The irreversibility of death: reply to Cole

Professor Cole is correct in his conclusion that the University of Pittsburgh Medical Center (UPMC) protocol does not violate requirements of "irreversibility" in criteria of death, but wrong about the reasons. "Irreversible" in this context is best understood not as an ontological or epistemic term, but as an ethical one. Understood that way, the patient declared dead under the protocol is "irreversibly" so, even though resuscitation by medical means is still possible. Nonetheless, the protocol revives difficult questions about our concept of death.     

Procuring organs from a non-heart-beating cadaver: a case report

Organ transplantation is an accepted therapy for major organ failure, but it depends on the availability of viable organs. Most organs transplanted in the U.S. come from either "brain-dead" or living related donors. Recently organ procurement from patients pronounced dead using cardiopulmonary criteria, so-called "non-heart-beating cadaver donors" (NHBCDs), has been reconsidered. In May 1992, the University of Pittsburgh Medical Center (UPMC) enacted a new, complicated policy for procuring organs from NHBCDs after the elective removal of life support. Seventeen months later only one patient has become a NHBCD. This article describes her case and the results of interviews with the health care team and the patient's family. The case and interviews are discussed in relation to several of the ethical concerns previously raised about the policy, including potential conflicts of interest, the definition of cardiopulmonary death, and a possible net decrease in organ donation. The conclusion is reached that organ procurement from non-heart-beating cadavers is feasible and may be desirable both for the patient's family and the health care providers.     

Development of the University of Pittsburgh Medical Center policy for the care of terminally ill patients who may become organ donors after death following the removal of life support

In the mid 1980s it was apparent that the need for organ donors exceeded those willing to donate. Some University of Pittsburgh Medical Center (UPMC) physicians initiated discussion of possible new organ donor categories including individuals pronounced dead by traditional cardiac criteria. However, they reached no conclusion and dropped the discussion. In the late 1980s and the early 1990s, four cases arose in which dying patients or their families requested organ donation following the elective removal of mechanical ventilation. Controversy surrounding these cases precipitated open discussion of the use of organ donors pronounced dead on the basis of cardiac criteria. Prolonged deliberations by many committees in the absence of precedent ultimately resulted in what is, to our knowledge, the country's first policy for organ donation following elective removal of life support. The policy is intricate and conservative. Care was taken to include as many interested parties as possible in an effort to achieve representative and broad based support. This paper describes the development of the UPMC policy on non-heart-beating organ donation.     

"An ignoble form of cannibalism": reflections on the Pittsburgh protocol for procuring organs from non-heart-beating cadavers

The author discusses the ways in which she finds the University of Pittsburgh Medical Center protocol for procuring organs from "non-heart-beating cadaver donors" medically and morally questionable and irreverent. She also identifies some of the factors that contributed to the composition of this troubling protocol, and to its institutional approval.     

Non-heart-beating donors of organs: are the distinctions between direct and indirect effects & between killing and letting die relevant and helpful?

This essay analyzes the principle of double effect and, to a lesser extent, the distinction between killing and letting die in the context of the Pittsburgh protocol for managing patients who may become non-heart-beating donors or sources of organs for transplantation. It notes several ambiguities and unresolved issues in the Pittsburgh protocol but concludes that neither the principle of double effect nor the distinction between killing and letting die (with the prohibition of the former and the allowance of the latter under some circumstances) erects insurmountable obstacles to the implementation of the protocol. Nevertheless, the requirement of the principle of double effect that the intended good effects outweigh the unintended side effects necessitates careful attention to the probable overall impact of the proposed policy on organ procurement, particularly because public mistrust plays such a significant role in limiting the number of organ donations.     

Perish and publish: non-heart-beating organ donation and unduly iterative ethical review

In the expanding repertoire of practices designed to increase the supply of organs for transplantation, non-heart-beating cadaver organ donation has generated an ongoing debate in the literature. The continuing stream of articles is disquieting in part because it documents a troubling "trial-and-error ethics" approach to the formulation of organ procurement policy, and because it raises serious questions about the reasons that the development of this policy is being mediated by published communication. In the light of concerns about the implicit support and credibility that professional publications give to organ procurement policies, restraint in publishing articles about non-heart-beating organ donation as well as in devising such policies is strongly advocated.     

The India Experience

This article featuring India constitutes one of five articles in a collection of essays on local capacity-building in research ethics by graduates from the University of Toronto’s Joint Centre for Bioethics MHSc in Bioethics, International Stream program funded by the Fogarty International Center for Advanced Study in the Health Sciences. Research ethics is a growing area of work and interest in India. Ethics review remains the weakest component in the mechanism of good clinical practice, and there is a severe dearth of professionals trained in ethics who can provide leadership. Although the Indian Good Clinical Practice Guidelines, the Indian Medical Council Act, and the Drugs and Cosmetics Act require that the Indian Council of Medical Research’s ethical guidelines be followed as a mandatory requirement for physicians who conduct research, there is a pervasive lack of awareness of basic requirements guiding the ethical conduct of research. There is a great need to strengthen India’s research ethics capacity and regulatory framework for research.     

Organ Procurement and Health Care Chaplaincy in Australia

As part of an Australian national project, quantitative data via a survey were retrospectively obtained from 327 Australian health care chaplains (staff and volunteer chaplains) to initially identify chaplaincy participation in various bioethical issues—including organ procurement. Over a third of surveyed staff chaplains (38%) and almost a fifth of volunteer chaplains (19.2%) indicted that they had, in some way, been involved in organ procurement issues with patients and/or their families. Nearly one-fifth of staff chaplains (19%) and 12% of volunteer chaplains had also assisted clinical staff concerning various organ procurement issues. One hundred of the surveyed chaplains volunteered to an interview. Qualitative data were subsequently coded from 42 of the chaplains who had been involved in organ procurement requests. These data were thematically coded using the World Health Organization ‘Pastoral Intervention Codings’ (WHO-PICs). The qualitative data revealed that through a variety of pastoral interventions a number of chaplains (the majority being staff chaplains) were engaged in the critical and sensitive issues of organ procurement. It is argued that while such involvement can help to ensure a holistic and ethically appropriate practice, it is suggested that chaplains could be better utilized not only in the organ procurement process but also for the training of other chaplains and clinicians.     

Neonatal Euthanasia Is Unsupportable: The Groningen Protocol Should Be Abandoned

The growing support for voluntary active euthanasia (VAE) is evident in the recently approved Dutch Law on Termination of Life on Request. Indeed, the debate over legalized VAE has increased in European countries, the United States, and many other nations over the last several years. The proponents of VAE argue that when a patient judges that the burdens of living outweigh the benefits, euthanasia can be justified. If some adults suffer to such an extent that VAE is justified, then one may conclude that some children suffer to this extent as well. In an attempt to alleviate the suffering of extremely ill neonates, the University Medical Center Groningen developed a protocol for neonatal euthanasia. In this article, I first present the ethical justifications for VAE and discuss how these arguments relate to euthanizing ill neonates. I then argue that, even if one accepts the justification for VAE in adults, neonatal euthanasia cannot be supported, primarily because physicians and parents can never accurately assess the suffering of children. I argue that without the testament of the patient herself as to the nature and magnitude of her suffering, physicians can never accurately weigh the benefits and burdens of a child’s life, and therefore any such system would condemn to death some children whose suffering is not unbearable. I conclude that because the primary duty of physicians is to never harm their patients, neonatal euthanasia cannot be supported.     

Ethical issues in research on preventing HIV infection among injecting drug users

The ethical issues in conducting research on preventing HIV infection are among the most complex of any area of human subjects research. This article is an update of a 1987 article that addressed potential conflicts between research design and ethics with respect to AIDS prevention among injecting drug users. The present article reviews current ethical issues that arise in the design and conduct of HIV/AIDS prevention research focused on injecting drug users. Disclaimer: The content of this publication is solely the responsibility of the authors and does not necessarily represent the views of the Beth Israel Medical Center or Johns Hopkins University.     

The dead donor rule: should we stretch it, bend it, or abandon it?

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.     

Ethics in an operations management course

Graduates of the management major at the University of Pittsburgh at Greensburg find employment in a variety of organizations. As future managers with employees from different professions, students expressed an interest in discussing ethics cases in the operations management class. The semester starts with students familiarizing themselves with various professional and corporate codes of ethics. Throughout the semester a number of short ethics’ cases in operations’ areas such as inventory management, scheduling, facility location, and product design are introduced to illustrate ethical issues that a manager and his/her employees might face. Students prepare individual responses before the in-class discussions. The semester ends with a long group ethics case discussion and formal case presentations. In the end-of-semester survey, students responded very favorably to an ethics component in the operations management class. An earlier version of this paper was presented at the Fourteenth Annual Meeting, Association for Practical and Professional Ethics, February 24–27, 2005.     

Presumed consent for organ preservation in uncontrolled donation after cardiac death in the United States: a public policy with serious consequences

Organ donation after cessation of circulation and respiration, both controlled and uncontrolled, has been proposed by the Institute of Medicine as a way to increase opportunities for organ procurement. Despite claims to the contrary, both forms of controlled and uncontrolled donation after cardiac death raise significant ethical and legal issues. Identified causes for concern include absence of agreement on criteria for the declaration of death, nonexistence of universal guidelines for duration before stopping resuscitation efforts and techniques, and assumption of presumed intent to donate for the purpose of initiating temporary organ-preservation interventions when no expressed consent to donate is present. From a legal point of view, not having scientifically valid criteria of cessation of circulation and respiration for declaring death could lead to a conclusion that organ procurement itself is the proximate cause of death. Although the revised Uniform Anatomical Gift Act of 2006 provides broad immunity to those involved in organ-procurement activities, courts have yet to provide an opinion on whether persons can be held liable for injuries arising from the determination of death itself. Preserving organs in uncontrolled donation after cardiac death requires the administration of life-support systems such as extracorporeal membrane oxygenation. These life-support systems can lead to return of signs of life that, in turn, have to be deliberately suppressed by the administration of pharmacological agents. Finally, allowing temporary organ-preservation interventions without expressed consent is inherently a violation of the principle of respect for a person's autonomy. Proponents of organ donation from uncontrolled donation after cardiac death, on the other hand, claim that these nonconsensual interventions enhance respect for autonomy by allowing people, through surrogate decision making, to execute their right to donate organs. However, the lack of transparency and the absence of protection of individual autonomy, for the sake of maximizing procurement opportunities, have placed the current organ-donation system of opting-in in great jeopardy. Equally as important, current policies enabling and enhancing organ procurement practices, pose challenges to the constitutional rights of individuals in a pluralistic society as these policies are founded on flawed medical standards for declaring death.     

Some Must Die

The transplantation and procurement of human organs has become almost routine in American society. Yet, organ transplantation raises difficult ethical and psychosocial issues in the context of “controlled” death, including the blurring of boundaries between life and death, self and other, healing and harming, and killing and letting die. These issues are explored in the context of the actual experiences of organ donors and recipients, brain death, the introduction of non‐heartbeating donor protocols, and the increasing reliance on living donors. The author draws on a thematic analysis of the way that organ transplantation is presented in the media, films, and science fiction and on his clinical experience as a psychiatrist working with transplant patients, their families, and the nurses and physicians who care for them.     

Polling and public policy

This commentary distinguishes five reasons why one might want to conduct a survey concerning people's beliefs about death and the permissibility of harvesting organs: (1) simply to learn what people know and want; (2) to determine if current law and practice conform to the wishes of the population; (3) to determine the level of popular support for or opposition to policy changes; (4) to ascertain the causes and effects of popular beliefs and attitudes; and (5) to provide guidance in determining which law and practices are ethical. The commentary expresses qualms about how well surveys in general can perform with respect to the fifth objective, and it provides specific reasons to doubt whether this survey is informative from the perspective of a moral philosopher concerned with the nature of death and the contours of a permissible system of organ procurement.     

Policy issues in a non-heart-beating donor protocol

The Pittsburgh protocol is ethically and legally acceptable as written, but more research is needed to determine if it can be implemented in ways that will observe the procedures that make it ethically acceptable. If so, its desirability as public policy will depend on the number of organs it is likely to generate and its effects on public attitudes toward organ donation generally. In the final analysis, the controversial aspects of this protocol concern symbolic issues about respect for the dead and near dead, rather than substantive concerns that real patient interests will be harmed.     

Debating ethical expertise

This paper explores the relevance of the debate about ethical expertise for the practice of clinical ethics. We present definitions, explain three theories of ethical expertise, and identify arguments that have been brought up to either support the concept of ethical expertise or call it into question. Finally, we discuss four theses: the debate is relevant for the practice of clinical ethics in that it (1) improves and specifies clinical ethicists' perception of their expertise; (2) contributes to improving the perception of moral competence of non-ethicists; (3) gives insight into complementary styles of argumentation of ethicists and non-ethicists; and (4) contributes to the awareness of the problem of profession-building of (clinical) ethicists.     

History of organ donation by patients with cardiac death

When successful solid organ transplantation was initiated almost 40 years ago, its current success rate was not anticipated. But continuous efforts were undertaken to overcome the two major obstacles to success: injury caused by interrupting nutrient supply to the organ and rejection of the implanted organ by normal host defense mechanisms. Solutions have resulted from technologic medical advances, but also from using organs from different sources. Each potential solution has raised ethical concerns and has variably resulted in societal acclaim, censure, and apathy. Transplant surgery is now well accepted, and the list of transplant candidates has grown far quicker than the availability of organs. More than 30,000 patients were awaiting organs for transplantation at the end of March 1993. While most organs came from donors declared dead by brain criteria, the increasing shortage of donated organs has prompted a reexamination of prior restrictions of donor groups. Recently, organ procurement from donors with cardiac death has been reintroduced in the United States. This practice has been mostly abandoned by the U.S. and some, though not all, other countries. Transplantation has been more successful using organs procured from heart-beating, "brain dead" cadavers than organs from non-heart-beating cadavers. However, recent advances have led to success rates with organs from non-heart-beating donors that may portend large increases in organ donation and procurement from this source.     

Not quite dead: why Egyptian doctors refuse the diagnosis of death by neurological criteria

Drawing on two years of ethnographic fieldwork in Egypt focused on organ transplantation, this paper examines the ways in which the “scientific” criteria of determining death in terms of brain function are contested by Egyptian doctors. Whereas in North American medical practice, the death of the “person” is associated with the cessation of brain function, in Egypt, any sign of biological life is evidence of the persistence, even if fleeting, of the soul. I argue that this difference does not exemplify an irresolvable culture clash but points to an unsettling aspect of cadaveric organ procurement that has emerged wherever organ transplantation is practiced. Further, I argue that a misdiagnosis of the problem, as one about “religious extremism” or a “civilizational clash,” has obfuscated unresolved concerns about fairness, access, and justice within Egyptian medical spheres. This misdiagnosis has led to the suspension of a cadaveric procurement program for over 30 years, despite Egypt’s pioneering efforts in kidney transplantation.