses. During World War II

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experimentation underwent a transformation, especially in the United States. Between 1941 and 1945 the government financed a well-organized extensive national research program. Here, an interesting change in attitude can be noted: Instead of benefiting the patients, the proposal was now to benefit others, the soldiers at the front. Researchers and research subjects became mutual strangers, and the consent of the subjects was overlooked out of a sense of urgency. The rights of the participants were clearly ignored in research concerning dysentery, malaria, and influenza. During World War II, a mixture of arrogance and caution existed in the field of medical research. The Committee for Medical Research, which evaluated when research would be likely to produce an adverse public reaction, ensured that researchers operated with caution. Arrogance, however, was manifested in experiments such as the following. Dysentery on the battlefields was of great concern. As no vaccine or treatment could be tested in combat zones, orphans between the ages of thirteen and seventeen were selected from the Ohio Soldiers and Sailors Orphanage. The research team alternately injected the children with several substances (subcutaneous, intramuscular, or intravenous). All of the experiments had acute side effects (high fever, severe headaches and backaches, nausea, vomiting, and diarrhea). While the children appeared to develop immunity, the vaccine was not used precisely because of the side effects. Although the project could not develop a safe vaccine, the researchers were optimistic and later revealed that they had used extremely high doses to ensure substantial results. That is, they had raised the doses to demonstrate the strength of the agent, without concern for the welfare of the children who developed the side effects. 19 Experiments were carried out on participants with mental disabilities, patients, prisoners, and soldiers. In wartime, the value of consent diminished. Using incompetent individuals presented no concern to researchers. 20 Just as some faced bullets, others had to receive injections and test vaccines. The researchers advanced teleological positions. “The greatest amount of happiness for the greatest number” in this case justified sending some persons to their death so that others could live. Their view was that the ends justified the means, and that they could justifiably select martyrs in the name of science. This peculiar approach to research in wartime was maintained during what came to be known as the gilded age of research: non-existent informed consent, the absence of voluntary participation, the triumph of laissez faire in research. The dogma stated that medicine: [. . .] appears to be approaching the threshold of a brilliant new era of discovery in which some of mankind’s most dreaded diseases may be wiped out. 21 And when it was not a case of “mankind,” it was one of “national security.”

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During this stage the only cases that required formal approval of research protocol involved research on normal healthy persons. Consent was considered an empty ritual. 22 The collective impression was one of skepticism: a disregard for codes or rules. The researchers alone were accountable. The Nuremberg Code (1947), despite its force and clarity, was not so influential in the United States. Nazis had committed those atrocities and that they were Nazi physicians and researchers was overlooked. The Code was considered a document that did not concern respectable researchers. In 1966, the North American anesthetist and researcher, Henry Beecher, published an article 23 describing twenty-two research projects risking the life or health of the participants. Awareness began to emerge about basic rights in all research. Beecher’s second example describes men who were infected with streptococcus and were intentionally not given penicillin, in order that alternative treatments could be studied. The men were unaware that they were participating in an experiment that exposed them to rheumatic fever (twenty-five fell ill). Example sixteen consisted of giving live hepatitis viruses to retarded patients in a public mental institution to study the etiology of the disease and to develop a vaccine. In example seventeen, physicians injected twenty-two senile elderly research subjects with live cancer cells to study the body’s immune reactions. The patients had not been informed that the cells they were being given were cancerous. These are not alien values, not even for research during World War II. In 1830 an English commentator said: But if the practitioner performs his experiment without giving such information to, and obtaining the consent of his patient, he is liable to compensate in damages any injury which may arise from his adopting a new method of treatment. 24 Even before 1833 William Beaumont, a physician conducting nontherapeutic research, maintained, among other points, that voluntary consent is necessary and that the project must be abandoned if the participant is harmed or dissatisfied. 25 The French physician, Claude Bernard, in his celebrated text An Introduction to the Study of Experimental Medicine says: It is our duty and our right to perform an experiment on man whenever it can save his life, cure him, or gain him some personal benefit. The principle of medical and surgical morality, therefore, consists in never performing on man an experiment which might be harmful to him to any extent, even though the result might be highly advantageous to science, i.e., to the health of others [. . . .]” 26 In Germany, where science had achieved a level of excellence, rules about research and the need for consent had been in practice since 1900. On 29

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December 1900 the Ministry of Religious, Educational, and Medical Affairs of Prussia established the prohibition of non-therapeutic research in minors and incompetent participants (protecting vulnerable populations). It also established that the person in question had to unequivocally consent to the intervention, and that his or her agreement needed to be based on an adequate explanation of the adverse consequences that could arise from the intervention (a far more refined notion of the protection of persons than in previous documents). In 1931 the Ministry of the Interior proclaimed a crucial and progressive regulation about biomedical experiments on human beings as a result of the deaths of seventy-five children stemming from experimental tuberculosis vaccines. 27 Despite this history of abuses and the lack of respect for some guidelines, respect for persons and informed consent were present not only in the reports by eminent researchers during the nineteenth century, but in the Beaumont or Nuremberg Codes.

7. The Weight of Ethical Codes Fourth, let us seriously consider the weight of some ethical codes. In 1947 the first article of the Nuremberg Code clearly referred to the voluntary consent of the participants and the possibility of their withdrawal from the research at any time. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. 28 This article was judged too strong and later declarations like Helsinki and CIOMS have made it more flexible. Article nine of the Helsinki Declaration says: In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits, and potential

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BIOETHICS AND VULNERABILITY: A LATIN AMERICAN VIEW hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from the participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The physicians should then obtain the subject’s freelygiven informed consent, preferably in writing. 29

In 1964 the World Medical Association (WMA) adopted the Declaration of Helsinki (later reformed several times). It also stipulated that the research protocols should be presented to an independent Committee. As a result of the evaluation of risks and benefits it clarifies: Concern for the interest of the subject must always prevail over the interests of science and society. 30 In the Declaration of Helsinki, informed consent is no longer the main focus of attention. Minors or the incompetent can participate and the legal tutor or the parent is responsible for giving informed consent. The International Ethical Guidelines for Biomedical Research Involving Human Subjects established in 1982 by WHO and CIOMS gives special treatment to the situation of vulnerable populations and groups in developing countries that did not understand the repercussions of their participation in some research. In the 1993 version of the CIOMS document, the requirement of informed consent becomes even more flexible and allows for obtaining informed consent via a respected community leader. The Guidelines stress that the intermediary must insist that participation is not mandatory and that any participant can abstain from participating or withdraw at any time. 31 However, even if the 2002 version of CIOMS accepts the introduction of a community leader, council of elders, or another designated authority, it explicitly says that in no case may the permission of a community leader or other authority replace the individual’s informed consent. 32

8. The Social Sciences and Research Biomedical experiments can mean injecting patients with substances that could harm or even kill them. This cannot happen in social science research. Why, then, should we consider the chronicle of biomedical abuses and existing codes? One reason is that the clinical account of negligence and irregularities reveals quite plainly some of the all too common problems in research: for example, inadequate processes of informed consent, exploitation of vulnerable populations, and dubious justifications for unacceptable research that had not been conceptualized as such at the time. Although the Codes and Declarations were basically designed for medical and biomedical research, they include guidelines that should be kept in mind for other areas of research.

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What attitudes manifest a lack of respect for participants in social science research? We have already identified the lack of adequate informed consent, deviousness in offering information (not advising the participants that they can withdraw from the trials), manipulation to achieve participation in some research. We can also find ethical problems in the inadequate explanation of risks and benefits. Granted, a great difference exists between biomedical research and research in the social sciences. The harm occurring in the first can be more direct and fatal, while the second is less visible and explicit, as well as less probable. At first glance, this could imply that the above reflections are inapplicable to the realm of the social sciences. Yet, even if the focus of the research differs, some social science research can generate harms, such as those dealing with stigmatizing diseases (AIDS, mental illness, or sexually transmitted diseases) or reproductive problems (sterility or abortion). 33 It can evoke in its subjects memories of intimate, painful, or taboo experiences (for example, abortions and unwanted pregnancies). Research can also trigger feelings of guilt and probe into violent actions or anguishing sensations. In other words, it may not necessarily be innocuous to the participant. Nonetheless, even if no harm were to occur, Nuremberg explicitly established respect for participants and their rights. These persons are freely and voluntarily helping others. Of course, they may want to take part in the research out of a desire to help others or because they feel it will benefit them in some way. But ultimately, they themselves must decide. The underlying idea of a person’s free choice is fundamental and is a crucial element in medical research. We have to consider whether a person’s privacy has been invaded by research, in addition to ensuring the confidentiality of the information. Biomedical research is far more aware of this point and maintains a tradition of respect for it. Another interesting element is justification. Although arguments of a teleological nature justify some actions, we have to avoid the dangerous situation that occurs when the values of “science,” “knowledge,” and the “good of humankind” take precedence over persons. Individuals are not guinea pigs. We should remember that most abuses have occurred among the vulnerable: the elderly, the mentally deficient, the poor, and the illiterate. For that reason, the history of abuse in research distinctly reveals the significance of respect for persons, the relative import of knowledge, and the relevance of how it is obtained. Based on this, respect for the research subject is a guideline to be upheld in all research, including in the social sciences.

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Eight AIDS, RESEARCH, AND ACCEPTABLE CODES 1. Introduction Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) is a disease with ethical impact. It embodies a number of ethical problems (for example, discrimination, confidentiality, privacy, individual rights versus collective rights). Chapter Five explores the problems infected women face in exercising their reproductive rights. Research has not remained aloof from this pattern. This chapter evaluates the changes AIDS has introduced into ethical standpoints concerning research subjects. It focuses on some of the questions the phenomenon of AIDS presents to established guidelines in ethics with research subjects. Two sets of objections have been advanced to research. One was presented at the onset of the epidemic in industrialized countries when the first drugs were being tested. The other, which emerged in the late 1990s, was advanced when research turned global and an effective treatment had been developed. In order to work toward an understanding of the differences between these two sets of objections, the chapter will examine what occurred in industrialized countries first, and then analyze the situation in the South. The first part of the chapter, therefore, analyzes the onset of the AIDS epidemic and its impact on research. Early research was largely conducted in industrialized countries. Most critiques of the reseach were advanced by young middle-class men, AIDS activists living in the United States. A fundamental problem is whether the issues resulting from the emergence of AIDS undermine the standpoints of Codes of Ethics like the Nuremberg Code and the Declaration of Helsinki. Another question is whether the new regulations triggered by AIDS imply a paradigm change à la Thomas Kuhn. In answer, the chapter describes some of the landmarks in research and the principles assumed by the Codes of Ethics. Many of the objections raised at the onset of the epidemic were solved without having to modify traditional ethical codes. Yet, the “globalization” of research poses new problems, some of which threaten these documents. The second part of the chapter examines current questions, as well as the impact some modifications can have on ethical codes in research and on vulnerable populations of developing countries.

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The previous chapter explained how research involving research subjects in the nineteenth and early twentieth centuries was conducted on a small scale: in families or with neighbors. The advent of new drugs like sulphonamide and attempts to find vaccines—for example, the anti-malaria vaccine— brought other problems to light. 1 Following the Nazi atrocities, the Nuremberg trials ended with the proposal of ten ethical standards. These came to be known as the Nuremberg Code. Years later the World Medical Association (WMA) formulated the Declaration of Helsinki. Since then, society has gradually become aware of the need to protect research subjects. In the late 1970s these Codes became more widely accepted. New protection norms have since been designed not only to terminate a long history of abuses, but to avoid harms resulting from hasty decisions. What points do these ethical codes raise? Codes and Declarations do not contain a consistent theory of normative ethics. Even though they are ostensibly instances of applied ethics, they have more to do with the empirical pressures of research than with coherent normative proposals. In addition to these underlying problems, they differ from each other. For example, the Nuremberg Code gives far more weight to informed consent than the Declaration of Helsinki. Even if they differ, the Codes promote: x the need to respect voluntary consent (afterwards called informed consent); 2 x the human subjects’ understanding that they can withdraw from the investigation at any time; 3 x a careful risk-benefit analysis (“Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others”); 4 x an appropriate elaboration of research protocol based on prior investigation in the laboratory and on animals; 5 x approval by an independent organization (ethics committee or another). 6 Undoubtedly, the spirit of the Codes and Declarations is to protect vulnerable populations such as soldiers, prisoners, children, and persons with mental disabilities, among others. This falls back on the principle of respect for persons. 7 The Codes also guarantee that necessary precautions have been taken and these populations are protected from controversial research. Has the AIDS crisis challenged these documents?

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A. Codes and Agencies Research subjects rely on diverse kinds of protection. The Codes of Ethics promote the consideration of ethical standards. A country’s agencies or federal institutions implement regulations and safeguards. The following section analyzes the roles of a United States regulatory agency, and the problems it faced. The development of drug research is linked to some agencies or institutions that monitor research, and protect research subjects and the population in general. To differentiate between what the Codes say and what the agencies and their regulations understand by protecting the patients, we should first distinguish between two levels of analysis: the regulatory role of the Codes as promoters of specific principles; and the agencies or regulations that attempt to implement or to interpret those principles. Critiques of the agencies do not necessarily affect the Codes if the latter are not interpreted correctly. Since the onset of HIV/AIDS, the Food and Drug Administration (FDA) has faced strong and fitting criticism over the way in which it has worked with drugs. Criticism has also focused on the ethical parameters that research with human subjects demands. Specific objections have focused on the time the FDA has taken to approve certain drugs, the lack of distinction between different drugs, and the potential of those drugs to cure or alleviate terminal or serious illnesses. For example, until 1980 the FDA’s average approval time was twenty months once clinical trials had ended. Between 1986 and 1989, the approval time of the most urgent drugs averaged 27.1 months. The 1982 McMahon Report says that the development process of drugs (from the moment they are synthesized to the time of approval) averages thirteen years. 8 Another criticism centers on the harm experienced by North American patients who could not access drugs accepted in European countries. These points were undeniably valid and targeted serious problems: barriers in research, bureaucracy, FDA inefficiency, harm, and lack of protection. Such criticisms generated specific changes in FDA policies. In May 1987 the Investigational New Drugs (IND) Treatment regulation was approved. This regulation allows patients with serious or life-threatening diseases to purchase drugs that are still under investigation. 9 In October 1988, the regulations of Subpart E were approved. They allow the FDA to participate in the planning of clinical trials for diseases like those mentioned above to accelerate their approval. The development process of drugs has at least three phases. Phase I involves ten to fifty research subjects. It examines how they tolerate, metabolize, and eliminate the drug. Phase II includes fifty to two hundred research subjects and tries to establish the drug’s effectiveness. Phase III extends to one thousand or more participants, and studies the drug’s safety and effectiveness. Prior to these regulations the FDA showed a mistrustful and antagonistic attitude toward pharmaceutical or drug companies. Subpart E implied a collaborative attitude in the interests of achiev-

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ing better results more quickly, and the possibility of combining the tests during Phases II and III for approval. In 1992 Subpart H (regulation for accelerated approval) was approved. This new regulation is broader than Subpart E, as it covers serious though not terminal diseases, and provides significant benefits over existing treatments. This regulation shows a tendency to make new drugs and therapies accessible for serious diseases other than AIDS. 10 In 1990 Parallel Track or expanded access proposed making some promising drugs accessible (only in the case of AIDS) through clinical research and expanded access. It targeted those individuals who were not eligible for research owing to medical criteria or other reasons, for example, persons living too far from the research centers. The pharmaceutical company donates the drug but does not conduct the clinical trials—a costly procedure, for sure. The physicians write the reports on the harms and benefits. Dideoxyinosine (ddl) and dideoxycytidine (ddC) were distributed under the expanded access system. 11 B. Criticisms: No Distinction between Therapy and Research Are these regulations admissible? Do the changes in FDA regulation solve the critiques activists have made? Is a yet deeper modification in the ethical canons of acceptable research necessary? Some patients have demanded even more radical changes, such as the rejection of the distinction between “research and treatment.” Let us examine the arguments of AIDS activists who pressed for these changes, and analyze how viable they are. The rejection of the distinction between research and therapy questions the need for clinical trials, or the relevance of some scientific practices, such as the use of placebo. In one clinical trial some of the participants refused to take the placebo and withdrew from the trial or surreptitiously exchanged the placebo for the medication, threatening the viability of the research. 12 Some activists urge that the distinction between therapy and research is unnecessary. They identify this distinction as an elitist manifestation of science and patient care, which runs contrary to respect for autonomy. The view claims that respect for research subjects comes by giving them free choice and participation in the research, and not by protecting them from the risks in the research. They demand entitlement to all experiments or unapproved drugs. If no cure has been approved, all options are experimental. All options are equally promising and equally risky. The argument suggests that patients do not differentiate between experimental and non-experimental drugs. What is important to patients is simply whether drugs can or cannot save lives. The problem with this position is that access to experimental drugs with favorable expectations can swiftly lead to access to any kind of drug. The lack of limits proves problematic. This conception leaves future trials without the

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reference of experimental substances. All drugs are on an equal footing. It leaves the definition in the hands of individuals. The definition of research also poses theoretical problems that have a bearing in practice. Wendy Mariner, 13 for example, maintains the difference between therapy and research, arguing that research must be defined in objective and not subjective terms if it is to have a purpose. Independent observers who are impartial to the personal objectives of the researchers and of the research subjects must be able to discern the purpose and content of the research. With the elimination of the distinction between research and therapy, the physician’s obligations become unclear. As a rule, the physician is obligated to use accepted and effective medical practices. But, are physicians accountable for all the harm to their patients if there is no way to identify a shift from the norm? C. Informed Consent as the Only Criterion Another strategy for demanding unrestricted access to experimental drugs allows for the existence of a difference between research and therapy. It reformulates the argument by appealing to the criterion of informed consent, leaving aside the risk-benefit rationale. This view claims that the only limit to experimentation is consent. As long as uncertainty exists, it is up to the research subjects to decide, and society has no right to deny them access to experimental drugs through participation in research. A counterargument holds that consent cannot define the scope of permissible research. It functions as a necessary condition for research, but not as a sufficient condition. If researchers find it unnecessary to evaluate risks and benefits to justify an experiment, then they can justify anything, and participants are left to decide whether they are willing to take the risk. The potential research subject analyzes the risk-benefit. Although this analysis must be part of a deliberation process, personal analysis cannot replace “objective evaluation.” 14 This position allows consent to legitimize any practice. An anti-protection argument could claim that experimentation is the patient’s last hope in some cases, and so would outweigh the risk. If the trial is not beneficial and can even harm the patient, to rank hope above viability or potential risks is deceptive. Persons in situations like these do not always act like competent and rational beings making the best decisions. Out of desperation, they do not aptly weigh information. By exaggerating hope unrealistically, the research subjects cannot give an appropriate informed consent and can easily be considered a vulnerable population in need of protection from exploitation. If hope is well founded, and there is a greater expectation of benefit than of risk, informed consent is not the sole criterion, since the decision is based on an adequate appreciation of the risk-benefit ratio. In this case, the option does appear acceptable. This is a “must” in any research. It is widely accepted that a

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basic condition for any research is its scientific soundness. This means that previous clinical and animal tests have been performed and that an acceptable risk-benefit ratio has been established. If not, it is unethical to conduct the research. Consider the asymmetry of informed consent in the physician-patient relationship and the participant-researcher relationship. In the clinical setting we accept the patient’s competence, which we also accept in the case of clinical trials. In the clinical setting the physician presents genuine options that comply with minimum standards. Physicians cannot suggest unsafe alternative therapies or unsound scientific treatments. Patients, who can choose between possible alternatives, are not in the same situation as research subjects who are at a much greater disadvantage, even if they are just as competent as patients to make a decision. The options that the research subject is offered should have been subjected to a risk-benefit analysis. This is not a case against informed consent as a necessary element in research—it is indisputable that it should be such an element—but against informed consent as the sole criterion. The possible exploitation of vulnerable populations is the danger in considering informed consent as the only condition. D. The “Compassion for Drug Companies” Argument Another objection claims that the new regulations or concessions resulting from AIDS protected the drug companies more than the patients. 15 An analysis of the changes the FDA made shows that Subpart E and expanded access, implemented correctly, benefit the pharmaceutical industry (by saving them time and costs), but also imply an advantage and a benefit for the patients. It not only saves the patients time—which is essential—but makes free drugs accessible to persons who are ineligible for the standard protocol. Likewise, these proposals do not contradict scientific and research canons. The IND policy implies an early sale of the experimental drug and is more objectionable. It presents an additional legal problem. As the drug is experimental, healthcare plans will not cover the costs and the drug will only be accessible to those who can pay. Some researchers have protested that the new changes could work against clinical trials. Why use placebos if a person can buy the drug? However, the criticism does not appear to be all that valid. If clinical trials are ethical and the placebo is properly used, no justification can refute the research (which could lead to better and cost-free attention, etc.). The modifications in the policies on drug approval and research, within limits, undeniably bring huge benefits to the drug companies, but it is also true that these modifications benefit the patients. The criticism is inconclusive, though it helps not to lose sight of the fact that it is the participants’ rights that need protection and not those of the drug companies.

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E. The “Individual Right Versus Protection” Argument Another argument for informed consent as the sole criterion stresses individual freedom. It presents a dilemma: individual right versus protection. Should all protection be abolished and decisions be left in the hands of still vulnerable populations, with all the risks this implies? Harold Edgar and David Rothman pose the problem as a strong dichotomy in the consumer’s right. 16 As a dichotomy—individual right versus protection—Baruch Brody 17 poses the following paradox with respect to drug regulation: any process of drugs regulation calls for a wide balance of objectives that will be more or less correct for some or for others given differences in people’s values. Thus, we cannot develop a drug regulatory process that is ethically correct, because the process would embody the values of some and discriminate against those of others. Brody presents two solutions to the paradox: (1) Reject the drug regulatory process; and, (2) End the rejection and try to establish a rational base for a broad social scheme. Although Brody would say the first option sounds tempting, the proposal is not only too radical to be a viable policy, but raises a concern about the capacity of physicians and patients to assimilate information. Brody thinks that we must reject this first option, since we must also consider the excessive desire of patients or research subjects to take the drugs in question. Brody contemplates the conditions for not approving a drug. If we accept that it is essential to avoid specific risks, then we have to admit the principle of drawing a line somewhere. A second point is to determine where to draw it and what criteria to apply in that process. Brody bases an alternative solution to the paradox on the fact that some preferences for using drugs are irrational and attributes this more to failures in cognition or in the formation of values than to alternative values. He says that these drugs will be rejected when no rational agent, whatever her values, is willing to use the drug. 18 Brody’s position is excessively weak, as the risk-benefit criterion cannot be ignored, and Brody fails to consider it. A point that is often overlooked throughout the discussion is the inadequate assessment of one variable in these demands: the cost-benefit ratio for persons whose lives are seriously threatened and who find the risks negligible (unlike other populations that may find these risks high). Thus, consider at least some variables in the equation: (1) how serious and terminal the disease is; (2) the alternatives for available “adequate” treatments; and, (3) the side effects of the drugs being tested.

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The proposals that incorporate these variables do not necessarily subvert the basic principles in the Codes of Ethics, since the Codes emphasize the importance of risk-benefit analyses. The Codes can still serve as the foundation on which to build new developments. One possibility is that risk-benefit is interpreted more in an Aristotelian way than in a Kantian one: as a search for the golden mean or the middle way, and not as the imposition of an inflexible norm. A correct assessment of the risk-benefit ratio would help maintain ethical standards and would not disregard the traditional role of ethical Codes and Declarations in research. So, the proposals should consider their acceptance by a rational agent (Brody’s suggestion) and an appropriate informed consent by every research subject. F. The “Subjective Evaluation” Argument Nevertheless, some objections can still be raised. The proposals point out that the risk-benefit ratio may have subjective elements. They should be understood in this sense and not with the intention of offering scientific and objective answers. In an excellent article, Loretta Kopelman 19 cites a proposal to conduct an uncontrolled trial in Phase III in Parallel Track and comments on some terms: (1) There should be no other suitable treatment to use as control; (2) There should be enough experience to assure that the patients that do not receive the therapy have an equally poor prognosis; (3) The therapy must not have substantial side effects that can compromise the potential benefits for the patients; (4) There must be justifiable expectations that the potential benefits for the patients will be sufficiently broad so that the results of the nonrandomized trial are not ambiguous; and, (5) The scientific reason for such a treatment must be solid enough for the positive results to be widely accepted. 20 Kopelman explains her stress of some words for their strong evaluative significance: “suitable treatment” for what?; “expectations” for whom?; “acceptable” or “beneficial” in what sense? Answers to these questions demand more than mere scientific judgments. They demand moral and evaluative judgments regarding risks and benefits. The patients’ perceptions of these points often differ from those of the researchers. Researchers are more interested in improving care for future patients, while patients want to know how the treatment will affect them directly. For example, a researcher’s primary interest will be to estimate the differences in the group members’ survival in five years’ time. The patient, on the other hand, may be more interested in quality of life, length of hospitalization, nausea, confusion, or dementia.

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This is a valid point that is implicit in the defense of patients’ rights. However, it does not imply that the answer need fall on informed consent as the sole criterion, nor on total deregulation. Another commendable idea in the Codes is the figure of the community representative, or a respected community leader. The World Health Organization (WHO) and the Council for International Organizations of Medical Sciences (CIOMS) 21 recommend that a representative should help obtain informed consent in rural populations in developing countries that are unfamiliar with modern concepts and techniques in research. In a similar vein, an agent could act on behalf of the patients of a specific disease and, together with the researchers and other organizations, evaluate the risks and benefits of some experimental therapies. In fact, activists and AIDS patients, the patients’ families, or lawyers could represent the patients. The representative could offer the patients’ perspective by explaining their urgent situations, values, and needs. Kopelman proposes a similar idea: the decision not of a patient in particular—given the patient’s extreme and desperate situation that can easily be exploited—but that of a patients’ representative, who would have a role in the planning of the research, and the use of the drugs. The representative could evaluate the risks, benefits, and expectations for the particular population. Research should be considered a cooperative effort, in which research subjects and their advocates recognize approved research methods, and researchers are aware of the patients’ visions and interests. Countering with designs that patients will neither accept nor co-operate with, or proposing poor trial methods that researchers dismiss, threatens the common objective to fight a disease. The main objective of researchers, physicians, and patients must be to overcome the disease. Despite the usual arguments that stress the importance of individual rights and position the debate in exclusive and dilemma-like terms, patients could be dealing with a pseudo-dilemma. Patients do not oppose protection. They oppose inadequate protection. Expressed in these terms, this argument shows hope of a solution and a consensus. G. Different Paradigms or Pseudo-Paradigms? Bioethics has sometimes fallen back on Thomas Kuhn’s notion of science to elaborate different arguments. 22 The notion of different paradigms may well be a useful methodology to explain the above changes. The implementation of new FDA regulations following the criticisms of activists could eventually establish a new paradigm regarding ethics and research. Is this questioning and change in ethics in research with human subjects a paradigmatic shift? Is the era stretching from the post-World War II period to the mid-1980s a protectionist paradigm, and the later period generated by the AIDS crisis a consumer

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paradigm? Undoubtedly, AIDS, AIDS patients, and inoperative regulations triggered a crisis in a rigid model. Kuhn says the development of science is marked by scientific revolutions and shifts in paradigms. 23 However, before responding to the above questions, let us examine some points in the Kuhnian theory. First, a strong concern exists about the adequacy of the position as it is presented in his celebrated book The Structure of Scientific Revolutions. Kuhn speaks of incommensurable paradigms. In a strict sense, this implies alternative paradigms that are incompatible. The Argentine epistemologist, Gregorio Klimovsky says: The incommensurability of paradigms is the Kuhnian thesis according to which the way the paradigm divides, classifies, and articulates reality through the central theory, the system of values, the set of concepts, the kinds of tools used, etc. prevents the “unconverted” from understanding what the “converted” is discussing, and vice versa, for want of a common language. Therefore, the “unconverted” will not be in a position to criticize, accept, or object to what the “converted” maintain. So, each paradigm, metaphorically speaking, becomes a kind of impermeable compartment, with no way out to converse with the person living in the neighboring compartment. 24 The thesis of radical incommensurability poses serious problems of lucidity and coherence, and Kuhn himself eventually abandoned it. Note though that philosophers like Donald Davidson and Samuel Scheffler followed this line of thinking. In the appendix of the same book, Kuhn goes from a language of “incommensurability,” where he speaks of conversions, of scientists living in different worlds, of gestalts, to a language of “partial incommensurability” which allows for translation. 25 The second proposal defends partial or local incommensurability in which only a few concepts change. This is not a conceptually comprehensible proposal. If translation is possible, what criteria help distinguish one paradigm from another? Kuhn says that affirming that two theories are incommensurable means that no language exists, neutral or otherwise, into which both theories, conceived as a set of rules, can be translated without any loss. 26 The first objection is still valid: what criteria distinguish a paradigm? Despite the theoretical difficulties, let us consider the second position and dismiss the first as inconsistent. This theory was designed for science and its development. In a bioethical context it serves as a metaphor to help us understand a change in the conceptualization of how some procedures should be conducted while respecting ethics in research. Granting a correct categorization of paradigm and keeping in mind a much weaker proposal than Kuhn first presents, the shifts in the ethics of experimentation that the AIDS crisis generated cannot be understood as part of or the start of a new paradigm.

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What would constitute a paradigmatic shift in this situation? We could dichotomize and confront the core of one paradigm with the other. That is, we could say that the protectionist paradigm has shifted to the consumer paradigm. Edgar and Rothman advance this idea, in characterizing the two possibilities as tense opposites. The research subject goes from being a person to be protected, to a consumer of research. So, it would appear that a conceptual scheme in which regulations, codes, and principles that focused on respect for persons and their protection, now considers participants in research consumers who are free to make their own choices. These are two quite distinct conceptual schemes in research ethics. However, the supposed second paradigm is not only very extreme, but does not reflect the minimally acceptable conditions for the research subject or the researcher. The patient or research subject cannot function as a client based on mere market rules. It is not a question of two conflicting or two different paradigms. It is a development and refinement of the first proposal: the conceptual scheme remains the same. To see how this conclusion is reached, consider: (1) In both answers (that is, the answers generated by Nuremberg and Helsinki and the second answer generated by the AIDS crisis) the ethical codes still function as a theoretical base. A review of the points of ethical codes shows: x the practice of informed consent; x the right to withdraw from the research upon request; x the idea of an independent research committee and the sponsor or the proposal of representative of the patients; 27 x the need of an analysis of the risk-benefit ratio; and, x the importance of a good scientific design. These recommendations must still be present following the AIDS crisis, even when some regulations are modified or made flexible. (2) The AIDS crisis has made the application of some proposals more complex and subtle (for example, the risk-benefit ratio, the different variables mentioned above, the need to recover the Aristotelian spirit, and so on.) (3) The current vision revises previously established points: criteria in patient selection, the use of placebos, randomized clinical trials, or the beginning and end of the research. This does not imply rejecting these elements outright, but evaluating them based on new needs, and modifying them to maintain a good scientific design.

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What may initially appear to be different is the incorporation of representatives to act on behalf of the patients. This is not a formal regulation. It is an informal proposal, which results from the influence that AIDS activists have had on many of the policy changes. The idea of incorporating the patients’ agents does not contradict the spirit of the ethical codes. To the contrary, it deepens the concept of respect for research subjects. Therefore, it is perhaps more fitting to speak here of “pseudo-paradigms” or partial incommensurability, as they are not incommensurable paradigms, as the first proposal maintains. This is not a shift toward a consumer proposal, or total deregulation proposal. The post-AIDS view is more flexible and contemplates the rights and interests of terminally ill or endangered patients and research subjects. It criticizes inefficient bureaucracies, slow approval times, and rigid criteria or procedures that hamper instead of protecting. This does not mean rejecting the research-therapy distinction, not seeking some scientific criterion, or accepting that the only criterion to define the scope of research is informed consent. It implies heeding the patient and the researcher, as required by Codes, while benefiting the research subjects.

3. AIDS: The New Challenge of Globalization and Research The first part of this chapter examined AIDS and research in light of the questions AIDS activists raised. The debate basically occurred in the United States. It has been explained that those criticisms did not alter the spirit of international ethical codes, but did influence local regulations, mainly in the United States. Since the late 1990s, the debate has become global, and now embraces the interaction between industrialized and poor countries. Following the critiques at the onset of the AIDS pandemic, a new set of problems came to the fore. Commentators and international organizations requestioned the codes in the spirit of modifying them. This time a broader set of international codes and documents were targeted. In 1997 the Declaration of Helsinki began its revision. After a series of drafts in October 2000, the final version of the Declaration of Helsinki, the ethical codes for all research, was also completed. CIOMS and the WHO (2002) revised the International Ethical Guidelines for Biomedical Research Involving Human Subjects. These guidelines focus mainly on the situation of vulnerable populations, among them those in developing countries. Concerns regarding justice begin to be introduced. One of its original objectives, questioned during the revision process, was to complement the Declaration of Helsinki. Finally, UNAIDS, the United Nations Programme on HIV/AIDS, issued a document guiding this particular endeavor: “Ethical Considerations in HIV: Preventive Vaccine Research.” 28 And at the national level, the National Bioethics Advisory Commission of the United States submitted its Report. It examines international research whose objective could have some bearing on the guidelines the United States imposes

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on researchers and sponsoring agencies. The following describes why some of the proposals and views presented to amend ethical codes, unlike those presented at the beginning of the outbreak, are inappropriate. It compares the 2000 version of the Declaration of Helsinki with the drafts that were offered, and shows why these were suitably rejected. A. AIDS in Developing Countries Radical proposals such as the elimination of the distinction between research and therapy, or the sole criterion of informed consent, were not viable. Other objections based on the risk-benefit ratio were valid and helped modify a pseudo-protectionist structure in the trials and approval of drugs. Nevertheless, they did not alter the proposals of ethical codes, but the internal regulations of the agencies that limited access. That is, the changes were based on dignity and respect for persons; they upheld the need to retain the distinction between therapy and research, while maintaining a balance between risk and benefit. They weighed the seriousness of the disease, the lack of alternatives, and the peculiarity of this new disease. The changes questioned the golden rules governing research and drug approval, while keeping in mind the suffering of the individual and the research subject. However, it is unclear how much these factors motivated many of the changes in HIV/AIDS research with subjects in the late 1990s and 2000. Even though serious problems still exist, the situation is currently quite different. Relatively effective treatments exist that have brought hope to sufferers, and improved their life spans and quality of life. At the same time, it should be borne in mind that ninety percent of AIDS patients live in developing countries. In Uganda, for example, the annual expenditure on healthcare totals US$6 per person. 29 AZT treatment in many poor countries is almost impossible to acquire. Treatments are costly and inaccessible to most patients, and preventive methods function inadequately as socio-cultural factors impede their implementation. Therefore, many point out the need to develop effective treatments and a vaccine that can curb the endless expansion of the disease. Research in developing countries is crucial, for the strains of the virus are different. This is extremely relevant to the development of an AIDS vaccine, one of the most critical objectives in recent years. However, carrying out these projects poses another series of challenges: How can ethically acceptable research be conducted in countries that suffer from extreme cases of injustice? What standards must prevail? B. Is the “Simultaneous Condition” dispensable? Research into the AIDS vaccine presents ethical problems that differ in kind and degree, such as informed consent. Consider the problems that can arise in communities at risk that neglect safety measures because they think the tested

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vaccine protects them. Researchers must make sure research subjects clearly understand the existing risks and the use of placebo. Other kinds of problems with respect to risks and benefits concern the limited effectiveness of the first experimental vaccines, as well as the possibility that early research subjects will not have access to the improved vaccine. UNAIDS is aware of these problems. It organized workshops in the host countries developing the clinical trials. The findings of the workshops are interesting and illustrate differences across the developing countries. The groups discussed several points, but two examples suffice: the need to repeat clinical trials in Phase I or II, and the level of therapy for each control group. One issue that arose was that of the current impossibility of conducting the first phases (I and II) of the research with vaccines—that is, the initial clinical trials—on research subjects. The phases involve few participants and test the degree of toxicity, as well as determine how well the drug is tolerated, metabolized, and eliminated. This clause is explicit in the CIOMS Guidelines. The commentary to Guideline 8 says that vaccine studies in Phases I and II should only be conducted in developed communities of the sponsoring country and adds another condition: In general, Phase III vaccine trials and Phase II and III drug trials should be conducted simultaneously in the host community and the sponsoring country; they may be omitted in the sponsoring country on condition only that the drug or vaccine is designed to treat or prevent a disease or other condition that rarely or never occurs in the sponsoring country. 30 The UNAIDS regional groups (in Brazil, Uganda, and Thailand) agreed on the need to repeat the Phase I and II clinical trials in the host country before going on to Phase III. However, the regions disagreed on whether the trials could be conducted in the host countries if they had not been completed in the sponsoring country, and on whether Phase III should be conducted before or together with the sponsoring country. Should the Guideline’s protectionist clause be maintained and prevent the studies in the early phases? Should the clause be eliminated and allow for any kind of research? What sense does the Guideline make? One reason for ending these restrictive conditions is that they assume an unacceptable paternalistic attitude toward developing countries. However, the question of paternalism is inherent throughout the Ethical Codes. Codes of Ethics have a paternalistic spirit and impose restrictions and conditions on the treatment of research subjects. Even the fiercest defenders of autonomy acknowledge the justification of some kind of paternalism. The notion of risks and benefits recognizes this spirit, not to mention the protectionist ends in informed consent. Paradoxically, the problem does not lie in the protection that the Guidelines provide, but in the lack of real protection.

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A careful examination of the proposals reveals some problems: Prohibiting the early stages of research may protect research subjects in the short term by barring their participation in risky studies. But it may lead to even greater danger in the medium and long terms if numerous people are included in Phase III without a prior analysis of the reactions that might occur in the population. This is especially true when the initial phases are conducted in industrialized countries and Phase III is carried out in countries with different socio-economic conditions. The participants may have distinct levels of nutrition and malnutrition. They may be suffering from endemic conditions or diseases. Therefore, it is not irrelevant to test the vaccine in small groups before moving on to a more advanced phase. Under these circumstances, what is supposed to be protection actually jeopardizes the population, and this is a source of concern. Consequently, if the problem lies in the lack of freedom to accept necessary or relevant research, it suffices to eliminate the first clause, the specification that Phase I in drug trials and Phases I and II in vaccine trials cannot be conducted in developing countries. But this was not the proposal. What was suggested instead was the abandonment of the first clause and the simultaneity condition. The simultaneity condition said, “In general, Phase III vaccine trials and Phase II and III drug trials should be conducted simultaneously in the host community and the sponsoring country . . . .” 31 This second clause should apply to all research phases, especially if adding Phases I and II. Note that the simultaneity condition is not inflexible: it allows for exceptions, such as tropical diseases that are not common to sponsoring countries. However, it does act as a safeguard or security mechanism. It assures that clinical trials conducted in developing countries are the same as those conducted in industrialized countries. It implicitly demands the same conditions for all research. It prevents risky investigation without adequate bases from being first tested in developing countries. Eliminating the simultaneity condition, together with the first phases, is problematic. Unfortunately, this issue has not been debated in depth and has been treated as a mere technical problem. C. Standard of Treatment An even more serious issue concerns the kind of treatment research subjects should be able to access. This concerns all kinds of research. The 1989 version of the Declaration of Helsinki 32 defended the “best proven diagnostic and therapeutic method” as the standard of care in research. However, the Summary Report of the UNAIDS Consultation on Ethical Aspects in HIV Vaccine Trials (Draft version, June 1998) states in Point 1.2 that “the best-proven treatment” should be eliminated from the revised version of the Declaration of Helsinki and should be replaced with the idea of the “highest attainable standard.” Commentators such as Robert J. Levine reject the notion of best-proven treatment. Levine defends the “highest attainable and

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sustainable method.” 33 And the April 1999 draft of the Declaration of Helsinki discussed in Chile eliminated “the best-proven treatment.” What does modifying the standard treatment imply? Clinical research groups the participants. Traditionally, one arm tries the new drug, while the second arm receives the best-proven treatment. The new drug is tested for toxicity, effectiveness, and side effects. In light of these procedures, the new proposals recommended the second arm be given the “best attainable therapy.” A first question asks how this term will be applied. Therapy in any country, and in developing countries in particular, differs greatly, and depends on resources. The differences can be significant. Heterogeneity exists not only across countries but within the same countries. What is the “best attainable therapy?” How can it be distinguished from the standard treatment, which in many countries is comparable to no treatment at all, and thus, has been strongly rejected? A second related question asks if such a flexible concept as “best attainable treatment” will not eventually come to be understood as an extremely low and inadequate level of care. This is especially true if we incorporate Levine’s concept of “sustainability” whereby the therapies to be given are the ones that can be continued once the research has concluded. Additionally, the substantive differences between regions of a country should be noted. Some Argentine hospitals in metropolitan areas offer good healthcare, but the situation may be just the reverse twenty kilometers to the north or to the south. So, what is the healthcare paradigm—that of the city, of rural or suburban areas, or of rich or poor provinces? A third question concerns the mechanisms to achieve this. Who is to establish what the adequate level of treatment should be in societies where medical researchers have only recently constituted ad hoc ethical committees in research? Who protects patients in societies without an organized civil society, patient organizations, or representatives of patients? Who is to decide in a society without a long tradition of respect for human rights and adequate control mechanisms? A further issue is related to harms. Researchers are required to minimize harms. Even though harm and unforeseen risks can occur in any research, the absence of approved medical treatment does not fit into the scheme. The final question addresses the acceptability of introducing a double standard. Those fortunate enough to have been born in a wealthy society will receive the best treatment in the research. Those who belong to resource-poor societies “will serve humanity, even at the cost of their health and life” without having received the minimum attention they deserve. UNAIDS regional groups also discussed this issue regarding the AIDS vaccine. Unlike the request to conduct research during the early phases, where there was agreement, this issue generated great dissonance and controversy. Thailand considered that it was acceptable not to offer antiretroviral treatment. The country said that the treatment of research subjects who became

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infected during the research (but not as a result of the research) was to be consistent with that of the rest of the country. There was no healthcare requirement along the lines of the one proposed by the sponsoring country. Uganda indicated some inconvenience and difficulty in establishing the level of treatment, but accepted the possibility of not offering antiretroviral treatment. It claimed that some treatment be offered, but that the sponsoring country should decide on the appropriate kind and level. Such treatment could include immune monitoring, physicians’ visits, prevention and treatment of infections, and palliative treatment, but not necessarily antiretroviral therapy. A country’s highest available standard—through private mechanisms— did not appear to be sustainable because of the costs. One of the agreements maintained that the standard had to be sustainable. 34 Brazil, to the contrary, claimed it was unacceptable and rejected not treating research subjects. It stated that infected participants should be treated like those in the sponsoring country. 35 This was later backed by a resolution of the National Council of Health. 36 UNAIDS reveals significant differences in the way the various developing countries solve this issue. Brazil strongly resisted and prioritized the condition of the research subjects. Thailand and Uganda privileged the researchers and sponsors. Leaving the decision in the hands of individual countries can also prove problematic. Social pressure and lack of resources may force countries to accept disadvantaged positions. These new proposals cannot be taken as mere attempts to evade protectionist policies. Individual countries cannot establish their own convenient standards. This would lead to a decline in the standards of care and treatment and a rejection by those countries that do not accept low standards. Remember that this is international research sponsored by industrialized countries and research that goes beyond national boundaries for the benefit of humankind. It is not a small local trial or research with few resources studying Mal de Chagas (a serious disease that affects some regions in only a few Latin American countries) or Malaria. Introducing variable standards implies legitimizing a double standard: one parameter for rich countries and another for poor countries. Fortunately, the criterion of “the highest attainable and sustainable therapy” has been rejected, as well as an explicit double standard. D. Other Views What gave rise to these changes? Persuasive views argue for the modification of the high standard of offering the best-proven therapy. One of the strongest presents an utilitarian justification, and indicates how it can benefit poor countries. The view can be outlined as follows. Successful research will bring progress and benefits to resource-poor countries. Instead, obstacles to research can cause long-term harm. Demanding the best-proven therapy, which is frequently costly, can diminish research. Inexpensive research can ultimately save more

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lives. In this scenario, some participants will die (the ones in the control group); others will become ill. However, in the long term many will be saved as treatments and beneficial drugs will be available to the community. One objection to this view points to the lack of certainty and the fallibility of human deliberation, reinforced, in this case, by the question of research. However, it is not a strong argument: it disqualifies all research. A second objection points out the weak side of the utilitarian argument: that it presupposes relatively immediate access to the approved drug or therapy. The point is indeed a basic assumption in the argument—however, it is also an element that ethics in research has considered. For example, researchers, sponsors, governments