This article responds to the four pieces in this special symposium of the Journal of Law, Medicine & Ethics on uncontrolled organ donation following circulatory death . The response will focus on lessons and debates about the kinds of consent necessary and sufficient for temporary organ preservation in the context of DCD and for organ donation itself; on conflicts of obligation, loyalty, and interest in DCD and ways to address those conflicts; and on benefit, cost, risk assessments of uDCD programs, (...) including measures to achieve a more favorable balance of benefits, costs, and risks. (shrink)

The several articles in this special issue on organ donation after circulatory determination of death or, as it is often put, donation after cardiac death, draw lessons from different kinds of experience in order to guide efforts in the U.S. to develop or refine policies for DCD. One lesson comes from a major and, by many measures, successful experimental DCD program in Washington, D.C. in the 1990s. Another lesson comes from European countries that have adopted presumed-consent legislation, a form of (...) “opt out” that facilitates DCD as well as donation after neurological determination of death. Another lesson, from the perspective of critical care medicine in Canada, attends to the implications of viewing a dying patient, undergoing resuscitative procedures, as a potential organ donor. A final lesson sketches implications of legislation and court cases in the U.S., often involving DND, for initiating temporary organ preservation in DCD programs before consent has been obtained for organ donation. Some of these lessons are optimistic about the prospects for DCD, especially if certain steps are taken, while others are more cautious, particularly because of the costs and risks involved in DCD. (shrink)

The American Journal of Bioethics, Volume 11, Issue 8, Page 58-59, August 2011.

The current main source of transplantable organs is from heart-beating donors. These are patients who have suffered a catastrophic brain injury, been ventilated, declared dead by neurological criteria, and had their vital functions maintained mechanically until the point of transplantation. But the demand for organs far outstrips the supply, and these patients are not the only potential donors. The idea behind non-heart-beating transplantation is to expand the donor pool by including in it patients who are in hopeless conditions but who (...) are not dying because of brain injury and hence will not suffer the neurological death necessary to become heart-beating donors. As long as we continue to hold the so-called dead donor rule, according to which dying donors cannot have their organs taken before they are dead, this requires that death be able to be declared by alternative criteria, specifically by cardiopulmonary criteria. The challenge is to find such criteria that will identify a state that the public will readily recognize as death and that will facilitate non-heart-beating transplantation. a. (shrink)

Presumed consent alone will not solve the organ shortage, but it will create an ethical and legal context that supports organ donation, respects individuals who object to organ donation, relieves families from the burden of decision making, and can save lives.

In the early days of organ transplantation from deceased donors, the surgical team would bring the donor into the operating room with the recipient, the respirator would be stopped, and the team would wait for the donor’s heart to cease beating. This type of organ donation has been defined as donation after cardiac death, also referred to as non-heart-beating donation. These donors were not declared dead using neurological criteria, but rather using conventional cardiorespiratory criteria. In 1959, Mollaret and Goulon coined (...) the term “coma dépassé” for the patients with an irreversible state of coma and apnea. Jean Morelle and Guy Alexandre of the Catholic University of Louvain, Belgium, were the first to introduce a set of brain death criteria based on the description of coma dépassé, and carried out, in 1963, the first transplants from a brain dead donor in their country and in the world. (shrink)

The gap between the number of organs available for transplant and the number of individuals who need transplanted organs continues to increase. At the same time, thousands of transplantable organs are needlessly overlooked every year for the single reason that they come from individuals who were declared dead according to cardio pulmonary criteria. Expanding the donor population to individuals who die uncontrolled cardiac deaths will reduce this disparity, but only if organ preservation efforts are utilized. Concern about potential legal liability (...) for temporary preservation of organs pending a search for family members appears to be one of the impediments to wider use of donation in cases of uncontrolled cardiac death in states without statutes explicitly authorizing such action. However, we think that the risk of liability for organ preservation under these circumstances is de minimis, and that concerns about legal impediments to preservation should yield to the ethical imperative of undertaking it. (shrink)

In this paper, we assume that organ donation policy in the United States will continue to be based on an opt-in model, requiring express consent to donate, and that families will continue to have the prerogative to make donation decisions whenever the deceased person has not recorded his or her own preferences in advance. The limited question addressed here is what should be done when a potential donor dies unexpectedly, without any recorded expression of his or her wishes at hand, (...) while a family decision is being sought. (shrink)

The definition of death is one of the oldest and most enduring problems in biophilosophy and bioethics. Serious controversies over formally defining death began with the invention of the positive-pressure mechanical ventilator in the 1950s. For the first time, physicians could maintain ventilation and, hence, circulation on patients who had sustained what had been previously lethal brain damage. Prior to the development of mechanical ventilators, brain injuries severe enough to induce apnea quickly progressed to cardiac arrest from hypoxemia. Before the (...) 1950s, the loss of spontaneous breathing and heartbeat were perfect predictors of death because the functioning of the brain and of all other organs ceased rapidly and nearly simultaneously thereafter, producing a unitary death phenomenon. In the pretechnological era, physicians and philosophers did not have to consider whether a human being who had lost certain “vital functions” but had retained others was alive, because such cases were technically impossible. (shrink)

The distinction between the "permanent" (will not reverse) and "irreversible" (cannot reverse) cessation of functions is critical to understand the meaning of a determination of death using circulatory–respiratory tests. Physicians determining death test only for the permanent cessation of circulation and respiration because they know that irreversible cessation follows rapidly and inevitably once circulation no longer will restore itself spontaneously and will not be restored medically. Although most statutes of death stipulate irreversible cessation of circulatory and respiratory functions, the accepted (...) medical standard is their permanent cessation because permanence is a perfect surrogate indicator for irreversibility, and using it permits a more timely declaration. Therefore, patients properly declared dead in donation after circulatory death (DCD) protocols satisfy the requirements of death statutes and do not violate the dead donor rule. The acronym DCD should represent organ "donation after circulatory death" to clarify that the death standard is the permanent cessation of circulation, not heartbeat. Heart donation in DCD does not retroactively negate the donor's death determination because circulation has ceased permanently. (shrink)

The concept of whole‐brain death is under attack again. Scholars are arguing that the concept of brain death per se—regardless of the focus on “higher,” “stem” or “whole”—is fundamentally flawed. These scholars have identified what they believe are serious discrepancies between the definition and criterion of brain death, and have pointed out that medical professionals and lay persons remain confused about its meaning. Yet whole‐brain death remains the standard for determining death in much of the Western world and its defenders (...) believe this concept best maps onto our everyday conception of death. (shrink)

With so much attention being paid to the development and refinement of appropriate criteria and tests for death, little attention has been given to the broader conceptual issues having to do with its definition or with the relation of a definition to its criterion. The task of selecting the correct criterion is, however, virtually impossible without proper attention to the broader conceptual setting in which the definition operates as the key feature. All of the issues I will discuss arise because (...) of this lack of concern with conceptual matters. Such problems as incorrectly diagnosing a patient as dead prior to the harvesting of his or her organs, defending the idea that death is reversible, and advocating a brainstem criterion of death, are all, I believe, errors that derive from this misplaced emphasis. (shrink)

A recent commentary defends 1) the concept of 'brain arrest' to explain what brain death is, and 2) the concept that death occurs at 2–5 minutes after absent circulation. I suggest that both these claims are flawed. Brain arrest is said to threaten life, and lead to death by causing a secondary respiratory then cardiac arrest. It is further claimed that ventilation only interrupts this way that brain arrest leads to death. These statements imply that brain arrest is not death (...) itself. Brain death is a devastating state that leads to death when intensive care, which replaces some of the brain's vital functions such as breathing, is withdrawn and circulation stops resulting in irreversible loss of integration of the organism. Circulatory death is said to occur at 2–5 minutes after absent circulation because, in the context of DCD, the intent is to not attempt reversal of the absent circulation. No defense of this weak construal of irreversible loss of circulation is given. This means that paents in identical physiologic states are dead (in the DCD context) or alive (in the resuscitation context); the current state of death (at 2–5 minutes) is contingent on a future event (whether there will be resuscitation) suggesting backward causation; and the commonly used meaning of irreversible as 'not capable of being reversed' is abandoned. The literature supporting the claim that autoresuscitation does not occur in the context of no cardiopulmonary resuscitation is shown to be very limited. Several cases of autoresuscitation are summarized, suggesting that the claim that these cases are not applicable to the current debate may be premature. I suggest that brain dead and DCD donors are not dead; whether organs can be harvested before death from these patients whose prognosis is death should be debated urgently. (shrink)

Background Requirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations (OPOs) increasingly use the Internet for organ donation consent. Methods An analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services for informed consent. Content scores (...) were calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent. Results There were 60 Web sites for organ donation enrollment serving the 52 states. The median percent (10 percentile-90 percentile) content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33% (20–47), 79% (57–86), and 75% (50–100), respectively. The informed consent score was 0% (0–33). The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites (P < .05). The content scores for the four categories were similar among the 11 regions of the United Network for Organ Sharing. Conclusion The Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent. (shrink)

There are not enough solid organs available to meet the needs of patients with organ failure. Thousands of patients every year die on the waiting lists for transplantation. Yet there is one currently available, underutilized, potential source of organs. Many patients die in intensive care following withdrawal of life-sustaining treatment whose organs could be used to save the lives of others. At present the majority of these organs go to waste.In this paper we consider and evaluate a range of ways (...) to improve the number and quality of organs available from this group of patients. Changes to consent arrangements (for example conscription of organs after death) or changes to organ donation practice could dramatically increase the numbers of organs available, though they would conflict with currently accepted norms governing transplantation.We argue that one alternative, Organ Donation Euthanasia, would be a rational improvement over current practice regarding withdrawal of life support. It would give individuals the greatest chance of being able to help others with their organs after death. It would increase patient autonomy. It would reduce the chance of suffering during the dying process. We argue that patients should be given the choice of whether and how they would like to donate their organs in the event of withdrawal of life support in intensive care.Continuing current transplantation practice comes at the cost of death and prolonged organ failure. We should seriously consider all of the alternatives. (shrink)

The Pittsburgh protocol relies heavily on traditional moral distinctions, particularly the principle of double effect, to justify "managing" the dying process of a prospective organ donor in order to yield viable organs for transplantation. These traditional moral distinctions can be useful, particularly in casuistic or case-specific moral analysis, but their invocation here is unpersuasive, and potentially dangerous. The protocol relies on elaborate apologetics to avoid a candid confrontation with the moral challenge it poses—society's willingness to bring about the death of (...) one patient (in isolation and with potential discomfort) in order to benefit another patient. Not only will this protocol fail to solve the problem it purports to address, it threatens to undermine the delicate social accommodations by which we distinguish the living from the dead, permissible "allowings to die" from impermissible killings, and those from whom organs may be removed from those whose bodies must remain inviolate. (shrink)

The American Journal of Bioethics, Volume 11, Issue 8, Page 52-54, August 2011.

The current definition of death used for donation after cardiac death relies on a determination of the irreversible cessation of the cardiac function. Although this criterion can be compatible with transplantation of most organs, it is not compatible with heart transplantation since heart transplants by definition involve the resuscitation of the supposedly "irreversibly" stopped heart. Subsequently, the definition of "irreversible" has been altered so as to permit heart transplantation in some circumstances, but this is unsatisfactory. There are three available strategies (...) for solving this "irreversibility problem": altering the definition of death so as to rely on circulatory irreversibility, rather than cardiac; defining death strictly on the basis of brain death (either whole-brain or more pragmatically some higher brain criteria); or redefining death in traditional terms and simultaneously legalizing some limited instances of medical killing to procure viable hearts. The first two strategies are the most ethically justifiable and practical. (shrink)

Recent commentaries by Verheijde et al, Evans and Potts suggesting that donation after cardiac death practices routinely violate the dead donor rule are based on flawed presumptions. Cell biology, cardiopulmonary resuscitation, critical care life support technologies, donation and transplantation continue to inform concepts of life and death. The impact of oxygen deprivation to cells, organs and the brain is discussed in relation to death as a biological transition. In the face of advancing organ support and replacement technologies, the reversibility of (...) cardiac arrest is now purely related to the context in which it occurs, in association to the availability and application of support systems to maintain oxygenated circulation. The 'complete and irreversible' lexicon commonly used in death discussions and legal statutes are ambiguous, indefinable and should be replaced by accurate terms. Criticism of controlled DCD on the basis of violating the dead donor rule, where autoresuscitation has not been described beyond 2 minutes, in which life support is withdrawn and CPR is not provided, is not valid. However, any post mortem intervention that re-establishes brain blood flow should be prohibited. In comparison to traditional practice, organ donation has forced the clarification of the diagnostic criteria for death and improved the rigour of the determinations. (shrink)

The American Journal of Bioethics, Volume 11, Issue 8, Page W4-W6, August 2011.

Despite continuing controversies regarding the vital status of both brain-dead donors and individuals who undergo donation after circulatory death (DCD), respecting the dead donor rule (DDR) remains the standard moral framework for organ procurement. The DDR increases organ supply without jeopardizing trust in transplantation systems, reassuring society that donors will not experience harm during organ procurement. While the assumption that individuals cannot be harmed once they are dead is reasonable in the case of brain-dead protocols, we argue that the DDR (...) is not an acceptable strategy to protect donors from harm in DCD protocols. We propose a threefold alternative to justify organ procurement practices: (1) ensuring that donors are sufficiently protected from harm; (2) ensuring that they are respected through informed consent; and (3) ensuring that society is fully informed of the inherently debatable nature of any criterion to declare death. (shrink)

Legally defining “death” in terms of brain death unacceptably obscures a value judgment that not all reasonable people would accept. This is disingenuous, and it results in serious moral flaws in the medical practices surrounding organ donation. Public policy that relies on the whole-brain concept of death is therefore morally flawed and in need of revision.

Transplantation of vital organs has been premised ethically and legally on "the dead donor rule" (DDR)—the requirement that donors are determined to be dead before these organs are procured. Nevertheless, scholars have argued cogently that donors of vital organs, including those diagnosed as "brain dead" and those declared dead according to cardiopulmonary criteria, are not in fact dead at the time that vital organs are being procured. In this article, we challenge the normative rationale for the DDR by rejecting the (...) underlying premise that it is necessarily wrong for physicians to cause the death of patients and the claim that abandoning this rule would exploit vulnerable patients. We contend that it is ethical to procure vital organs from living patients sustained on life support prior to treatment withdrawal, provided that there is valid consent for both withdrawing treatment and organ donation. However, the conservatism of medical ethics and practical concerns make it doubtful that the DDR will be abandoned in the near future. This leaves the current practice of organ transplantation based on the "moral fiction" that donors are dead when vital organs are procured. (shrink)

Accepted medical practice already violates the dead donor rule. Explicitly jettisoning the rule—allowing vital organs to be extracted, under certain conditions, from living patients—is a radical change only at the conceptual level. But it would expand the pools of eligible organ donors.

Traditionally, organ retrieval from cadavers has taken place only in cases where the declaration of death has occurred using “brain death” criteria. Under these criteria, specific tests are performed to demonstrate directly a lack of brain activity. Recently, as a result of efforts to increase organ procurement, attention has been directed at the use of so-called “non-heart-beating” donors : individuals who are declared dead not as a result of direct measurements of brain function, but rather as a result of the (...) cessation of heart and respiratory functions. Attempts to obtain organs from such individuals have recently resulted in substantial negative publicity. Claims were made that the deaths of patients were being accelerated in order to get organs, and that sometimes organs were being removed from patients who were not yet dead. (shrink)

Traditionally, organ retrieval from cadavers has taken place only in cases where the declaration of death has occurred using “brain death” criteria. Under these criteria, specific tests are performed to demonstrate directly a lack of brain activity. Recently, as a result of efforts to increase organ procurement, attention has been directed at the use of so-called “non-heart-beating” donors : individuals who are declared dead not as a result of direct measurements of brain function, but rather as a result of the (...) cessation of heart and respiratory functions. Attempts to obtain organs from such individuals have recently resulted in substantial negative publicity. Claims were made that the deaths of patients were being accelerated in order to get organs, and that sometimes organs were being removed from patients who were not yet dead. (shrink)

The imbalance between supply of organs for transplantation and demand for them is widening. Although the current international drive to re-establish procurement via non-heart beating organ donation/donor is founded therefore on necessity, the process may constitute a desirable outcome for patient and family when progression to brain stem death does not occur and conventional organ retrieval from the beating heart donor is thereby prevented. The literature accounts of this practice, however, raise concerns that risk jeopardising professional and public confidence in (...) the broader transplant programme. This article focuses on these clinical, ethical, and legal issues in the context of other approaches aimed at increasing donor numbers. The feasibility of introducing such an initiative will hinge on the ability to reassure patients, families, attendant staff, professional bodies, the wider public, law enforcement agencies, and the media that practitioners are working within explicit guidelines which are both ethically and legally defensible. (shrink)

Donation after cardiac death protocols are widely accepted, so arguments for them have apparently been persuasive. But this does not mean they are sound.

“Brain death,” the determination of human death by showing the irreversible loss of all clinical functions of the brain, has become a worldwide practice. A biophilosophical account of brain death requires four sequential tasks: agreeing on the paradigm of death, a set of preconditions that frame the discussion; determining the definition of death by making explicit the consensual concept of death; determining the criterion of death that proves the definition has been fulfilled by being both necessary and sufficient for death; (...) and determining the tests of death for physicians to employ at the patient's bedside to demonstrate that the criterion of death has been fulfilled. The best definition of death is “the cessation of functioning of the organism as a whole.” The whole-brain criterion is the only criterion that is both necessary and sufficient for death. Brain death tests are used only in the unusual case in which a patient's ventilation is being supported. Brain death critics have identified weaknesses in its formulation. But despite its shortcomings, the whole-brain death formulation comprises a concept and public policy that make intuitive and practical sense and that has been well accepted by many societies. (shrink)

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.

The idea of passive euthanasia has recently been attacked in a particularly clear and explicit way by an “Ethics Task Force” established by the European Association of Palliative Care in February 2001. It claims that the expression “passive euthanasia” is a contradiction in terms and hence that there can be no such thing. This paper critically assesses the main arguments for the Task Force’s view. Three arguments are considered. Firstly, an argument based on the wrongness of euthanasia and the permissibility (...) of what is often called passive euthanasia. Secondly, the claim that passive euthanasia cannot really be euthanasia because it does not cause death. And finally, a consequence based argument which appeals to the bad consequences of accepting the category of passive euthanasia.We conclude that although healthcare professionals’ nervousness about the concept of passive euthanasia is understandable, there is really no reason to abandon the category provided that it is properly and narrowly understand and provided that “euthanasia reasons” for withdrawing or withholding life-prolonging treatment are carefully distinguished from other reasons. (shrink)

Expressing doubts about death criteria can serve healthy purposes, but can also cause a number of harms, including decreased organ donation rates and distress for donor families and health care staff. This paper explores the various causes of doubts about death criteria—including religious beliefs, misinformation, mistrust, and intellectual questions—and recommends responses to each of these. Some recommended responses are relatively simple and noncontroversial, such as providing accurate information. However, other responses would require significant changes to the way we currently do (...) business. Policymakers should establish minimum national standards for determining death to foster a trustworthy system; academics and publishers have a duty to publish only materials that substantially engage and advance the debate to minimize the harm caused by divided expert opinion; and opposition to the dead donor rule should be conceptually separated from doubts about death criteria. (shrink)

In this short article, we articulate a position that organ recovery from uncontrolled DCD — primarily patients who have suffered a cardiac arrest — is unlikely to result in a significant number of organs, and this small gain must be balanced against significant risk of unduly influencing resuscitation provider decision-making, and jeopardizing public trust in the propriety of organ donation and transplantation.