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.

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)

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.

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. (shrink)

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.

The mainstream rationale for equating brain death (BD) with death is that the brain confers integrative unity upon the body, transforming it from a mere collection of organs and tissues to an organism as a whole. In support of this conclusion, the impressive list of the brains myriad integrative functions is often cited. Upon closer examination, and after operational definition of terms, however, one discovers that most integrative functions of the brain are actually not somatically integrating, and, conversely, most integrative (...) functions of the body are not brain-mediated. With respect to organism-level vitality, the brains role is more modulatory than constitutive, enhancing the quality and survival potential of a presupposedly living organism. Integrative unity of a complex organism is an inherently nonlocalizable, holistic feature involving the mutual interaction among all the parts, not a top-down coordination imposed by one part upon a passive multiplicity of other parts. Loss of somatic integrative unity is not a physiologically tenable rationale for equating BD with death of the organism as a whole. (shrink)

The University of Pittsburgh policy for procuring organs from non-heart-beating cadaver donors recognizes the potential for conflicts of interest between caring for a "hopelessly ill" patient who has forgone life-sustaining treatment and caring for a potential organ donor. The policy calls for a separation between those medical personnel who care for the gravely ill patient and those involved with the care of transplant recipients. While such a separation is possible in theory, it is difficult or impossible to attain in practice. (...) However, such a separation of duties would be unnecessary if an arbitrator were appointed to monitor the proceedings as they take place on a case-by-case basis. In this way, the biases—real or potential—of the individuals involved could be identified, and the harmful effects of the unavoidable conflicts of interest could be minimized. (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)

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)

The scarcity of vital organs has prompted several calls to either modify the dead donor rule or interpret it more broadly. Given its symbolic importance, however, the rule should be changed only cautiously.

The scarcity of vital organs has prompted several calls to either modify the dead donor rule or interpret it more broadly. Given its symbolic importance, however, the rule should be changed only cautiously.

Given the widening gap between the number of individuals on transplant waiting lists and the availability of donated organs, as well as the recent plateau in donations based on neurological criteria, there has been a growing interest in expanding donation after circulatory determination of death. While the prevalence of this form of organ donation continues to increase, many thorny ethical issues remain, often creating moral distress in both clinicians and families. In this article, we address one of these issues, namely, (...) the challenges surrounding patient and surrogate informed consent for donation after circulatory determination of death. First we discuss several general concerns regarding consent related to this form of organ donation, and then we address additional issues that are unique to three different patient categories: adult patients with medical decision-making capacity or potential capacity, adult patients who lack capacity, and pediatric patients. (shrink)

The “standard position” on organ donation is that the donor must be dead in order for vital organs to be removed, a position with which we agree. Recently, Robert Truog and Walter Robinson have argued that brain death is not death, and even though “brain dead” patients are not dead, it is morally acceptable to remove vital organs from those patients. We accept and defend their claim that brain death is not death, and we argue against both the US “whole (...) brain” criterion and the UK “brain stem” criterion. Then we answer their arguments in favour of removing vital organs from “brain dead” and other classes of comatose patients. We dispute their claim that the removal of vital organs is morally equivalent to “letting nature take its course”, arguing that, unlike “allowing to die”, it is the removal of vital organs that kills the patient, not his or her disease or injury. Then, we argue that removing vital organs from living patients is immoral and contrary to the nature of medical practice. Finally, we offer practical suggestions for changing public policy on organ transplantation. (shrink)

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.

The dead donor rule states that organ donors must be declared dead before any vital organs are removed. Recently, scholars and physicians have argued for the abandonment of the dead donor rule, based on the rule’s supposed connection with the concept of brain death, which they view as a conceptually unreliable definition of death. In this essay, I distinguish between methods of death determination and the question of whether or not the dead donor rule should be a guiding principle of (...) organ transplant ethics. In principle, the dead donor rule does not rely on any one definition of death, but only prohibits the taking of vital organs before a patient is declared dead. In light of this distinction, I argue that even if the dead donor rule is tied to brain death in practice, conceptual disagreement about brain death does not provide grounds for rejection of this rule. I then present evidence in support of the consistency and reliability of the diagnosis of brain death. I show that, when performed carefully and under specific clinical circumstances, the diagnosis of brain death is considered by most neurologists to be reliable. Finally, I argue that, without the dead donor rule, organ transplantation programs would become susceptible to violations of the ethical principle of respect for persons. (shrink)

The modern practice of organ donation after cardiocirculatory death (DCD) emerged in the 1990s as a response to the alarmingly wide gap between the number of transplantable organs available through organ donation after neurological death and the urgent organ transplantation needs of persons in end-organ failure. Various important ethical dimensions of DCD have been considered and debated by prominent organ donation/transplantation theorists and clinicians.In this article, consideration of some of these ethical elements provides a foundation for a proposed set of (...) ethically informed, pragmatic conditions that could assist in the development of health policies to guide the practice of organ donation after cardiocirculatory death. (shrink)

Many believe that the ethical problems of donation after cardiocirculatory death (DCD) have been "worked out" and that it is unclear why DCD should be resisted. In this paper we will argue that DCD donors may not yet be dead, and therefore that organ donation during DCD may violate the dead donor rule. We first present a description of the process of DCD and the standard ethical rationale for the practice. We then present our concerns with DCD, including the following: (...) irreversibility of absent circulation has not occurred and the many attempts to claim it has have all failed; conflicts of interest at all steps in the DCD process, including the decision to withdraw life support before DCD, are simply unavoidable; potentially harmful premortem interventions to preserve organ utility are not justifiable, even with the help of the principle of double effect; claims that DCD conforms with the intent of the law and current accepted medical standards are misleading and inaccurate; and consensus statements by respected medical groups do not change these arguments due to their low quality including being plagued by conflict of interest. Moreover, some arguments in favor of DCD, while likely true, are "straw-man arguments," such as the great benefit of organ donation. The truth is that honesty and trustworthiness require that we face these problems instead of avoiding them. We believe that DCD is not ethically allowable because it abandons the dead donor rule, has unavoidable conflicts of interests, and implements premortem interventions which can hasten death. These important points have not been, but need to be fully disclosed to the public and incorporated into fully informed consent. These are tall orders, and require open public debate. Until this debate occurs, we call for a moratorium on the practice of DCD. (shrink)

The emergence of controlled, Maastricht Category III, non-heart-beating organ donation programs has the potential to greatly increase the supply of donor solid organs by increasing the number of potential donors. Category III donation involves unconscious and dying intensive care patients whose organs become available for transplant after life-sustaining treatments are withdrawn, usually on grounds of futility. The shortfall in organs from heart-beating organ donation following brain death has prompted a surge of interest in NHBD. In a recent editorial, the British (...) Medical Journal described NHBD as representing “a challenge which the medical profession has to take up.”. (shrink)

While procurement of organs from donors who are not "brain dead" does not appear to pose insurmountable moral obstacles, the social practice may raise questions of conflict of interest. Non-heart-beating organ donation opens the door for pressure on patients or families to forgo possibly beneficial treatment to provide organs to save others. The combined effects of non-heart-beating donation and organ shortages at major transplant centers brought about by the 1991 United Network for Organ Sharing (UNOS) local-use organ allocation policy created (...) potential conflicts, including the fact that candidates for organs become potential donors far more frequently than previously. Hospitals with a major emphasis on transplantation have economic and academic interests that may have been hurt by the relative organ shortage. Some may view non-heart-beating organ donation as a way to restore weakened programs and thus unconsciously compromise recognition of problems associated with non-heart-beating donation. (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.

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)

The dead donor rule (DDR) originally stated that organ donors must not be killed by and for organ donation. Scholars later added the requirement that vital organs should not be procured before death. Some now argue that the DDR is breached in donation after circulatory determination of death (DCDD) programs. DCDD programs do not breach the original version of the DDR because vital organs are procured only after circulation has ceased permanently as a consequence of withdrawal of life-sustaining therapy. We (...) hold that the original rendition of the DDR banning killing by and for organ donation is the fundamental norm that should be maintained in transplantation ethics. We propose separating the DDR from two other fundamental normative rules: the duties to prevent harm and to obtain informed consent. (shrink)

The non-heart-beating cadaver donor procurement process might come in conflict with the organ sharing system by diverting organs from potential recipients. It might also have a negative effect on public attitudes about transplantation. The process could start society down a slippery slope leading to extending donor criteria. Some of these scenarios are merely theoretical, but the procedure should be monitored to avoid such problems.

A combination of emerging life support technologies and entrenched organ donation practices are complicating the physician's task of determining death. On the one hand, technologies that support or replace ventilation and circulation may render the diagnosis of death ambiguous. On the other, transplantation of vital organs requires timely and accurate declaration of death of the donor to keep the organs as healthy as possible. These two factors have led to disagreements among physicians and scholars on the precise moment of death. (...) In this article, I suggest that the debate about exactly when a person dies can benefit from distinguishing the strict biological concept of death from the medical standards for determining human death, and I show how an appreciation of the difference between the permanent and irreversible cessation of circulation is helpful in understanding the reasons for the two approaches to determining when death should be declared. (shrink)

Despite the popularity, success, and growth of programs of organ donation after the circulatory determination of death (DCDD), a long‐standing controversy persists over whether the organ donor is truly dead at the moment physicians declare death, usually following five minutes of circulatory and respiratory arrest. Advocates of the prevailing death determination standard claim that the donor is dead when declared because of permanent cessation of respiration and circulation. Critics of this standard argue that while the cessation of respiration and circulation (...) may be permanent, it may not be irreversible at the moment death is declared because, if cardiopulmonary resuscitation were performed, it might succeed. And because irreversibility of cessation of respiration and circulation is required by both the statute and the biological concept of death, the donor must be alive. Who is correct?Making two related distinctions clarifies the cause of the disagreement over whether the DCDD donor is dead and points to a possible resolution. First, in a determination of death, there is an important distinction between the permanent and the irreversible cessation of circulation and respiration—two associated phenomena that are often confounded. Second, there is an important distinction between the medical practice standard for death determination, in which physicians certify the permanent cessation of vital functions as sufficient for death declaration, and the underlying biological concept of death that requires the irreversible cessation of vital functions because death, by definition, is an irreversible event. (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 (NHBOD) is founded therefore on necessity, the process may constitute a desirable outcome for patient and family when progression to brain stem death (BSD) 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)

The fundamental determinant of death in donation after circulatory determination of death is the cessation of brain circulation and function. We therefore propose the term donation after brain circulation determination of death [DBCDD]. In DBCDD, death is determined when the cessation of circulatory function is permanent but before it is irreversible, consistent with medical standards of death determination outside the context of organ donation. Safeguards to prevent error include that: 1] the possibility of auto-resuscitation has elapsed; 2] no brain circulation (...) may resume after the determination of death; 3] complete circulatory cessation is verified; and 4] the cessation of brain function is permanent and complete. Death should be determined by the confirmation of the cessation of systemic circulation; the use of brain death tests is invalid and unnecessary. Because this concept differs from current standards, consensus should be sought among stakeholders. The patient or surrogate should provide informed consent for organ donation by understanding the basis of the declaration of death. In cases of circulatory cessation, such as occurs in DBCDD, death can be defined as the permanent cessation of brain functions, determined by the permanent cessation of brain circulation. (shrink)

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)