Western society today is less unified by a set of core values than ever before. Undoubtedly, the concept of moral consensus is a difficult one in a liberal, democratic and pluralistic society. But it is imperative to avoid a rigid majoritarianism where sensitive personal values are at stake, as in bioethics. Bioethics has become an influential part of public and professional discussions of health care. It has helped frame issues of moral values and medicine as part of a more general (...) effort to find consensus about some of the most perplexing questions of our time. But why is it thought that a moral consensus is important or that it deserves respect? How does moral consensus acquire legitimacy in a society that includes diverse value systems? How is moral consensus possible and how do small groups help create or distort consensus processes? Written by a medical school professor trained in philosophy, this timely work tackles these questions from philosophical, historical, and social scientific standpoints. It begins by describing the traditional ambivalence about consensus in Western culture as well as the uncertain relationship in modernity between consensus and expertise. After outlining the current bioethical consensus, the book gives philosophical and political analyses of the idea of consensus, then assesses the role of consensus in national ethics commissions and in the ethics committee movement. Moreno constructs an original, naturalistic philosophy of moral consensus, referred to as "bioethical naturalism", and then applies sociology and social psychology to actual consensus processes. The book concludes with an account of bioethics as a consensus-oriented social reform movement. This insightful volume will be essential reading for bioethicists, philosophers, physicians, members of ethics committees, and all those concerned with ethical and social issues in health care. (shrink)

Justifying his proposal for “health savings accounts,” which would allow individuals to set aside tax-free dollars against future healthcare needs, President Bush has said that “Health savings accounts all aim at empowering people to make decisions for themselves.” Who could disagree with such a sentiment? Although bioethicists may be among those who express skepticism that personal health savings accounts will be part of the needed “fix” of our healthcare financing system, self determination has long been part of their mantra. Indeed, (...) the field of bioethics played an important role in advancing this idea in the medical world when physician paternalism was regnant. Has its popularity caused it to become so vapid as to be ripe for misuse? (shrink)

Although the neoconservative movement has come to dominate American conservatism, this movement has its origins in the old Marxist Left. Communists in their younger days, as the founders of neoconservatism, inverted Marxist doctrine by arguing that moral values and not economic forces were the primary movers of history. Yet the neoconservative critique of biotechnology still borrows heavily from Karl Marx and owes more to the German philosopher Martin Heidegger than to the Scottish philosopher and political economist Adam Smith. Loath to (...) identify these sources - or perhaps unaware of them - neoconservatives do not acknowledge these intellectual underpinnings or their implications. Thus, in the final analysis, their critique is incoherent and even internally inconsistent. By not acknowledging and embracing their intellectual roots, neoconservatives are left with a deeply ambivalent and often confused view of biotechnology and the society that gives rise to it. (shrink)

Bioethics as a field has been fortunate that its values and concerns have mirrored the values and concerns of society. In light of the September 11th attacks, it is possible that we are witnessing the beginning of a transition in American culture, one fraught with implications for bioethics. The emphasis on autonomy and individual rights may come to be tempered by greater concern over the collective good. Increased emphasis on solidarity over autonomy could greatly alter public response to research abuses (...) aimed at defense from bioterrorism, to privacy of genetic information, and to control of private medical resources to protect the public health. (shrink)

On September 4, 2001, press reports indicated that the Defense Intelligence Agency of the U.S. Department of Defense planned to reproduce a strain of anthrax virus suspected of being held in Russian laboratories. According to the same reports, the Central Intelligence Agency, under the auspices of Project Clear Vision, is engaged in building replicas of bomblets believed to have been developed by the former Soviet Union. These small bombs were designed to disperse biological agents, including anthrax. Government attorneys were said (...) to be confident that, because these projects were designed to develop defensive measures, they were not in violation of the 1972 Biological and Toxin Weapons Convention. (shrink)

If economics has been the “dismal science” of the past century, health policy promises to be that of the next. Health policy issues evoke far less passion than the emotion-laden immediacies of bedside decision making. Nevertheless, it is patent that “macro” issues in all their obscurity and complexity are unavoidable if the health care delivery system of the future is to be fiscally sound and publicly acceptable. In addition, as Americans are now learning, options for care at the bedside are (...) ineluctably constrained by seemingly distant societal choices. (shrink)

Consensus is commonly identified as the goal of ethics committee deliberation, but it is not clear what is morally authoritative about consensus. Various problems with the concept of an ethics committee in a health care institution are identified. The problem of consensus is placed in the context of the debate about realism in moral epistemology, and this is shown to be of interest for ethics committees. But further difficulties, such as the fact that consensus at one level of discourse need (...) not imply consensus at another, oblige us to look more closely at the deliberative process itself. That yields two complementary methods of deliberation that have proven their worth. Finally, placing ethics committees in the context of Dewey's philosophy of social intelligence suggests that consensus should be regarded primarily as a condition rather than as the goal of inquiry. Keywords: ethics committee, consensus, moral authority CiteULike Connotea Del.icio.us What's this? (shrink)

Timely and provocative essays on bioethical questions brought to the forefront by the bioterrorist threat.

Henry Knowles Beecher, an icon of human research ethics, and Timothy Francis Leary, a guru of the counterculture, are bound together in history by the synthetic hallucinogen lysergic acid diethylamide. Beecher was a U.S. Army Lieutenant Colonel who received five battle stars, was inducted into the Legion of Merit, held the first endowed chair in his discipline, wrote at least three path-breaking papers, and is honored by two prestigious ethics awards in his name. Leary was a West Point dropout who (...) was obliged to leave a research assistant professorship, was convicted of violating the Marihuana Tax Act, was sentenced to 20 years in prison and broke out with the... (shrink)

Following a brief account of the puzzle that ethics committees present for the Western Philosophical tradition, I will examine the possibility that social contract theory can contribute to a philosophical account of these committees. Passing through classical as well as contemporary theories, particularly Rawls' recent constructivist approach, I will argue that social contract theory places severe constraints on the authority that may legitimately be granted to ethics committees. This, I conclude, speaks more about the suitability of the theory to this (...) level of analysis than about the ethics committee phenomenon itself. Keywords: ethics committees, moral consensus, social contract theory CiteULike Connotea Del.icio.us What's this? (shrink)

In 1962, Harvard professor of anesthesiology Henry Beecher wrote to Senator Estes Kefauver about certain additions to the federal Food and Drug Act then being considered. According to The Antibiotic Era, the Maryland congressman Samuel Friedel had introduced language that would require informed consent in clinical research. Beecher joined a number of other distinguished medical scientists warning that such a requirement would “cripple” American medical research. A year before, Beecher had protested the U.S. Army's inclusion of the Nuremberg Code in (...) its contracts. Beecher's commitment to a medical ethics of virtue rather than one of oversight suggests that he was a far more interesting person than the cardboard cutout so often vaguely referenced in bioethics as an icon of the rights of human subjects. His thinking about research ethics was rooted in his post‐World War II laboratory work with LSD. (shrink)

This article is based on a public lecture hosted by the Monash University Centre for Human Bioethics in Melbourne, Australia on 11 April 2013. The lecture recording was transcribed by Vicky Ryan; and, the original transcript has been edited — for clarity and brevity — by Vicky Ryan, Michael Selgelid and Jonathan Moreno.

It has been a pleasure to read these papers and to contemplate their importance for what I believe to be a useful and provocative prism though which to view the field of bioethics: the nature of moral consensus. In my own most extended contribution to this literature, DecidingTogether, I did not attempt to prescribe so much as to understand the role of moral consensus in the practice of bioethics. At the end of the book, I expressed the hope that it (...) might help trigger an examination of bioethics and moral consensus. Though a few others shared my interest at that time (in particular Tris Engelhardt, for whose early encouragement I remain deeply grateful), with this set of stimulating papers the conversation has finally begun in earnest. (shrink)

Federal policies on human subjects research have performed a near‐about face. In the 1970s, policies were motivated chiefly by a belief that subjects needed protection from the harms and risks of research. Now the driving concern is that patients, and the populations they represent, need access to the benefits of research.

In her foreword to Science Next, Elizabeth Edwards wrote of science as a tool for social progress: "Innovation is not simply the abstract victory of knowledge [or] the research that gave me years to live; the next science can advance human flourishing and serve the common good. That's the kind of world I want to leave for my children, and for yours." With these words, she joined a tradition that goes back to America's founders, who saw America itself as a (...) "great experiment." Yet while no one can deny that science undergirds the American Dream, it has long been fertile terrain for the "culture wars." Along with arguing the pros and cons of abortion and healthcare, policymakers must now grapple with advancements that raise questions about what it means to be human: we've decoded the genome, but should we modify it to enhance certain "desirable" traits? If we can, should we prolong life at any cost? Will we soon be counting robots, cyborgs, and chimeras among our friends and family?The first book to unpack our love/hate relationship with science from our country's origins to today, The Body Politic is essential reading for science buffs and concerned citizens alike.Jonathan D. Moreno is editor of the Center for American Progress' online magazine Science Progress and professor of bioethics at the University of Pennsylvania. Author and editor of many seminal books and articles on science and science policy, he divides his time between Philadelphia, PA, and Washington, DC. (shrink)

it is mandatory that in building up our strength, we enlarge upon our technical superiority by an accelerated exploitation of the scientific potential of the United States and our allies. National Security Council, NSC-G8: United States Objectives and Program for National Security April 14, 1950 Innovation within the armed forces will rest on experimentation with new approaches to warfare, strengthening joint operations, exploiting U.S. intelligence advantages, and takingfull advantage of science and technology. George W Bush, The National Security Strategy of (...) the United States of America, September 17,2002. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:IRBs Under the MicroscopeJonathan D. Moreno (bio)The spring and summer of 1998 were seasons in the sun for institutional review board (IRB) aficionados. Rarely have the arcana of the local human subjects review panels been treated to so much attention in both the executive and the legislative branches of government, not only at the federal but also at the state level. And it looks as if the attention (...) will continue for some time. The spate of interest is due to a series of coincidences: a powerful House of Representatives subcommittee held hearings after its chairman learned about the IRB system during a previous session on research in underdeveloped communities; the Department of Health and Human Services’s Inspector General (DHHS-IG) released a report on IRBs; the National Institutes of Health (NIH) Office of Extramural Research completed a report on clinical trial monitoring; the National Bioethics Advisory Commission (NBAC) readied a report on research involving persons with mental disorders; the states of Maryland and New York completed studies of research with subjects who lack decision-making capacity; and advocacy groups protested a psychiatric research project involving inner city children.Underlying these proximate causes for the IRB blitz is a growing realization that the already considerable clinical trial enterprise will expand significantly over the next few years. Congress is talking about giving the politically popular NIH half again the budget it currently receives, which in turn will stimulate more commercially supported research. The director of the National Cancer Institute is considering a five-fold increase in the number of subjects enrolled in oncology studies over the next several years. Phase I cancer studies are among the most ethically sensitive, so IRBs will have more work cut out for them if this goal is reached. Adding to the rush of interest in IRBs are the government’s recent apology to the survivors of the syphilis study in Tuskegee, continuing congressional dissatisfaction with the way the Pentagon handled its vaccine distribution during the Gulf War, and the controversy about AZT trials in developing countries.On the HillCongressman Christopher Shays, the moderate Connecticut Republican who has developed an interest in human research issues, convened hearings on human [End Page 329] subjects research and the IRB system on 11 June 1998. Shays chairs the House Government Reform/Human Resources Subcommittee. The committee’s ranking minority member is Edolphus Towns of Brooklyn, NY, who shares Shays’s interest in this area.The immediate rationale for the hearings was the release that day of the DHHS-IG report, Institutional Review Boards: A Time for Reform. The subtitle was changed from A System in Jeopardy apparently after some people in DHHS expressed reservations about its seemingly alarmist tone, but the IG staffers who testified before Shays’s subcommittee insisted that they stood behind the message that the IRB system is in trouble if considerable reforms are not undertaken. Among the factors in the research environment cited as support for the bleak forecast: managed care, commercialization, multi-site trials, high IRB workloads, minimal IRB oversight of approved studies, conflicts of interest, insufficient training of IRB members and investigators, and lack of IRB self-studies (DHHS-IG 1998).As is normally the case for congressional oversight hearings, the first panel of witnesses consisted of executive branch officials, including Eric Meslin, Executive Director of the National Bioethics Advisory Commission, and Gary Ellis, Director of the Office for Protection from Research Risks (OPRR). Shays pressed Ellis on the extent to which OPRR conducts on-site investigations of complaints about abuse of human subjects. Admitting that on-site investigations are rare, Ellis suggested that the agency is inadequately staffed to follow up on complaints as quickly as it might wish. The members of Congress who were present at the hearings generally expressed concern about the DHHS-IG’s findings.The second panel that day, which Shays was unable to attend, set a different tone. Four of the panelists—Paul Appelbaum of the University of Massachusetts at Worcester, Robert Levine of Yale University, Angela Bowen of the Western IRB (a private clinical trials review firm), and I—were invited as authorities on the current condition of the IRB system. Bert Spilker... (shrink)

Leading scholars debate politically progressive perspectives on bioethics and the implications for society, politics, and science in the twenty-first century.

Accustomed as many of us have become in the era of clinical bioethics to the idea of a “hospital philosopher”, on reflection the historical novelty of the role is astonishing, as are its ambiguities. As a result of considering my own experience I found myself writing this miniature intellectual autobiography. In the course of this essay I raise two specific questions: what can the Western philosophical tradition contribute to the clinical setting; and (a question that is rarely asked), what are (...) the implications of this experience for that tradition? (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each school (...) in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

The authors consider the nature of explanatory models in the social sciences in order to suggest ways in which conceptual systems differ. They suggest that, in many cases, theorists, researchers and clinicians can utilize insights from rival models in building their own models, without sacrificing the integrity of their own work.

Physicians have long tinkered with ways to "improve" the human brain, but as our understanding of that organ's inner workings quickly grows, artificial enhancement is becoming more feasible. Military research is at the forefront of this work, much of it focused on drugs. The goal is to produce a better soldier, but the emerging techniques could just as easily be applied to any individual. The military wants to juice up personnel's brains because the human being is the weakest instrument of (...) warfare. Although for centuries astonishing and terrifying advances have been made in the technology of conflict, soldiers are basically the same. They must eat, sleep, discern friend from foe, heal when wounded, and so forth. The first state actor to build superior fighters will make an enormous leap in the arms race. In the short run, researchers are trying to devise aids that would overcome a person's inherent limitations, such as mental fatigue. Long-term results could lead to individuals everywhere who are tireless, less fearful or even better speakers. (shrink)