oxford handbook of bioethics

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viewpoints, sharpening and deepening the debate on a number of controversial issues.

ASHORT HISTORY OF BIOETHICS

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Bioethics was preceded by medical ethics, which focused primarily on issues arising out of the physician – patient relationship. The ancient Hippocratic literature (which includes but is not limited to the Hippocratic Oath) enjoins doctors to use their knowledge and powers to benefit the sick, to heal and not to harm, to preserve life, and to keep in the strictest confidence information that ought not to be spread about (though precisely what must be kept confidential is not detailed). These basic values and principles remain an essential part of contemporary bioethics. However, after the Second World War it became clear that the old medical ethics was not sufficient to meet contemporary challenges.

Unprecedented advances in medicine, including the use of penicillin and immunizations against childhood diseases, have saved literally millions of lives. So have open heart surgery and cardiac catheterization, chronic hemodialysis, and organ donation. At the same time, many of the tools of modern medicine are very expensive, and thus out of the reach of many who might benefit from them. Medicine’s success thus led to a debate about how to pay for health care. In most industrialized countries, the provision of health care is viewed as the responsibility of government, comparable to the obligation to provide public education. By contrast, in the United States many still regard payment for health care as an individual responsibility, or at least something that employers, not the state, should provide. Among those who agree that some kind of national health insurance is both fair and fiscally sound, a debate continues between egalitarians, who insist that no care should be provided unless it is available to all who need it, and those who favor a tiered health care system that allows some medical services to be distributed by the market. (This issue is thoroughly explored in Part II, Chapter 7, by Benjamin J. Krohmal and Ezekiel J. Emanuel.)

Medicine’s successes in the post-war years raised another issue: the value of preserving life. Respirators were originally invented for people who were expected to recover and be able to breathe on their own. Within a short period of time they began to be used on people in persistent vegetative states, forcing medical professionals to ask whether this was an appropriate use of technology. Should people who are permanently and irreversibly unconscious be kept alive indefinitely? A similar issue resulted from the development of neonatal intensive care units (NICUs), which have saved the lives of many premature babies who would have died in earlier decades. Many of these babies go on to have normal, healthy lives, but many face a lifetime of severe disabilities and serious health complications.

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Thus, NICUs raise the question: Ought life to be preserved regardless of the nature or quality of that life? And if there are times when life should not be preserved, who should be authorized to make these decisions?

During the 1960s these questions began to be debated at academic conferences and in scholarly journals, giving birth to the field of bioethics. In 1969 the Hastings Center in Garrison, NY, an independent, nonpartisan, and nonprofit bioethics research institute, was founded by Dan Callahan and Willard Gaylin to explore fundamental and emerging questions in health care, biotechnology, and the environment. Its journal, the Hastings Center Report, first appeared in June 1971. In July of that year the Kennedy Institute of Ethics at Georgetown University opened, with two research scholars: LeRoy Walters, who soon became its Director, and Warren Reich, who was the editor of the first edition of the Encyclopedia of Bioethics, published in 1978.

The term ‘bioethics’ was coined in the early 1970s by biologists who brought to the public’s attention two pressing issues: the need to maintain the planet’s ecology, on which all life depends, and the implications of advances in the life sciences toward manipulating human nature. In his book, Bioethics: Bridge to the Future, published in 1971, Van Rensselaer Potter focused on the growing human ability to change nature, including human nature, and the implications of this for our global future. This issue has been revisited in recent years in a growing literature on enhancement, genetic and otherwise, and is addressed from very different perspectives in Part VI Chapters 21 and 22, by Thomas Murray and Julian Savulescu respectively. Although the term ‘bioethics’ has referred almost exclusively to problems in biomedicine, in recent years the field has returned to ‘the wider context provided by the life scientists of the early 1970s, including their environmental and public health concerns’ (Post 2004, p. xi). (The relevance of public health for bioethics is covered in Part VIII, Chapter 28, by Jeffrey Kahn and Anna Mastroianni.)

While bioethics has been interdisciplinary since its inception, theology played a foundational role in its creation. It continues to have a profound influence today, as reflected in the careful analysis and defense of the rule of double effect by Daniel Sulmasy in Part I, Chapter 5. Three theologians in particular were instrumental in the birth of bioethics: Joseph Fletcher, an Episcopal minister; Paul Ramsey, a Methodist minister; and Richard McCormick, a Jesuit moral theologian. The theologians were soon joined by philosophers who rejected the emphasis in contemporary analytic ethics on meta-ethics, to the exclusion of normative ethics. Events in the 1960s — opposition to the war in Vietnam, the civil rights movement, and other social movements it spawned, such as the women’s movement, the disability rights movement, and the gay and lesbian rights movement — played a role in the revitalization of normative ethics, and philosophical interest in applied ethics. Students began to demand that their courses were ‘relevant’, and professional philosophers also became interested in writing on the issues of the day. Philosophers now specialize in bioethics, but even philosophers not usually thought

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of as ‘bioethicists’, including Jonathan Bennett, Ronald Dworkin, Joel Feinberg, Jonathan Glover, Thomas Nagel, Onora O’Neill, Judith Thomson, and Bernard Williams, have made important contributions to the bioethics literature.

A new journal, Philosophy and Public Affairs, appeared in 1971, with lead articles on war and abortion. John Rawls’s A Theory of Justice appeared the same year. The book had a huge impact on Anglo-American political philosophy, and indirectly on bioethics. As Jonsen (1998: 74) puts it, ‘Rawls’s thesis excited many moral philosophers, restored faith in a rational approach to ethics, provided a carefully articulated version of contractarianism, and bequeathed to some future bioethicists the basis for a theory of the allocation of medical resources.’ The influence of Rawls can be seen in many of the chapters in this volume, especially in Parts I and II.

CENT RAL ISSUES IN BIOETHICS

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At its inception, the central issues in bioethics were research with human subjects, genetics, organ transplantation, death and dying, and reproduction. As a glance at the table of contents reveals, these continue to be important issues today.

Methodology has been a central theoretical issue since the very beginning of bioethics. While some hoped that bioethics would generate a single correct normative theory, that idea has been given up by most practitioners. Indeed, bioethics reflects a wide range of theoretical approaches in normative ethics, including utilitarianism, deontology, natural law, contractarianism, virtue ethics, communitarianism, pragmatism, and feminist ethics (Steinbock et al. 2003). All of these approaches, and variations within these, are carefully enunciated by James Childress in Part I, Chapter 1. As Childress perhaps ruefully concludes, ‘It is probably too much to expect consensus about the best possible method(s), all things considered — at most, we can take advantage of the strengths of each method and compensate for its special deficiencies.’

A related issue concerns the relationship between abstract principles and concrete particulars. An approach that has come to be known as ‘principlism’, famously advocated by Beauchamp and Childress in their classic text Principles of Bioethics (1979 – 2001), attempts to derive answers to bioethical dilemmas from the basic principles: autonomy, beneficence, and justice. Principlism has been criticized, as John Arras points out in Chapter 2, by casuists, feminists, partisans of narrative ethics, and pragmatists as ‘too abstract, deductive, and ‘‘top down’’ ’; as being ‘insufficiently attentive to particulars, relationships, storytelling, and process’. In response, principlists have attempted to incorporate these insights into a principlebased approach, using Rawls’s method of ‘reflective equilibrium’. However, while this approach has considerable intuitive appeal, it is far from clear exactly how reflective equilibrium is to be interpreted or applied. Arras provides a clear and

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thorough analysis of the difficulties, ending on a moderately skeptical note about the value of method in moral inquiry. No method, he says, is a guarantor of truth, or even intersubjective agreement, but careful attention to the various approaches can improve practical reasoning and ‘facilitate our quest for moral justification’.

In addition to methodological issues, theoretical issues in bioethics include certain concepts and principles. Of these, perhaps the most central is autonomy. The prominence of autonomy in biomedical ethics can be traced back to the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979), so called because it had its origins in a meeting held in February 1976 at Belmont House, a conference center of the Smithsonian Institution. Congress had instructed the Commission to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects. The Commission articulated three basic principles: respect for persons, beneficence, and justice. The articulation of these principles had a major impact on the development of bioethics, and indeed on virtually every chapter in this volume. These concepts found their way into the general literature of the field, and evolved from the principles underlying the conduct of research into the basic principles of bioethics. ‘Respect for persons’ became understood as ‘respect for autonomy’ or simply ‘autonomy’. Yet while autonomy is unquestionably a central principle in bioethics, both its interpretation and its moral weight remain controversial, as Bruce Jennings illustrates in Chapter 3.

The issue of autonomy is considered from the perspective of moral psychology in Chapter 4, by Jeanette Kennett. While mental illness clearly can rob a person of the capacity for autonomous choice and action, it is also true that this has been exaggerated in the past by prejudice and stigmatization. What, then, is the correct attitude to take toward those suffering from mental illness? Kennett reminds us that ‘agency comes in degrees, that autonomy is an achievement, and that respect for autonomy may require our active support for the agency of those in adverse circumstances’, including mental illness. Acknowledging the difficulty of adopting ‘the participant stance’ toward those who are seriously mentally ill, Kennett argues that nevertheless we are morally required to adopt it, so far as possible.

Part II turns to issues of justice and policy. Like Arras in the preceding section, Søren Holm, a Danish philosopher and physician, starts with Rawls, although Holm is less interested in reflective equilibrium as a methodology, and more interested in the requirements of deliberative democracy. He notes that while policy making shares some of the values of ethical decision making (such as reasonableness, reciprocity, consistency, and integrity), it also incorporates features that may be anathema to philosophers, including political compromise, moratoria (waiting periods while scientific uncertainty is resolved), and the accommodation of minority positions. These political tools, Holm argues, are as important as philosophical reasoning for achieving ‘peaceful public decision making in a context of fundamental moral disagreement’.

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The next chapter, by Benjamin J. Krohmal and Ezekiel J. Emanuel, considers whether a just health care system must be strictly egalitarian (as in Canada and Norway), or whether a better approach allows for a tiered health care system, in which some people can pay for greater access to services than others with the same needs. After examining the arguments pro and con, the authors conclude that an egalitarian approach is unjust. Justice calls for a two-tier health care system with universal public coverage (as in Britain and Israel).

Another question of distributive justice arises because people have different needs for health care. For example, as people age, they are likely to need more and more expensive health care, including prescriptions, tests, and hospital stays. In Chapter 8 Dennis McKerlie, a Canadian philosopher, addresses this issue, asking, ‘Are the elderly receiving less, or more, than their fair share of health resources and economic wealth?’ An important part of the answer depends on how principles of justice are applied. McKerlie contrasts a ‘complete lives’ view, which focuses on people’s lifetime expectations of receiving primary goods, with the prudential lifespan account, proposed by Norman Daniels and Ronald Dworkin, in which principles of justice have a temporal scope. He rejects both in favor of what he calls the ‘life-stage view’, which is more generous to the elderly than either the complete lives view or the prudential lifespan account, in large measure because they need help the most. The chapter ends with a thoughtful reflection on the effects of aging on individuals’ abilities and values, and the implications this has both for respect for autonomy and for a just distribution of resources.

Part III addresses a set of issues turning around human bodies and parts of bodies. In Chapter 9 Ronald Munson outlines the history, economics, and ethics of organ transplantation, an issue that has been prominent in medical ethics since the first organ transplant in 1954. Most transplants are taken from dead donors, but many more lives could be saved if the number of living donors of kidneys and livers was increased. The risks to donors, however, are considerable, and the chance of coercion or undue influence is thought by some to undermine voluntariness and autonomy. However, Munson argues that paternalistically denying someone the opportunity to be a living donor is a greater threat to autonomy, especially since measures can be taken to protect voluntariness.

The next chapter, by Louise Irving and John Harris, on biobanking discusses the methods and purposes of tissue storage and collection. A major theme is the great importance of tissue collection to medical research, which at the same time raises issues of confidentiality, consent, stigmatization, and risk. While these need to be taken seriously, Irving and Harris argue that the ethical problems raised by biobanking are neither unique nor unresolvable.

Carolyn McLeod, in Chapter 11, addresses the issues of oocyte vending and commercial contract pregnancy from a feminist perspective. The commodification of women’s reproductive capacity presents feminists with a classic double bind. Should a market in reproductive labor be viewed as degrading and rife with the

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potential for harm and exploitation of women? Or should the ability to sell one’s labor (reproductive or otherwise) be viewed as empowering, and the denial of this right inconsistent with women’s status as autonomous persons? McLeod does not resolve this issue, but suggests several ways in which the debate could be refined and clarified.

Part IV opens with an update on the problems with the definition and determination of death. Stuart J. Youngner illustrates the ways in which this is not only a scientific issue, but a matter of philosophy and policy as well. His chapter dovetails nicely with Munson’s, on organ transplantation, since the possibility of transplanting organs from deceased donors has influenced, if not driven, the conceptual debates about death.

One of the challenges of the twenty-first century is the increase in lifespan, and the consequent increase in numbers of the very old, issues addressed by Stephen Post and Felicia Nimue Ackerman in Chapters 13 and 14. While both Post and Ackerman disagree with the natural law approach taken by, for example, Leon Kass, they disagree with each other about the value of extending life when this entails illness and deterioration.

John K. Davis returns, in Chapter 15, to the issue of autonomy in his discussion of advance directives (ADs). A number of writers have argued that ADs pose an insoluble problem. They express the values and preferences of the competent individuals who write them, but they go into effect only when the individuals are no longer competent. Once incompetent, they are likely to have very different interests than the interests they had when competent. They may no longer care about, or even be cognizant of, issues such as dignity and independence. Indeed, some would argue that the presently incompetent individual is so radically changed that he or she is not the same person as the individual who wrote the AD, and that therefore the writer of the AD does not have the moral authority to decide that lifesaving treatment should be withheld from the present incompetent person. Drawing a distinction between loss of capacity and loss of concern, Davis defends ADs against this particular criticism. Gerald Dworkin ends this part with a careful analysis of the arguments for and against physicianassisted death, and a defense of physician-assisted suicide, though not, for strategic reasons, euthanasia.

Part V concerns issues at the beginning of life, specifically the morality of abortion and embryonic stem cell research. In 1989 Don Marquis published a now classic article, ‘Why Abortion Is Immoral’, in which he argued that both pro-life and pro-choice approaches were seriously flawed. In their place, he offered a new approach, the future of value argument. It maintains that the best explanation for the wrongness of killing is that killing deprives us of our valuable futures. Because we were once fetuses, fetuses have the same futures of value that every one of us has, and therefore abortion is ‘seriously presumptively wrong’. In this new chapter Marquis elaborates on the notion of having a future of value, and argues that this

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argument is superior to recent accounts of moral status provided by Mary Anne Warren and David Boonin.

My own contribution to the book concerns the moral status of extracorporeal embryos, and the implications this has for embryonic stem cell research (ESCR). The chapter builds on the interest view, which I elaborated in Life Before Birth (1992). I argue that very early embryos (blastocysts) have no moral status, because they lack interests of their own. This means that we cannot act in their interest or on their behalf; they cannot be harmed or benefited. Nevertheless, as developing forms of human life, they have moral value, and are entitled to respect. I distinguish between the respect owed to human embryos and Kantian respect for persons, and argue that the respect owed to embryos does not rule out using them merely as means to our ends. Instead, it requires that the ends served be morally important ones. Potentially valuable scientific research qualifies as morally important, and is therefore consistent with respect for human life.

In the last chapter in Part V Andrea Bonnicksen returns to an issue addressed in Part I by Søren Holm: policy making in pluralistic societies. In the United States ESCR is politically extremely divisive. There is no federal support for it, and hence no federal oversight. Yet several states (California, New Jersey, Massachusetts, Illinois) have passed legislation to allow and/or fund ESCR, including the cloning of human embryos. Moreover, several private laboratories are attempting to clone human embryos and derive stem cell lines, without, however, the kind of oversight and ethical reflection characteristic of the Human Fertilization and Embryology Authority in the United Kingdom. Bonnicksen suggests that a ‘policy community’, consisting of academics, policy analysts, interest group members, and others with shared interests, might be able to overcome the current stalemate, both within the United States and internationally, and address some of the pressing ethical concerns raised by therapeutic cloning.

In addition to the issue of enhancement previously mentioned, Part VI addresses issues in genomic medicine. In Chapter 20 Eric Juengst notes that while the interest in mapping the human genome was initially genealogical, interest soon developed in the possibility of tailoring diagnostic protocols, therapeutic interventions, and preventive measures to each patient’s genetic profile. This would have profound implications not only for medicine, but also for public health (this is addressed in Part VIII, Chapter 28, by Jeffrey Kahn and Anna Mastroianni). At the same time, it has raised old questions about racism and discrimination, as well as new questions about the collective interests of groups being studied. In Chapter 23 Matthew DeCamp and Allen Buchanan focus specifically on the role pharmaceuticals play in genomic medicine. In addition to problems resulting from the reifying of race, pharmacogenomic technologies raise serious issues of distributive justice: who will get these new drugs, on what basis will decisions to produce them be made, and who will pay for them?

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Part VII concerns the ethics of research on human subjects, a subject that has been at the heart of bioethics since its inception. For most of its history, medicine was primarily therapeutic. Experimentation was limited to trying new curative or palliative approaches on individual patients. As medicine became more of a science, physicians wanted to know if their treatments, standard and innovative, actually worked. To do this, one needed to perform experiments on people, not primarily to benefit them, but to learn things that might benefit others. This put physician – researchers into a double bind. In so far as they were acting as the patient’s doctor, their aim was to benefit the patient. In so far as they were acting as scientific researchers, their aim was to perform a controlled experiment and get accurate results. Typically, this means assigning subjects randomly to the various arms of a clinical trial without regard to whether the standard treatment, the new treatment, or placebo would be in the patient – subject’s best interest. It seems that physicians cannot satisfy both roles simultaneously.

As Alex London points out in the first chapter in Part VII, Charles Fried attempted to solve this dilemma through the notion of ‘equipoise’. Physicians were justified in enrolling their patients in clinical trials only if they were uncertain about the relative therapeutic merits of various arms of the trial. However, as London notes, there is considerable uncertainty about how precisely to formulate the requirement of equipoise. After clarifying different versions of the equipoise requirement, and demonstrating their respective strengths and weaknesses, London proposes a novel approach to research ethics that better avoids the exploitation of research participants.

The problem of exploitation is central to the next three chapters as well. In Chapter 25 the physician Jason Karlawish examines the problem of research on individuals who, due to cognitive impairment, cannot give informed consent. Is it possible both to accomplish valuable research and also to protect vulnerable individuals? This issue is also addressed by Florencia Luna (and again in Part VIII in the chapter by Jeffrey Kahn and Anna Mastroianni) from the perspective of research on vulnerable populations, namely, individuals in developing countries. The problems of such research were brought into sharp relief in the late 1990s, when clinical trials were done in sub-Saharan Africa, Asia, and Latin America to find a more economical and effective treatment for preventing mother-to-baby transmission of HIV/AIDS. A proven treatment for preventing transmission existed, and was standard in the United States and other developed countries. However, it was not only expensive (far beyond the health care budgets of developing countries), but also burdensome to administer — perhaps even impossible in the conditions in most developing countries. To see if a less expensive, less burdensome regimen was effective, half the subjects in the trial were given the proposed regimen and half were given placebos. This was extremely controversial because normally a new treatment is tested against the proven treatment to determine if it is as effective.

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This was not done in the so-called ‘AIDS-African trials’ because the proven regimen was beyond the economic reach of developing countries. The issue for them was not whether the new regimen was as effective as the proven regimen, but whether it was better than nothing (i.e. placebo). If it was not, there would be no point in using scarce health care dollars to provide it to HIV-infected pregnant women. This seemed reasonable, and yet such a protocol would never be approved in a developed country. Critics complained of introducing a double standard into international research — ‘a standard for industrialized countries that can provide the best existing therapies and another for poor countries with limited funding and a deficient healthcare system’. Exploitation of vulnerable populations is a real problem, but not one that can be solved with slogans, Luna argues. Obligations to research subjects during and after clinical trials must be considered, as well as the benefit to of individuals and communities who participate in research.

Part VII ends with a discussion of research on animals. Ever since Peter Singer’s Animal Liberation appeared in 1975, there has been a lively debate about the moral status and treatment of animals. Although the treatment of human beings in research has at times been scandalous (with the experiments on Jews and others in Nazi concentration camps being the most heinous example), such treatment of non-human animals is pervasive. Animals are routinely killed, maimed, shocked, burned, and caused terrible pain, in the name of scientific and medical progress. In Chapter 27 Alastair Norcross examines various justifications for inflicting pain on non-human animals, and concludes that they are unsuccessful, and that this renders much animal experimentation morally unacceptable.

Part VIII explores some relatively new directions for bioethics: the turn to public and global health. On the one hand, public health seems at odds with bioethics because the focus in public health is the health of the population or community, whereas the focus in medicine is the health of the individual. Moreover, even as bioethics diverged from traditional medical ethics, it retained the principle of respect for individual autonomy, and correlative principles of confidentiality and privacy. On the other hand, there has been a kind of self-correction in the field of bioethics, away from an excessive individualism and toward engagement in questions of public health and global justice. In the first chapter in Part VIII Jeffrey Kahn and Anna Mastroianni discuss these issues, using as examples HIV/AIDS, resource allocation, and public health genomics.

In the next chapter Ruth Macklin explores the notion of ‘globalization’, and explains why in today’s globalized world public health is global health. In part, this is because intercontinental travel makes the spread of disease so rapid, increasing the possibility of global pandemics. In addition, actions and policies carried out in one part of the world are likely to have significant, and often harmful, effects on people very far away. Thus, it becomes increasingly impossible to reject responsibility for those effects. Finally, the world’s problems can only be solved by international cooperation.

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In the last chapter Jonathan Moreno discusses the ethical problems raised by bioterrorism, including the tension between respecting civil liberties and protecting the public’s health, triage in a bioterror attack, and the responsibilities of emergency health care professionals. Moreno’s chapter is an excellent example of the way in which bioethics can draw on historical parallels even as it adapts in response to new developments and challenges. As science and medicine continue to advance, new issues are constantly being raised, for example, in neuroscience, bioengineering, and nanotechnology. Some of these emerging sciences and technologies may pose genuinely new questions for bioethics; others can be characterized as ‘old wine in new bottles’. Controversy over this question (and others) is inevitable, as bioethicists identify and analyze new issues, thus framing the debates of the twenty-first century.

REFERENCES

BEAUCHAMP, T., and CHILDRESS, J. (1979 – 2001), Principles of Bioethics, (1st – 5th edns. New York: Oxford University Press).

JONSEN, A. R. (1998), The Birth of Bioethics (New York: Oxford University Press). MARQUIS, D. (1989), ‘Why Abortion Is Immoral’, Journal of Philosophy, 89: 183 – 202.

MURRAY, T. A., and MEHLMAN, M. (eds.) (2000), The Encyclopedia of Ethical, Legal and Policy Issues in Biotechnology (New York: John Wiley).

NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL AND

BEHAVIORAL RESEARCH (1979), The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Washington, DC: Government Printing Office).

POST, S. G. (ed.) (2004), The Encyclopedia of Bioethics, (3rd edn. New York: Macmillan). POTTER, V. R. (1971), Bioethics: Bridge to the Future (Englewood Cliffs, NJ: Prentice-Hall). SINGER, P. (1975), Animal Liberation (New York: Random House).

STEINBOCK, B. (1992), Life Before Birth: The Moral and Legal Status of Embryos and Fetuses

(New York: Oxford University Press).

ARRAS, J. D., and LONDON, A. J. (2003), Ethical Issues in Modern Medicine, (6th edn. Boston: McGraw-Hill).