Since it appeared in 1971, John Rawls's A Theory of Justice has become a classic. The author has now revised the original edition to clear up a number of difficulties he and others have found in the original book. Rawls aims to express an essential part of the common core of the democratic tradition--justice as fairness--and to provide an alternative to utilitarianism, which had dominated the Anglo-Saxon tradition of political thought since the nineteenth century. Rawls substitutes the ideal of the (...) social contract as a more satisfactory account of the basic rights and liberties of citizens as free and equal persons. "Each person," writes Rawls, "possesses an inviolability founded on justice that even the welfare of society as a whole cannot override." Advancing the ideas of Rousseau, Kant, Emerson, and Lincoln, Rawls's theory is as powerful today as it was when first published. (shrink)

Many believe that we ought to save a large number from being permanently bedridden rather than save one from death. Many also believe that we ought to save one from death rather than a multitude from a very minor harm, no matter how large this multitude. I argue that a principle I call “Aggregate Relevant Claims” satisfactorily explains these judgments. I offer a rationale for this principle and defend it against objections.

A predominant ethical view holds that physician‐investigators should conduct their research with therapeutic intent. And since a physician offering a therapy wouldn't prescribe second‐rate treatments, the experimental intervention and the best proven therapy should appear equally effective. "Clinical equipoise" is necessary. But this perspective is flawed. The ethics of research and of therapy are fundamentally different, and clinical equipoise should be abandoned.

: Bioethicists have failed to understand the pervasively paternalistic character of research ethics. Not only is the overall structure of research review and regulation paternalistic in some sense; even the way informed consent is sought may imply paternalism. Paternalism has limits, however. Getting clear on the paternalism of research ethics may mean some kinds of prohibited research should be reassessed.

: When may a physician legitimately offer enrollment in a randomized clinical trial (RCT) to her patient? Two answers to this question have had a profound impact on the research ethics literature. Equipoise, as originated by Charles Fried, which we term Fried's equipoise (FE), stipulates that a physician may offer trial enrollment to her patient only when the physician is genuinely uncertain as to the preferred treatment. Clinical equipoise (CE), originated by Benjamin Freedman, requires that there exist a state of (...) honest, professional disagreement in the community of expert practitioners as to the preferred treatment. FE and CE are widely understood as competing concepts. We argue that FE and CE offer separable and, in themselves, incomplete justifications for the conduct of clinical trials. FE articulates conditions under which the fiduciary duties of physician to patient may be upheld in the conduct of research. CE sets out a standard for the social approval of research by institutional review boards. Viewed in this way, FE and CE are not necessarily competing notions, but rather address complementary moral concerns. (shrink)

Utilitarianism has a curious history. Its most celebrated founders—Jeremy Bentham and John Stuart Mill—were radical progressives, straddling the worlds of academic philosophy, political science, economic theory and practical affairs. They made innumerable recommendations for legal, social, political and economic reform, often (especially in Bentham’s case) described in fine detail. Some of these recommendations were followed, sooner or later, and many of their radical ideas have become close to articles of faith of western liberalism. Furthermore many of these recommendations were made (...) expressly to improve the condition of the deprived, or of oppressed groups. Yet the moral theory which inspired this reforming zeal is, at least officially, utilitarianism, and when we teach this theory to our students we feel it our duty to point out the horrors that could be justified by any theory which assesses the moral quality of actions in terms of the maximization of good consequences over bad. No consequence is so bad that it cannot, in principle, be outweighed by a large aggregation of smaller goods. Hence there are circumstances in which utilitarianism can require slavery, the punishment of the innocent, and redistribution of resources from the poor to the rich, or from the disabled and the sick to the able bodied and healthy. Indeed, in the right circumstances, it can justify pretty much anything you can think of. For all their intelligence and imagination neither Bentham nor Mill seemed to recognise or discuss these catastrophic possibilities. (shrink)

The clinical trial is the major investigational tool of clinical medicine. Two recent reports highlight the fact that the most often quoted mechanisms for the protection of research subjects, viz., research ethics board review and eligibility criteria, are insufficient to achieve this end. In this paper, we argue that the prime mechanism for the protection of persons in clinical trials should be the clinical judgement of the physician-investigator. The clinical investigator has a duty to protect subjects from both harm and (...) undue risk. It is argued that the clinical investigator has a duty to screen for, and exclude, potential research subjects who may be unduly vulnerable to the risks of a particular clinical trial. In order to fulfill this obligation, the investigator should personally screen each potential research subject at the time of accrual. In larger trials in which this is not feasible, this task could be delegated to another appropriately qualified health care professional, with the principal investigator retaining personal responsibility. To reinforce and make explicit this legal and moral duty, we propose that the investigator sign a statement, appended to each subject's consent form, to attest that this duty has been responsibly discharged. (shrink)