Defining the vital condition for organ donation

The issue of organ donation and of how the donor pool can or should be increased is one with significant practical, ethical and logistic implications. Here we comment on an article advocating a paradigm change in the so-called "dead donor rule". Such change would involve the societal and legal abandonment of the above rule and the introduction of mandated choice. In this commentary, we review some of the problems associated with the proposed changes as well as the problems associated with the current model. We emphasize the continuing problems with the definition of death and the physiological process of dying; we discuss the difficulties associated with a dichotomous view of death; we review the difficulties with non-beating heart donation and emphasize the current limitations of society's understanding of these complex issues. We conclude that public education remains the best approach and that such education should not be merely promotion of a particular ideology but honest debate of what is socially and morally acceptable and appropriate given the changes in vital organ support technology and the need to respect patient autonomy.     

Dying but not killing: donation after cardiac death donors and the recovery of vital organs

Michael Potts, Paul A. Byrne, and David W. Evans are critical of donation after cardiac death (DCD). Contrary to the authors' assertion that the removal of vital organs is the proximate cause of death, the eventual fulfillment of the neurological criteria of death is solely dependant on the rate of brain cell death in the absence of circulation. Consistent with the "dead donor rule," DCD is not the cause of death.There are also procedural mechanisms to address the potential conflicts of interest that concern the authors. Rather than being prohibited, DCD may be an ethically justifiable exception to the rule that organ donors must be dead prior to organ recovery.     

Donation after circulatory death: burying the dead donor rule

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.     

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.     

Clarifying the paradigm for the ethics of donation and transplantation: Was 'dead' really so clear before organ donation?

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.     

Abandon the dead donor rule or change the definition of death?

Research by Siminoff and colleagues reveals that many lay people in Ohio classify legally living persons in irreversible coma or persistent vegetative state (PVS) as dead that additional respondents, although classifying such patients as living, would be willing to procure organs from them. This paper analyzes possible implications of these findings for public policy. A majority would procure organs from those in irreversible coma or in PVS. Two strategies for legitimizing such procurement are suggested. One strategy would be to make exceptions to the dead donor rule permitting procurement from those in PVS or at least those who are in irreversible coma while continuing to classify them as living. Another strategy would be to further amend the definition of death to classify one or both groups as deceased, thus permitting procurement without violation of the dead donor rule. Permitting exceptions to the dead donor rule would require substantial changes in law--such as authorizing procuring surgeons to end the lives of patients by means of organ procurement--and would weaken societal prohibitions on killing. The paper suggests that it would be easier and less controversial to further amend the definition of death to classify those in irreversible coma and PVS as dead. Incorporation of a conscience clause to permit those whose religious or philosophical convictions support whole-brain or cardiac-based death pronouncement would avoid violating their beliefs while causing no more than minimal social problems. The paper questions whether those who would support an exception to the dead donor rule in these cases and those who would support a further amendment to the definition of death could reach agreement to adopt a public policy permitting organ procurement of those in irreversible coma or PVS when proper consent is obtained.     

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.     

The dead donor rule: how much does the public care...and how much should we care?

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 death" 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.     

移植协调员在DCD工作中的角色和作用

器官捐献是器官移植事业发展的基石,而协调员在器官捐献工作中则有着举足轻重的地位和作用。自2010年3月我国推行人体器官捐献试点工作以来,适合中国国情的DCD工作成为器官捐献工作的重中之重。如何充分发挥协调员在DCD工作中的作用,提高DCD捐献率和供体转化率,以有效地促进和推动DCD工作,是急待探讨和解决的问题。本文结合...     

The Ethics of Organ Donor Registration Policies: Nudges and Respect for Autonomy

Governments must determine the legal procedures by which their residents are registered, or can register, as organ donors. Provided that governments recognize that people have a right to determine what happens to their organs after they die, there are four feasible options to choose from: opt-in, opt-out, mandated active choice, and voluntary active choice. We investigate the ethics of these policies' use of nudges to affect organ donor registration rates. We argue that the use of nudges in this context is morally problematic. It is disrespectful of people's autonomy to take advantage of their cognitive biases since doing so involves bypassing, not engaging, their rational capacities. We conclude that while mandated active choice policies are not problem free—they are coercive, after all—voluntary active choice, opt-in, and opt-out policies are potentially less respectful of people's autonomy since their use of nudges could significantly affect people's decision making.     

Death, organ transplantation and medical practice

A series of papers in Philosophy, Ethics and Humanities in Medicine (PEHM) have recently disputed whether non-heart beating organ donors are alive and whether non-heart beating organ donation (NHBD) contravenes the dead donor rule. Several authors who argue that NHBD involves harvesting organs from live patients appeal to "strong irreversibility" (death beyond the reach of resuscitative efforts to restore life) as a necessary criterion that patients must meet before physicians can declare them to be dead. Sam Shemie, who defends our current practice of NHBD, holds that in fact physicians consider patients to be dead or not according to physician intention to resuscitate or not. We suggest that criteria for a concept are not necessarily truth conditions for assertions involving the concept. Hence, non-heart beating donors may be declared dead without meeting the criterion of strong irreversibility even though strong irreversibility is implied by the concept of death. Our perception that a concept applies in a given case is determined not by the concept itself but by our necessary skill and judgment when using it. In the case of deciding that a patient is dead, such judgment is learned by physicians as they learn the practice of medicine and may vary according to circumstances. Current practice of NHBD can therefore be defended without abandoning death as an empirical concept, as Shemie appears to do. We conclude that the dead donor rule continues to be viable and ought to be retained so as to guarantee what the public most cares about as regards organ donation: that physicians can be trusted to make determinations of eligibility for organ donation in the interests of patients and not for other purposes such as increasing the availability of organs.     

Harvesting the living?: separating "brain death" and organ transplantation

The chronic shortage of transplantable organs has reached critical proportions. In the wake of this crisis, some bioethicists have argued that there is sufficient public support to expand organ recovery through use of neocortical criteria of death or even pre-mortem organ retrieval. I present a typology of ways in which data gathered from the public can be misread or selectively used by bioethicists in service of an ideological or policy agenda, resulting in bad policy and bad ethics. Such risks should lead us to look at alternatives for increasing organ supplies short of expanding or abandoning the dead donor rule. The chronic problem of organ scarcity should prompt bioethicists to engage in constructive dialogue about the relation of the social sciences and bioethics, to examine the social malleability of the definition of death, and to revisit the question of the priority of organ transplants in the overall package of healthcare benefits provided to most, but not all, citizens.     

Ambivalence,Autonomy, and Organ Sales

Recent philosophical arguments in favor of legal markets in human organs such as kidneys claim that respect for autonomy justifies such markets. I argue that these arguments fail to establish the moral permissibility of commercialized organ sales because they do not show that those most likely to serve as vendors would choose to sell autonomously. Pro‐market views utilize hierarchical theories of autonomy to demonstrate that potential organ vendors may autonomously consent to selling their organs even in the absence of any practical alternative to doing so. But central to hierarchical accounts of autonomy is the idea that persons my experience volitional ambivalence, a condition in which the will is irreconcilably conflicted. Because commercialized organ sales would create volitional ambivalence in many of those who opt to sell an organ, the choice to sell an organ would not be an autonomous one.     

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.     

Death and organ procurement: public beliefs and attitudes

Although "brain death" and the dead donor rule--i.e., patients must not be killed by organ retrieval--have been clinically and legally accepted in the U.S. as prerequisites to organ removal, there is little data about public attitudes and beliefs concerning these matters. To examine the public attitudes and beliefs about the determination of death and its relationship to organ transplantation, 1351 Ohio residents >18 years were randomly selected and surveyed using random digit dialing (RDD) sample frames. The RDD telephone survey was conducted using computer-assisted telephone interviews. The survey instrument was developed from information provided by 12 focus groups and a pilot study of the questionnaire. Three scenarios based on hypothetical patients were presented: "brain dead," in a coma, or in a persistent vegetative state (PVS). Respondents provided personal assessments of whether the patient in each scenario was dead and their willingness to donate that patient's organs in these circumstances. More than 98 percent of respondents had heard of the term "brain death," but only one-third (33.7%) believed that someone who was "brain dead" was legally dead. The majority of respondents (86.2%) identified the "brain dead" patient in the first scenario as dead, 57.2 percent identified the patient in a coma as dead (Scenario 2), and 34.1 percent identified the patient in a PVS as dead (Scenario 3). Nearly one-third (33.5%) were willing to donate the organs of patients they classified as alive for at least one scenario, in seeming violation of the dead donor rule. Most respondents were not willing to violate the dead donor rule, although a substantial minority was. However, the majority of respondents were unaware, misinformed, or held beliefs there were not congruent with current definitions of "brain death." This study highlights the need for more public dialogue and education about "brain death" and organ donation.     

Intention to consent to living organ donation: an exploratory study

Living organ donation, that is the removal and transplantation of whole organs or segments of organs that a volunteering donor can live without, has been proposed as an effective and sustainable source of transplantable organs to mitigate the deficit in supply from the traditional cadaveric donor pool. In 2006, the Irish government deemed the development of a national Living Transplant Programme a service priority. The current study aimed to investigate the efficacy of the theory of planned behaviour (TPB) in the context of living organ donation intentions in an Irish sample. One hundred and thirty five undergraduate students (75 females, 60 males; mean age 20.6 years, SD 3.76) completed a self-report questionnaire assessing TPB variables while imagining themselves in a potential living liver donation scenario. In general, attitudes towards living donation were favourable. TPB components explained 44.8% of the variance in intentions. Attitude towards living donation emerged as the strongest predictor of intention. Self-reported levels of knowledge regarding living donation were generally poor. In light of recent EU Communications proposing the expansion of the use of living donors greater understanding of the determinants, psychological implications and ethical considerations in living donation decisions is necessary.     

The ethics of clinical innovation in psychopharmacology: Challenging traditional bioethics

Advance health care directives and informed consent remain the cornerstones of patients' right to self-determination regarding medical care and preferences at the end-of-life. However, the effectiveness and clinical applicability of advance health care directives to decision-making on the use of life support systems at the end-of-life is questionable. The Uniform Anatomical Gift Act (UAGA) has been revised in 2006 to permit the use of life support systems at or near death for the purpose of maximizing procurement opportunities of organs medically suitable for transplantation. Some states have enacted the Revised UAGA (2006) and a few of those have included amendments while attempting to preserve the uniformity of the revised Act. Other states have introduced the Revised UAGA (2006) for legislation and remaining states are likely to follow soon. The Revised UAGA (2006) poses challenges to the Patient Self Determination Act (PSDA) embodied in advance health care directives and individual expression about the use of life support systems at the end-of-life. The challenges are predicated on the UAGA revising the default choice to presumption of donation intent and the use of life support systems to ensure medical suitability of organs for transplantation. The default choice trumps the expressed intent in an individual's advance health care directive to withhold and/or withdraw life support systems at the end-of-life. The Revised UAGA (2006) overrides advance directives on utilitarian grounds, which is a serious ethical challenge to society. The subtle progression of the Revised UAGA (2006) towards the presumption about how to dispose of one's organs at death can pave the way for an affirmative "duty to donate". There are at least two steps required to resolve these challenges. First, physicians and hospitals must fulfill their responsibilities to educate patients on the new legislations and document their preferences about the use of life support systems for organ donation at the end-of-life. Second, a broad based societal discussion must be initiated to decide if the Revised UAGA (2006) infringes on the PSDA and the individual's right of autonomy. The discussion should also address other ethical concerns raised by the Revised UAGA (2006), including the moral stance on 1) the interpretation of the refusal of life support systems as not applicable to organ donation and 2) the disregarding of the diversity of cultural beliefs about end-of-life in a pluralistic society.     

Real Donors, Real Consent: Testing the Theory of Reasoned Action on Organ Donor Consent

In an attempt to apply the theory of reasoned action (TRA) to the process underlying organ donor consent, participants completed questionnaires concerning their affective responses to organ donation, as well as their intentions to donate. Participants were given the opportunity to sign an organ donor card. Those who chose to sign the card had more positive attitudes about donation, perceived donation as something that their reference group would encourage, and had stronger intentions to consent to signing a card. The current investigation extends the organ donor literature by using a true behavioral outcome measure indicating consent. Moreover, the pattern of results between attitudes, norms, intention, and behavior illustrates the usefulness of applying the TRA to yet another health-related behavior.