What is good, how do we know, and how important is it? In this book, one of our most respected analytical philosophers reorients these questions around the notion of what causes human beings to flourish. Observing that we can sensibly address what is good for plants and animals no less than what is good for people, Kraut applies a general principle to the entire living world: what is good for complex organisms consists in the exercise of their natural powers.

Beyond Consent examines the concept of justice, and its application to human subject research, through the different lenses of various research populations: children, the vulnerable sick, captive and convenient populations, women, people of colour, and subjects in international settings. Separate chapters address the evolution of research policies, implications of the concept of justice for the future of human subject research, and the ramifications of this concept throughout the research enterprise.

Shared views regarding the moral respect which is owed to children in family life are used as a guide in determining the moral permissibility of nontherapeutic clinical research procedures involving children. The comparison suggests that it is not appropriate to seek assent from the preadolescent child. The analogy with interventions used in family life is similarly employed to specify the permissible limit of risk to which children may be exposed in nontherapeutic research procedures. The analysis indicates that recent writers misconceive (...) how certain moral principles, such as respect for personal autonomy, require us to act toward children. The results are also used to assess proposed federal regulations on research with children. (shrink)

This book is the most comprehensive treatment available of one of the most urgent - and yet in some respects most neglected - problems in bioethics: decision-making for incompetents. Part I develops a general theory for making treatment and care decisions for patients who are not competent to decide for themselves. It provides an in-depth analysis of competence, articulates and defends a coherent set of principles to specify suitable surrogate decisionmakers and to guide their choices, examines the value of advance (...) directives, and investigates the role that considerations of cost ought to play in decisions concerning incompetents. Part II applies this theoretical framework to the distinctive problems of three important classes of individuals, many of whom are incompetent: minors, the elderly and psychiatric patients. The authors' approach combines a probing analysis of fundamental issues in ethical theory with a sensitive awareness of the concrete realities of health care institutions and the highly personal and individual character of difficult practical problems. Its broad scope will appeal to health professionals, moral philosophers and lawyers alike. (shrink)

Considers that intuitive predictions follow a judgmental heuristic-representativeness. By this heuristic, people predict the outcome that appears most representative of the evidence. Consequently, intuitive predictions are insensitive to the reliability of the evidence or to the prior probability of the outcome, in violation of the logic of statistical prediction. The hypothesis that people predict by representativeness was supported in a series of studies with both naive and sophisticated university students. The ranking of outcomes by likelihood coincided with the ranking by (...) representativeness, and Ss erroneously predicted rare events and extreme values if these happened to be representative. The experience of unjustified confidence in predictions and the prevalence of fallacious intuitions concerning statistical regression are traced to the representativeness heuristic. (shrink)

How should medical services be distributed within society? Who should pay for them? Is it right that large amounts should be spent on sophisticated technology and expensive operations, or would the resources be better employed in, for instance, less costly preventive measures? These and others are the questions addreses in this book. Norman Daniels examines some of the dilemmas thrown up by conflicting demands for medical attention, and goes on to advance a theory of justice in the distribution of health (...) care. The central argument is that health care, both preventive and acute, has a crucial effect on equality of opportunity, and that a principle guaranteeing equality of opportunity must underly the distribution of health-care services. Access to care, preventive measures, treatment of the elderly, and the obligations of doctors and medical administrations are fully discussed, and the theory is shown to underwrite various practical policies in the area. (shrink)

In this major book Martha Nussbaum, one of the most innovative and influential philosophical voices of our time, proposes a kind of feminism that is genuinely international, argues for an ethical underpinning to all thought about development planning and public policy, and dramatically moves beyond the abstractions of economists and philosophers to embed thought about justice in the concrete reality of the struggles of poor women. Nussbaum argues that international political and economic thought must be sensitive to gender difference as (...) a problem of justice, and that feminist thought must begin to focus on the problems of women in the third world. Taking as her point of departure the predicament of poor women in India, she shows how philosophy should undergird basic constitutional principles that should be respected and implemented by all governments, and used as a comparative measure of quality of life across nations. (shrink)

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.United States research regulations are derived largely from the deliberations and report of the National Commission for the Protection of Human Subjects of Biomedical (...) and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses. (shrink)

It will be seen how in place of the wealth and poverty of political economy come the rich human being and rich human need. The rich human being is simultaneously the human being in need of totality of human life-activities — the man in whom his own realization exists as an inner necessity, as need. Marx, Economic and Philosophical Manuscripts of 1844 Svetaketu abstained from food for fifteen days. Then he came to his father and said, `What shall I say?' (...) The father said: `Repeat the Rik, Yagus, and Saman verses.' He replied, `They do not occur to me, Sir.' The father said to him... `Go and eat! Then wilt thou understand me.' Then Svetaketu ate, and afterwards approached his father. And whatever his father asked him, he knew it all by heart.... After that, he understood what his father meant when he said: `Mind, my son, comes from food, breath from water, speech from fire.' He understood what he said, yea, he understood it. Chandogya-Upanishad, VI Prapathaka, 7 Kanda When you love a man you want him to live and when you hate him you want him to die. If, having wanted him to live, you then want him to die, this is a misguided judgment. `If you did not do so for the sake of riches, you must have done so for the sake of novelty.' Confucius, Analects, Book 12. 10. (shrink)

In the specialized area of pediatric endocrinology, the use of human growth hormone (hGH) both for children who have a growth hormone abnormality and for the treatment of non-hGH-deficient children who are short is a current clinical reality that raises important ethical questions. Generally speaking, the use of hGH for those children who are clearly lacking it is an efficacious intervention based upon established clinical criteria. The use of hGH for children who are short, but have no growth hormone abnormality (...) is ethically and clinically more controversial. The moral conundrum of how to gain knowledge about new medical treatments that may be beneficial to children while, at the same time, ethically enrolling them in clinical trials with placebo arms in order to gain such knowledge will continue to be a contentious issue in the conduct of research and in the delivery of health care. In addition, there are questions about what ought to be studied and whether a physical characteristic such as short stature ought to be viewed as a circumstance of less than optimal health. (shrink)

The Kennedy Krieger lead paint study received a lot of attention after a US Court of Appeals ruled that a parent cannot consent to the participation of a child in non-therapeutic research. The ruling has raised fears that, if it goes unchallenged, valuable research might not proceed and ultimately all children would be harmed. The author discusses significant aspects of the study that have been neglected, and argues that the study was unethical because it involved injustice and its design meant (...) that the study lacked importance and value. Issues of benefit, risk, and consent are vital, but it is sometimes a mistake to consider these issues before settling questions about justice and the importance and value of a research project. The author concludes by offering a strategy for researchers and reviewers of research to appreciate, in a vivid way, the implications of research participation. (shrink)

This book examines the ethical issues in pediatric medical research. It argues that policies and practices on the participation of children must focus primarily on minimizing risks. It offers specific recommendations to revise Subpart D of the federal regulations to provide greater protection where necessary and remove obstacles that do not provide additional protection but interfere with access. The book is divided into four sections. Section 1 focuses on the issue of access versus protection in pediatric research. Section 2 deals (...) with challenges to regulations. Section 3 discusses the strengths and limits of current regulations, while different case studies are examined in Section 4. (shrink)

There are roughly two philosophical literatures on “happiness,” each corresponding to a different sense of the term. One uses ‘happiness’ as a value term, roughly synonymous with well-being or flourishing. The other body of work uses the word as a purely descriptive psychological term, akin to ‘depression’ or ‘tranquility’. An important project in the philosophy of happiness is simply getting clear on what various writers are talking about: what are the important meanings of the term and how do they connect? (...) While the “well-being” sense of happiness receives significant attention in the contemporary literature on well-being, the psychological notion is undergoing a revival as a major focus of philosophical inquiry, following on recent developments in the science of happiness. This entry focuses on the psychological sense of happiness (for the well-being notion, see the entry on well-being). The main accounts of happiness in this sense are hedonism, the life satisfaction theory, and the emotional state theory. Leaving verbal questions behind, we find that happiness in the psychological sense has always been an important concern of philosophers. Yet the significance of happiness for a good life has been hotly disputed in recent decades. Further questions of contemporary interest concern the relation between the philosophy and science of happiness, as well as the role of happiness in social and political decision-making. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 22-23, June 2011.

The concept of minimal risk has been used to regulate and limit participation by adolescents in clinical trials. It can be understood as setting an absolute standard of what risks are considered minimal or it can be interpreted as relative to the actual risks faced by members of the host community for the trial. While commentators have almost universally opposed a relative interpretation of the environmental risks faced by potential adolescent trial participants, we argue that the ethical concerns against the (...) relative standard may not be as convincing as these commentators believe. Our aim is to present the case for a relative standard of environmental risk in order to open a debate on this subject. We conclude by discussing how a relative standard of environmental risk could be defended in the specific case of an HIV vaccine trial among adolescents in South Africa. (shrink)

Many philosophers believe that Robert Nozick's experience machine argument poses an insurmountable obstacle to hedonism as a theory of well-being. After an initial attempt to demonstrate that the persuasiveness of this argument rests on a key ambiguity, I argue that the intuitions to which the thought experiment appeals are not nearly as clear as many philosophers suppose they are. I believe that a careful consideration of the origin of those intuitions -- especially in light of the so-called "paradox of hedonism" (...) -- reveals that they can, in fact, fit quite comfortably into a hedonistic theory of well-being. (shrink)

The prescription of growth hormone therapy for children who are not growth hormone deficient is one of the controversies in contemporary paediatric endocrinology. Is it morally appropriate to enhance the growth, by means of medical treatment, of a child wish idiopathic short stature? The medical, moral, and philosophical questions in this area are many. Data on the effects of human growth hormone (hGH) treatment will not on their own provide us with answers, as these effects have to be evaluated from (...) a normative perspective. In this article we consider hGH treatment for children of idiopathic short stature from three normative perspectives: the goals of medicine, the good of the patient, and the public good. We argue that the prevention of psychological and social problems due to short stature (and not merely the enhancement of growth) should be the ultimate goal of medical treatment and research. (shrink)

The phrase “minimal risk,” as defined in the United States’ federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the “daily life risks” standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that “minimal risk” should be defined as simply “the probability and magnitude of the harm or discomfort anticipated in research (...) are not greater than those encountered during the performance of routine physical or psychological examinations or tests”. (shrink)

The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of risk (...) in research is required. Component analysis provides such a systematic approach. (shrink)

Research involving the vulnerable sick raises difficult challenges for investigators and Institutional Review Boards. Exactly who among the ill counts as vulnerable is a matter of judgement, and involves consideration of susceptibility to harm and capacity to provide free and informed consent. A balanced approach is required when protections are considered, and the benefits as well as the risks of research participation must be carefully weighed. A variety of protections for the vulnerable sick in research are available, including enrolling subjects (...) in a study only with a strong justification, ensuring that consent is free and comprehending, and setting limits on the risk to which they may be asked to endure. Discussion of three contemporary controversies, placebo-controlled trials in the psychiatric setting, phase I clinical trials and oncology patients, and emergency room research involving patients incapable of giving consent, highlights the little recognized prominence of risk-benefit issues in the clinical studies in the vulnerable sick. (shrink)

Winner of the 1975 National Book Award, this brilliant and widely acclaimed book is a powerful philosophical challenge to the most widely held political and social positions of our age--liberal, socialist, and conservative.

A Christian ethicist discusses such problems as organ transplants, caring for the terminally ill, and defining death.

Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

This Hackett edition, first published in 1981, is an unabridged and unaltered republication of the seventh edition as published by Macmillan and Company, Limited. From the forward by John Rawls: In the utilitarian tradition Henry Sidgwick has an important place. His fundamental work, The Methods of Ethics, is the clearest and most accessible formulation of what we may call 'the classical utilitarian doctorine.' This classical doctrine holds that the ultimate moral end of social and individual action is the greatest net (...) sum of the happiness of all sentient beings. Happinesss is specified by the net balance of pleasure over pain, or, as Sidgwick preferred to say, as the net balance of agreeable over disagreeable consciousness.... (shrink)

A Decent Proposal: Ethical Review of Clinical Research Donald Evans and Martyn Evans Centre for Philosophy and Health Care University of Wales Swansea, UK The investigation and development of modern medicines and medical technology can create numerous ethical dilemmas both for clinical researchers and research ethics committees. A Decent Proposal: Ethical Review of Clinical Research seeks to facilitate and encourage good clinical research by exploring the concerns, responsibilities, general issues and particular pitfalls associated with ethical aspects of research. It provides (...) practical guidelines for researchers on how to improve the quality of research design, while for those appointed to scrutinise research proposals it offers advice on how to apply consistent, careful and critical reasoning to the process of assessing ethical standards. As such, it will provide invaluable assistance to clinical researchers and ethics committees alike in understanding the moral challenges posed by modern health care. (shrink)

In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions.

"Well-being," "welfare," "utility," and "quality of life," all closely related concepts, are at the center of morality, politics, law, and economics. Griffin's book, while primarily a volume of moral philosophy, is relevant to all of these subjects. Griffin offers answers to three central questions about well-being: what is the best way to understand it, can it be measured, and where should it fit in moral and political thought. With its breadth of investigation and depth of insight, this work holds significance (...) for philosophers as well as for those interested in political and economic theory and jurisprudence. (shrink)

Bentham's best-known book stands as a classic of both philosophy and jurisprudence. The 1789 work articulates an important statement of the foundations of utilitarian philosophy — it also represents a pioneering study of crime and punishment. Bentham's reasoning remains central to contemporary debates in moral and political philosophy, economics, and legal theory.

This paper is a plea for hedonism to be taken more seriously. It begins by charting hedonism's decline, and suggests that this is a result of two major objections: the claim that hedonism is the 'philosophy of swine', reducing all value to a single common denominator, and Nozick's 'experience machine' objection. There follows some elucidation of the nature of hedonism, and of enjoyment in particular. Two types of theory of enjoyment are outlined-intemalism, according to which enjoyment has some special 'feeling (...) tone'. and externalism, according to which enjoyment is any kind of experience to which we take some special attitude, such as that of desire. lnternalism-the traditional view--is defended against current externalist orthodoxy. The paper ends with responses to the philosophy of swine and the experience machine objections. (shrink)

Classifying research proposals by risk of harm is fundamental to the approval process and the most pivotal risk category in most regulations is that of “minimal risk.” If studies have no more than a minimal risk, for example, a nearly worldwide consensus exists that review boards may sometimes: (1) expedite review, (2) waive or modify some or all elements of informed consent, or (3) enroll vulnerable subjects including healthy children, incapacitated persons and prisoners even if studies do not hold out (...) direct benefits to them. The moral and social purposes behind this threshold are discussed along with relevant views from the National Commission, NBAC, NHRPAC, Grimes v. Kennedy Krieger Institute, The Nuremberg Code, and The WMA's Declaration of Helsinki. Representative policies from Australia, Canada, South Africa, the U.S., and CIOMS are reviewed revealing different understandings of this sorting threshold. Six of nine frequently cited interpretations of “minimal risk” are untenable. The “absolute” interpretation of the “routine examination” standard is defended as best. (shrink)

Can one be ill and happy? I use a phenomenological approach to provide an answer to this question, using Merleau-Ponty’s distinction between the biological and the lived body. I begin by discussing the rift between the biological body and the ill person’s lived experience, which occurs in illness. The transparent and taken for granted biological body is problematised by illness, which exposes it as different from the lived experience of this body. I argue that because of this rift, the experience (...) of illness cannot be captured within a naturalistic view and propose to supplant this view with a phenomenological approach. The latter approach accounts for changes in the ill person’s relationship to her social and physical world. These changes, I argue, cannot be captured by a naturalistic perspective. I then propose the notion of health within illness as a useful concept for capturing the experience of well-being reported by some ill people. I present empirical evidence for this phenomenon and assess its philosophical significance. Finally, I suggest that adaptability and creativity are two common positive responses to illness, demonstrating that health within illness is possible. The three elements combined – the transformed body, health within illness and adaptability and creativity – serve as the basis for a positive answer to the question posed above. (shrink)

Challenging, with several powerful arguments, some of our deepest beliefs about rationality, morality, and personal identity, Parfit claims that we have a false view about our own nature. It is often rational to act against our own best interersts, he argues, and most of us have moral views that are self-defeating. We often act wrongly, although we know there will be no one with serious grounds for complaint, and when we consider future generations it is very hard to avoid conclusions (...) that most of us will find very disturbing. (shrink)