Jonathan Moreno

Substantial efforts have recently been made to reform the physician-patient relationship, particularly toward replacing the `silent world of doctor and patient' with informed patient participation in medical decision-making. This 'new ethos of patient autonomy' has especially insisted on the routine provision of informed consent for all medical interventions. Stronly supported by most bioethicists and the law, as well as more popular writings and expectations, it still seems clear that informed consent has, at best, been received in a lukewarm fashion by most clinicians, many simply rejecting what they commonly refer to as the `myth of informed consent'. The purpose of this book is to defuse this seemingly intractable controversy by offering an efficient and effective operational model of informed consent. This goal is pursued first by reviewing and evaluating, in detail, the agendas, arguments, and supporting materials of its proponents and detractors. A comprehensive review of empirical studies of informed consent is provided, as well as a detailed reflection on the common clinician experience with attempts at informed consent and the exercise of autonomy by patients. In the end, informed consent is recast as a management tool for pursuing clinically and ethically important goods and values that any clinician should see as meriting pursuit. Concurrently, the model incorporates a flexible, anticipatory approach that recognizes that no static, generic ritual can legitimately pursue the quite variable goods and values that may be at stake with different patients in different situations. Finally, efficiency of provision is addressed by not pursuing the unattainable and ancillary. Throughout, the traditional principle of beneficence is appealed to toward articulating an operational model of informed consent as an intervention that is likely to change outcomes at the bedside for the better

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?

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

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...

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.

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.

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

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.

_Just Doctoring_ draws the doctor-patient relationship out of the consulting room and into the middle of the legal and political arenas where it more and more frequently appears. Traditionally, medical ethics has focused on the isolated relationship of physician to patient in a setting that has left the physician virtually untouched by market constraints or government regulation. Arguing that changes in health care institutions and legal attention to patient rights have made conventional approaches obsolete, Troyen Brennan points the way to a new, more aware and engaged medical ethics. The medical profession is no longer isolated, even theoretically, from the liberal, market-dominated state. Old ideas of physician beneficence and altruism must make way for a justice-based medical ethics, assuming a relationship between equals more compatible with liberal political philosophy. Brennan offers clinical examples of many of today's most challenging medical problems—from informed consent to care rationing and the repercussions of the HIV epidemic—and gives his recommendation for a new ethical perspective. This lively and controversial plea for a rethinking of medical ethics goes right to the heart of medical care at the end of the twentieth century.

Recent efforts to support state regulation of risky behavior like cigarette smoking, alcohol consumption, driving without seatbelts and riding motorcycles without helmets have focused on economic justifications—the costs to society of the consequences of these activities. However, opponents have successfully argued that the economic burdens of regulation outweigh the social benefits. To reduce the toll on society of these behaviors, we need justification for regulation that asserts the moral primacy of health and the well‐being of the community.

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?

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