Tom Beauchamp

In lieu of an abstract, here is a brief excerpt of the content:The Institute of Medicine’s Report on Non-Heart-Beating Organ TransplantationRoger Herdman (bio), Tom L. Beauchamp (bio), and John T. Potts Jr. (bio)In December 1997, the Institute of Medicine (IOM) released a report on medical and ethical issues in the procurement of non-heart-beating organ donors. This report had been requested in May 1997 by the Department of Health and Human Services (DHHS). We will here describe the genesis of the IOM report, the medical and moral concerns that led the DHHS to sponsor it, the process of producing it, and its conclusions. The analyses, findings, and recommendations of the report are also reviewed, in particular the central issues that led to suggestions for policy changes.Transplantation BackgroundAs a first step, some background in the relevant aspects of organ transplantation will prove useful. For the purposes of this analysis, “transplantation” involves the transfer of cells, tissues, or solid organs from one human to another to replace the structure or function of comparable body components that, through injury or disease, are defective or of inadequate function. The IOM report deals with solid organs, primarily kidneys and livers, whose blood supply is reconnected in the organ recipient, in contrast to cells, like bone marrow, and tissues, like corneas. A variety of donor types exists for organ transplantation, each with particular medical and scientific conditions.Living donors are healthy (and usually genetically related) individuals who volunteer to provide either a whole, paired organ such as a kidney or a section of an organ such as a liver. Cadaver donors are individuals who have died and from whom a full array of organs can be taken. “Heart-beating” cadaver donors are individuals who have suffered “brain death,” that is, irreversible cessation of function of the whole brain including the brain stem; and “non-heart-beating” donors (NHBDs) are individuals who are ill or injured, but not “brain dead,” and who have suffered cardiopulmonary death, that is, irreversible cessation of cardiac and respiratory function. NHBDs can be “controlled,” which means that [End Page 83] they can be sustained by artificial life support systems until a medical and family decision is made to terminate futile life support. This can be done at a scheduled time and in a controlled manner, and organs can then be recovered for transplantation. NHBDs can also be “uncontrolled,” which means that their hearts and breathing have stopped through disease or injury at an unexpected time or in an uncontrolled manner, and they cannot be resuscitated; the organs of some individuals of this description can be recovered for transplantation. The IOM report focused on both controlled and uncontrolled NHBDs and on problems specific to them.The questions that were asked and addressed in the IOM report became current and salient beginning in 1992 with the establishment of the University of Pittsburgh “Policy for the Management of Terminally Ill Patients Who May Become Organ Donors After Death.” This policy addressed controlled NHBDs and the ethical questions raised by their use; much of the discussion was reported in the June 1993 special issue of the Kennedy Institute of Ethics Journal. Public notice and anxiety about some of these concerns were sharpened and refocused by national and local media allegations of improper treatment of donors at the Cleveland Clinic in 1997, specifically premature—i.e., antemortem—recovery of organs and administration of drugs that allegedly might hasten donor death.The DHHS Request for StudyIt is not surprising that several federal actions would be taken in response to these events. Some, such as the results of a transplantation task force, remain largely internal to DHHS at this writing. Others are public, such as the IOM study of the NHBD situation. In May 1997, the DHHS initiated contacts with the IOM with the goal of exploring federal concerns about the medical and ethical treatment of NHBDs, in particular the allegations directed at the Cleveland Clinic.The DHHS response should be understood in at least three contexts. First, living donors and uncontrolled NHBDs were essentially the only donor types in the early days of transplantation in the United States. The technologies, ethics, and social acceptance of controlling and terminating life support for...

Hume wrote about fundamental similarities and dissimilarities between human and nonhuman animals. His work was centered on the cognitive and emotional lives of animals, rather than their moral or legal standing, but his theories have implications for issues of moral standing. The historical background of these controversies reaches to ancient philosophy and to several prominent figures in early modern philosophy. Hume develops several of the themes in this literature. His underlying method is analogical arg ument and his conclusions are generally favorable regarding the abilities in animals. Hume does not attribute a moral sense or capacity of judgment to animals, but he does suggest that their actions exhibit moral qualities, such as other-regarding instincts. Hume allows in-kind differences in both demonstrative reason and moral judgment, but in the domains of both causal reason and moral agency he believes there are differences of degree rather than of kind. Hume's most significant philosophical contribution was to move as far as anyone before him to a naturalistic explanation of human and nonhuman minds that invited psychological and epistemological examination of minds by using the identical methods and categories for man and beast.

Written by epidemiologists, ethicists and legal scholars, this book provides an in-depth account of the moral problems that often confront epidemiologists, including both theoretical and practical issues. The first edition has sold almost three thousand copies since it was published in 1996. This edition is fully revised and includes three new chapters: Ethical Issues in Public Health Practice, Ethical Issues in Genetic Epidemiology, and Ethical Issues in International Health Research and Epidemiology. These chapters collectively address important developments of the past decade. Three chapters from the first edition have also been reorganized: Ethicall Optimized Study Deisgns in Epidemiology, Ethical Issues in Epidemiologic Research with Children, and The Ethics of Epidemiologic Research with Older Populations. Instead of standing alone, these chapters have been integrated into chapters on informed consent, confidentiality and privacy protection, and community-based intervention studies.

L'actuel débat sur l'« égalité face aux soins » et le « droit aux soins » est la conséquence directe des progrès techniques réalisés dans le domaine de la santé, mais il reste encore à fonder rationnellement les politiques suivies en la matière et à formuler une théorie adéquate de la justice distributive. Le présent article analyse le rôle et le statut du droit aux soins, ainsi que les considérations tenant à la justice qui vont à rencontre de la rentabilité et de l'utilité sociales. Les choix de répartition budgétaire sont décisifs pour la formulation de revendications au nom de l'existence d'un droit positif aux soins, et il convient de se demander si un tel droit existe et quelles en sont les limites. Discussions today of « equal access » and « the right to health care » are the direct descendants of advances in the technology of health care, and we are still in search of a rationale for our policies and a theory of distributive justice adequate to the task. The role and status of rights to health care, together with considerations of justice in conflict with social efficiency and utility are discussed in this paper. It is argued that allocation decisions are central to claims on behalf of a positive right to health care, which forces questions both of whether there is such a right and of the limits to the right.

Western ethics and law have been slow to come to conclusions about the right to choose the time and manner of one's death. However, policies, practices, and legal precedents have evolved quickly in the last quarter of the twentieth century, from the forgoing of respirators to the use of Do Not Resuscitate (DNR) orders, to the forgoing of all medical technologies (including hydration and nutrition), and now, in one U.S. state, to legalized physician-assisted suicide. The sweep of history—from the Quinlan case in New Jersey to legislation in Oregon that allows physician-assisted suicide—has been as rapid as it has been revolutionary.

The last twenty-five years of published literature and curriculum development in bioethics suggest that the field enjoys a successful and stable marriage to philosophical ethical theory. However, the next twenty-five years could be very different. I believe the marriage is troubled. Divorce is conceivable and perhaps likely. The most philosophical parts of bioethics may retreat to philosophy departments, while bioethics continues on its current course toward a more interdisciplinary and practical field.I make no presumption that bioethics is integrally linked to philosophical ethical theory. Indeed, I assume that the connection is contingent and fragile. Many individuals in law, theological ethics, political theory, the social and behavioral sciences, and the health professions carefully address mainstream issues of bioethics without finding ethical theory essential or breathtakingly attractive. This is not surprising. Moral philosophers have traditionally formulated theories of the right, the good, and the virtuous in the most general terms.

What is the organizational structure of Hume’s essay? The first three paragraphs are purely introductory and somewhat incidental. To someone untutored in Hume’s general religious skepticism, these opening remarks might appear to be the vain boasts of a philosopher in praise of philosophy. More plausibly, his opening remarks are stage-setting devices. They prepare the reader not for what Hume will argue but rather for how he will uncompromisingly challenge commonly held presuppositions about the sensitive issue of suicide. His comments are methodological or perhaps meta-philosophical in character. In more contemporary language, Hume is promoting the following two theses in these introductory paragraphs, each of which has to do with the inadequacy of non-philosophical foundations for reaching conclusions about the morality of suicide.

What grounds and justifies conclusions in medical ethics? Is the source external or internal to medicine? Thee influential types of answer have appeared in recent literature: an internal account, an external account, and a mixed internal / external account. The first defends an ethic derived from either the ends of medicine or professional practice standards. The second maintains that precepts in medical ethics rely upon and require justification by external standards such as those of public opinion, law, religious ethics, or philosophical ethics. The third claims that distinct medical ethics have emerged from distinct cultural frameworks, each with norms that govern physicians. There is merit in each perspective, but each overreaches its supporting arguments and fails to appreciate what is legitimate in the theses of its competitors. I propose a fourth account that offers a way to escape limitations of the other three, while retaining their most attractive features.

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.4 (2002) 389-390 [Access article in PDF] IOM Report on the System for Protecting Human Research Participants Tom L. Beauchamp* In response to society's concerns about the use of human subjects in research, the Department of Health and Human Services commissioned the Institute of Medicine to perform a comprehensive assessment of current systems of research participant protection in the U.S., including recommendations for reform (Committee 2002). Although the committee declared its frustration over the lack of data, it found ample evidence to indicate that there are pivotal weaknesses in the current system. First, it discovered dissatisfaction with the current system from virtually every quarter and at virtually every level. Second, it found evidence that IRBs are under severe strain and performing inadequately. Third, it found that the existing regulatory framework—the IRB system and the Common Rule—has not and probably now cannot react adequately to the constantly evolving research environment. Some of these problems might be handled through federal agencies, but the committee holds that the problems are more extensive and will require additional institutional support and professional attention.The committee found that federal protection requirements should be extended to every research project—private, public, or otherwise. Subjects should be, in this respect, equally protected in privately sponsored research.The committee found that the IRB system is in important respects a failure, especially when it alone is relied upon for ethics reviews in institutions. One set of problems concerns the proper education of IRB members. The committee recommends that all members henceforth be given a specialized knowledge of human research ethics. It finds that IRB deliberations commonly have been dominated by scientists, who often marginalize the perspectives of nonscientist members. It therefore recommends that unaffiliated members, nonscientists, local community representatives, and those representing the participant-perspective comprise at least 25 percent of the membership. It also recommends that no protocol be approved without three-quarters of the voting members concurring. [End Page 389]The committee recommends that institutions distinguish review aimed at (1) scientific merit, (2) conflict of interest, and (3) general Ethics Review. The distinction should more evenly distribute the work of institutional ethics review. The IRB should not conduct the initial scientific review nor should it be spending the bulk of its time purely in examining either scientific merit—as many IRBs now do—or conflict of interest. Instead, the conclusions of the scientific review should be submitted to the IRB for ethics-focused deliberations. Problems of both financial and nonfinancial conflicts of interest should be handled similarly, preferably by a committee properly distanced from the institution's interests.The committee underscores that consent must be understood on the model of an interactive dialogue between research staff and participants and not merely as a signed form or single-disclosure event. Conversations between the participant and the research staff should begin even prior to the point of enrollment and should be reinforced during each stage of the research. The committee finds that informed consent conversations and documents too often are being conceived as risk management tasks gauged to protect the institution from liability.The committee also believes that the system of protections established by a research program should be open to the public in order to foster and maintain the community's trust. Open communication should occur among all relevant stakeholders. The committee notes that currently no centralized system exists for the dissemination of information about clinical trials and other research activities.It urges reconsideration of present policies regarding compensation, finding that many research organizations provide at least short-term medical care for those who are injured, but that few organizations cover all potential risks and that many organizations have no effective policy of compensation. The report holds that providing reasonable compensation for bona fide instances of research harm is the only just system and is necessary to avoid diminished public trust.The committee holds that establishing the appropriate culture in research institutions will require sustained efforts to educate researchers, research administrators, IRB members, and...

On December 15, 2011, a final report was issued by the Committee on the Use of Chimpanzees in Biomedical and Behavioral Research, which had been convened by the U. S. Institute of Medicine (IOM) in collaboration with National Research Council (NRC) of the National Academies. Within a month of its release, this report was designated by Wired Science one of the “top scientific discoveries of 2011” (Wired Science Staff 2011). The ad hoc Committee responsible for this report was formed at the request of the National Institutes of Health (NIH) in response to congressional inquiry that had been prompted by expressions of public concern.1 The issues addressed in the report are profoundly ethical, despite NIH’s..

This accessible overview of classical and modern moral theory with short readings provides comprehensive coverage of ethics and unique coverage of rights, justice, liberty and law. Real-life cases introduce each chapter. While the book's content is theoretical rather than applied ethics, Beauchamp consistently applies the theories to practical moral problems. Aristotle, Hume, Kant, and Mill are at the book;s core and they are placed in the context of moral philosophical controversies of the last 30 years. In this edition one-third of the reading selections are new and all the selections in chapter 8 on rights are new. Chapter 7 on Hume has been heavily reshaped. Chapter 1 has been reduced to get students past introductory material and into the philosophers.

To address some questions in global biomedical ethics, three problems about cultural moral differences and alleged differences in Eastern and Western cultures are addressed: The first is whether the East has fundamentally different moral traditions from those in the West. Concentrating on Japan and the United States, it is argued that theses of profound and fundamental East-West differences are dubious because of many forms of shared morality. The second is whether human rights theory is a Western invention with no firm traditions in Eastern moral traditions. It is argued that this thesis is unsupported both historically and in contemporary bioethics. The third problem is whether multiculturalist theory casts doubt on claims of universal principles and rights. It is argued that the reverse is true: multiculturalism is a universalistic theory. The argument throughout supports common morality theory.

The first set of case studies on animal use, this volume offers a thorough, up-to-date exploration of the moral issues related to animal welfare. Its main purpose is to examine how far it is ethically justifiable to harm animals in order to benefit mankind. An excellent introduction provides a framework for the cases and sets the background of philosophical and moral concepts underlying the subject. Sixteen original, previously unpublished essays cover controversies associated with the human use of animals in a broad range of contexts, including biomedical, behavioral, and wildlife research, cosmetic safety testing, education, the food industry, commerce, and animal use as pets and in religious practices. Scientific research is accorded the closest scrutiny. The authors represent a wide range of expertise within their specialized areas of research--physiology, public policy, ethics, philosophy, law, veterinary science, and psychology. The careful analysis of each case makes it possible to elevate the discourse beyond over-simplified positions, and to demonstrate the complexity of the issues. The Human Use of Animals will be welcomed by students and faculty in law, philosophy, ethics, public policy, religion, medicine, and veterinary medicine. It will also interest activists in the animal protection movement, and members of animal protection organizations and Institutional Animal Care and Use Committees.

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion.