The dead donor rule—that persons must be dead before their organs are taken—is a central part of the moral framework underlying organ procurement. Efforts to increase the pool of transplantable organs have been forced either to redefine death (e.g., anencephaly) or take advantage of ambiguities in the current definition of death (e.g., the Pittsburgh protocol). Society's growing acceptance of circumstances in which health care professionals can hasten a patient's death also may weaken the symbolic importance of the dead donor rule. (...) We consider the implications of these efforts to continually revise the line between life and death and ask whether it would be preferable to abandon the dead donor rule and rely entirely on informed consent as a safeguard against abuse. (shrink)

In the clinical setting, questions of medical ethics raise a host of perplexing problems, often complicated by conflicting perspectives and the need to make immediate decisions. In this volume, bioethicists and physicians provide a nuanced, in-depth approach to the difficult issues involved in bioethics consultation. Addressing the needs of researchers, clinicians, and other health professionals on the front lines of bioethics practice, the contributors focus primarily on practical concerns -- whether ethics consultation is best done by individuals, teams, or committees (...) how an ethics consult service should be structured the need for institutional support and techniques and programs for educating and training staff -- without neglecting more theoretical considerations, such as the importance of character or the viability of organizational ethics. (shrink)

Advertising by health care institutions has increased steadily in recent years. While direct-to-consumer prescription drug advertising is subject to unique oversight by the Federal Drug Administration, advertisements for health care services are regulated by the Federal Trade Commission and treated no differently from advertisements for consumer goods. In this article, we argue that decisions about pursuing health care services are distinguished by informational asymmetries, high stakes, and patient vulnerabilities, grounding fiduciary responsibilities on the part of health care providers and health (...) care institutions. Using examples, we illustrate how common advertising techniques may mislead patients and compromise fiduciary relationships, thereby posing ethical risks to patients, providers, health care institutions, and society. We conclude by proposing that these risks justify new standards for advertising when considered as part of the moral obligation of health care institutions and suggest that mechanisms currently in place to regulate advertising for prescription pharmaceuticals should be applied to advertising for health care services more broadly. (shrink)

Purpose Although surrogate decision-making is prevalent in intensive care units and concerns with decision quality are well documented, little is known about how clinicians help family members understand the surrogate role. We investigated whether and how clinicians provide normative guidance to families regarding how to function as a surrogate. Subjects and methods We audiorecorded and transcribed 73 ICU family conferences in which clinicians anticipated discussing goals of care for incapacitated patients at high risk of death. We developed and applied a (...) coding framework to identify normative statements by clinicians regarding what considerations should guide surrogates’ decisions, including whether clinicians explained one or more of Buchanan and Brock’s three standard principles of SDM to family members. Results Clinicians made at least one statement about how to perform the surrogate role in 24 conferences ). We observed three general types of normative guidance provided to surrogates, with some conferences containing more than one type of guidance: counselling about one or more standard principles of SDM ; counselling surrogates to make decisions centred on the patient as a person, without specifying how to accomplish that ; and counselling surrogates to make decisions based on the family’s values. Conclusions Clinicians did not provide normative guidance about the surrogate role in two-thirds of family conferences for incapacitated patients at high risk for death. When they did, clinicians’ guidance was often incomplete and sometimes conflicted with standard principles of SDM. Future work is needed to understand whether providing explicit guidance on how to perform the surrogate role improves decision-making or mitigates surrogates’ psychological distress. (shrink)

Since the Harvard Committees bold and highly successful attempt to redefine death in 1968 (Harvard Ad Hoc committee, 1968), multiple controversies have arisen. Stimulated by several factors, including the inherent conceptual weakness of the Harvard Committees proposal, accumulated clinical experience, and the incessant push to expand the pool of potential organ donors, the lively debate about the definition of death has, for the most part, been confined to a relatively small group of academics who have created a large body of (...) literature of which this issue of the Journal of Medicine and Philosophy is an example. Law and public policy, however, have remained essentially unaffected. This paper will briefly review the multiple controversies about defining death in an attempt to explain why they have and will remain unresolved in the academic community and have even less chance of being understood and resolved by politicians, legislators, and the general public. Considering this, we will end by suggesting the probable course of public policy and clinical practice in the decades ahead. (shrink)

Empirical research pertaining to cardiopulmonary resuscitation (CPR), clinician behaviors related to do-not-resuscitate (DNR) orders and substituted judgment suggests potential contributions to medical ethics. Research quantifying the likelihood of surviving CPR points to the need for further philosophical analysis of the limitations of the patient autonomy in decision making, the nature and definition of medical futility, and the relationship between futility and professional standards. Research on DNR orders has identified barriers to the goal of patient involvement in these life and death (...) discussions. The initial data on surrogate decision making also points to the need for a reexamination of the moral basis for substituted judgment, the moral authority of proxy decision making and the second-order status of the best interests standard. These examples of empirical research suggest that an interplay between empirical research, ethical analysis and policy development may represent a new form of interdisciplinary scholarship to improve clinical medicine. (shrink)

One way of increasing the supply of vital organs without violating the dead donor rule is to declare death on cardiopulmonary criteria after withdrawing life support. The question then is how quickly death may be declared.

One way of increasing the supply of vital organs without violating the dead donor rule is to declare death on cardiopulmonary criteria after withdrawing life support. The question then is how quickly death may be declared.

Institutional review boards are almost universally considered to be overworked and understaffed. They also require substantial commitments of time and resources from their members. Although some surveys report average IRB memberships of 15 people or more, federal regulations require only five. We present data on IRB meetings at eight of the top 25 academic medical centers in the United States funded by the National Institutes of Health. These data indicate substantial contributions from primary reviewers and chairs during protocol discussions but (...) little from other members, which implies that it may be possible for smaller IRBs to accomplish the same tasks with no reduction in the quality of review. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Back to the Future:Obtaining Organs from Non-Heart-Beating CadaversRobert M. Arnold (bio) and Stuart J. Youngner (bio)Organ Transplantation requires viable donor organs. This simple fact has become the Achilles' heel of transplantation programs. Progress in immunology and transplant surgery has outstripped the supply of available organs. Between 1988 and 1991, for example, the number of transplant candidates on waiting lists increased by about 55 percent, while the number of donors (...) increased only about 16 percent.1 By the end of March 1993, more than 30,000 potential recipients awaited transplantation (United Network for Organ Sharing Database (UNOS) 1993). Every day six of these patients die prior to receiving a heart or liver transplant, while patients needing kidney transplants must tolerate a lower quality of life on dialysis (Grenvik 1992; Evans, Orians, and Ascher 1992).This scarcity is likely to get worse. As transplantation becomes more successful, it is being offered to sicker and older patients. Attempts to transplant other solid organs, such as small bowel and pancreas, will only fuel the demand for donors. However, the current source of organs is unlikely to grow. Most organs come from patients who have been declared dead by neurologic criteria (commonly referred to as "brain dead" or heart-beating cadaver donors (HBCDs) because their hearts are beating at the time of procurement). Estimates of the potential pool of HBCDs have been revised downward from 20,000-27,000 to roughly 10,000-12,000 (Nathan et al. 1991). Improvements in automobile safety and handgun legislation will likely lead to further reductions. Moreover, the rate of procurement from HBCDs has remained relatively flat despite extensive public awareness campaigns and legislation requiring hospitals to routinely request donation from families of dead patients (Caplan et al. 1992).If organ transplantation is going to continue to flourish, alternative [End Page 103] sources of organs must be found. Recently the University of Pittsburgh Medical Center (UPMC) proposed procuring organs from patients who have been declared dead by traditional cardiopulmonary rather than brain-oriented criteria after they or their families have decided to forgo life-sustaining treatment—hereafter referred to as the Pittsburgh protocol (UPMC Policy 1993). These patients are typically referred to as non-heart-beating cadaver donors (NHBCDs) because their hearts are no longer beating at the time of organ procurement.Although NHBCDs were a major source of transplantable kidneys prior to the institution of death by neurologic criteria, their usefulness was limited by "warm ischemia time." This term refers to the injury to tissues that occurs when the blood supply is interrupted and before the organs are cooled and reperfused. Under the Pittsburgh protocol, therapy is withdrawn in the operating room where a waiting surgical team removes organs immediately after death is declared. By controlling the place and time of death, it has been possible to minimize warm ischemia time and thus solve the technical problems previously associated with procurement from NHBCDs.The potential contribution of NHBCD organs is significant. Nathan (1992), using data from Delaware Valley Transplant Program, concludes that the use of severely brain injured, but not "brain dead" patients, would increase the donor pool by 20-25 percent. Moreover, unpublished data from the Pittsburgh organ procurement organization, the Center for Organ Recovery and Education (CORE), suggests that these organs, particularly kidneys, function as well as those procured from HBCDs (Broznick 1993).This volume is devoted to the ethical, psychosocial, and public policy implications of procuring organs from non-heart-beating cadaver donors after a discussion to forgo life-sustaining treatment. The genesis of this volume was a project in which we invited leading experts in transplantation, ethics, and public policy to use the Pittsburgh protocol as a starting point for exploring a broad range of issues associated with attempts to procure organs from NHBCDs. The issues raised by NHBCDs turned out to have important implications about the fundamental conceptual and moral assumptions underlying organ procurement.Although each of the papers in this volume can be read separately, we intend the volume to be read as a whole. Many of the latter pieces on the ethical implications of the policy are best understood in light of the earlier background papers... (shrink)

: In this brief commentary, we reflect on the recent study by Siminoff, Burant, and Youngner of public attitudes toward "brain death" and organ donation, focusing on the implications of their findings for the rules governing from whom organs can be obtained. Although the data suggest that many seem to view "brain death" as "as good as dead" rather than "dead" (calling the dead donor rule into question), we find that the study most clearly demonstrates that understanding an individual's definition (...) of death is neither a straightforward task nor a good predictor of views about donation. Reflecting on the implications for ongoing debates over the dead donor rule, we suggest that perhaps it is not a change in policy that is warranted, but rather a change in the priorities that have garnered such intense focus on this issue within the field of bioethics. (shrink)

Objective: Even when critically ill patients are almost certain to die from their illnesses, there is generally an element of prognostic uncertainty. Little is known about how physicians handle this uncertainty in conversations with surrogate decision makers. We sought to evaluate whether and how physicians discuss prognostic uncertainty with surrogate decision makers of patients who are highly likely, but not certain, to die. Design: We audiotaped and transcribed discussions between clinicians and surrogate decision makers at two major California teaching hospitals (...) from 2006 through 2008. Physicians completed a questionnaire addressing their prognostic estimates for patients' survival to hospital discharge. Participants: We included physicians and surrogates of 12 incapacitated, critically ill patients. Measurements: We analyzed transcripts of discussions in which physicians' estimates of patients' chances of hospital survival were 1% to 5%; we coded whether physicians disclosed the prognostic uncertainty and, if so, how they conveyed that death was highly likely but not certain. Results: Physicians' estimates of short-term survival were 1% to 5% for 12 of the 70 patients enrolled in the original study. In 8 of 12 cases, physicians conveyed prognostic uncertainty by using probabilistic language or by an explicit mention of uncertainty. In four cases, physicians made at least one statement that either implied or was ambiguous about whether death was certain. Conclusion: We observed variability in how physicians handle prognostic uncertainty in their discussions with surrogates of patients who are highly likely, but not certain, to die, including some circumstances in which physicians stated or implied that death was certain. (shrink)

This book explores the relationship between scientific fact and metaphysical reality, offering a fresh perspective on the intersection of these two seemingly disparate fields. This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work is in the "public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual (...) or corporate) has a copyright on the body of the work. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant. (shrink)

In “Bioethics and the Whole: Pluralism, Consensus, and the Transmutation of Bioethical Methods into Gold,” Patricia Martin identifies themes common to three emerging approaches to clinical bioethics--clinical pragmatism, ethics facilitation, and mediation-in order to develop an “ethical consensus method” that can serve as a “practical, step-by-step guide” for decision making She is to be applauded both for her identification of themes common to these three approaches and for her contribution to what we hope will be a growing literature on practical (...) methods for problem solving in clinical bioethics that take seriously the ideal of consensus. After a few preliminary remarks concerning Martin's working model, we focus the majority of our commentary on the notion of “consensus,” which is at the heart of her “ethical consensus method,” and the three approaches from which it is drawn. (shrink)

In “Bioethics and the Whole: Pluralism, Consensus, and the Transmutation of Bioethical Methods into Gold,” Patricia Martin identifies themes common to three emerging approaches to clinical bioethics--clinical pragmatism, ethics facilitation, and mediation-in order to develop an “ethical consensus method” that can serve as a “practical, step-by-step guide” for decision making She is to be applauded both for her identification of themes common to these three approaches and for her contribution to what we hope will be a growing literature on practical (...) methods for problem solving in clinical bioethics that take seriously the ideal of consensus. After a few preliminary remarks concerning Martin's working model, we focus the majority of our commentary on the notion of “consensus,” which is at the heart of her “ethical consensus method,” and the three approaches from which it is drawn. (shrink)

In “Bioethics and the Whole: Pluralism, Consensus, and the Transmutation of Bioethical Methods into Gold,” Patricia Martin identifies themes common to three emerging approaches to clinical bioethics--clinical pragmatism, ethics facilitation, and mediation-in order to develop an “ethical consensus method” that can serve as a “practical, step-by-step guide” for decision making She is to be applauded both for her identification of themes common to these three approaches and for her contribution to what we hope will be a growing literature on practical (...) methods for problem solving in clinical bioethics that take seriously the ideal of consensus. After a few preliminary remarks concerning Martin's working model, we focus the majority of our commentary on the notion of “consensus,” which is at the heart of her “ethical consensus method,” and the three approaches from which it is drawn. (shrink)

The current policy of the National Institute of Health designed to increase the participation of women and minorities is radically different from previous policies designed to protect minorities from abuses in research studies. The principal arguments to support this policy are twofold: 1) Increased representation of minorities and women in research would increase the generalizability of research data and allow for valid analyses of differences in subpopulations; and 2) being in a clinical research study is advantageous to participants regardless of (...) the final research study results. It remains unclear whether minorities find these arguments compelling. Instead of telling minorities that participation in research is good for them, the research community should focus on understanding what minority communities want from clinical research and then tailoring the message to meet this need. Persuasive arguments to promote long-term increased representation of minorities in clinical research must come from within minority communities. (shrink)