Tom Beauchamp

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...

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.

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.

: The Advisory Committee on Human Radiation Experiments has correctly argued that persons and institutions can sometimes be held responsible for actions taken more than a half-century ago, when practices and policies on the use of research subjects were strikingly different. In reaching its conclusions, the Committee did not altogether adhere to the language and commitments of its own ethical framework. In its Final Report, the Committee emphasizes judgments of wrongdoing, to the relative neglect of culpability; it discusses mitigating conditions that are exculpatory, but does not provide a thoroughgoing assessment of either culpability or exculpation. However, the Committee's shortcomings are mild in comparison to the deficiencies in the "Report of the UCSF Ad Hoc Fact Finding Committee on World War II Human Radiation Experiments" of the University of California at San Francisco. The latter report reaches no significant judgments of either wrongdoing or culpability. The findings that should have been reached by both committees are discussed

: Phenomena of moral conflict and disagreement have led writers in ethics to two antithetical conclusions: Either valid moral distinctions hold universally or they hold relative to a particular and contingent moral framework, and so cannot be applied with universal validly. Responding to three articles in this issue of the Journal that criticize his previously published views on the common morality, the author maintains that one can consistently deny universality to some justified moral norms and claim universality for others. Universality is located in the common morality and nonuniversality in other parts of the moral life, called "particular moralities." The existence of universal moral standards is defended in terms of: (1) a theory of the objectives of morality, (2) an account of the norms that achieve those objectives, and (3) an account of normative justification (both pragmatic and coherentist).

Robert Baker and Laurence McCullough argue that the "applied ethics model" is deficient and in need of a replacement model. However, they supply no clear meaning to "applied ethics" and miss most of what is important in the literature on methodology that treats this question. The Baker-McCullough account of medical and applied ethics is a straw man that has had no influence in these fields or in philosophical ethics. The authors are also on shaky historical grounds in dealing with two problems: (1) the historical source of the notion of "practical ethics" and (2) the historical source of and the assimilation of the term "autonomy" into applied philosophy and professional ethics. They mistakenly hold (1) that the expression "practical ethics" was first used in a publication by Thomas Percival and (2) that Kant is the primary historical source of the notion of autonomy as that notion is used in contemporary applied ethics.

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.

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.