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The Dead Donor Rule.

Although living persons donate kidneys, cadaveric donors are the main source of solid organs for transplantation. Yet cadaveric donations have never been sufficient to meet the needs of persons with end-stage organ disease. One factor among many that limits the availability of cadaveric organs is the dead donor rule--the ethical and legal rule that requires that donors not be killed in order to obtain their organs.

Laws and norms against homicide forbid killings done for any purpose, including killings done to obtain organs to save the life of others. These laws and norms apply even if the person is unconscious, extremely debilitated, or very near death. The effect is to create the dead donor rule--the rule that states that organ retrieval itself cannot cause death. Removal of organs necessary for life prior to demise would violate the dead donor rule regardless of the condition or consent of the donor because removal of those organs would kill the donor. Removal of nonvital organs prior to death would not violate the rule, though it would implicate other laws and ethical norms.

Laws and norms against killing are most clearly applicable when the person killed has not consented to the killing. But they also apply when a person requests death, whether to avoid suffering or to provide organs for transplant. The dead donor rule would thus prevent a person from committing suicide in order to provide organs to his family or others. In the short run the rule is deontologic rather than utilitarian, for it prevents the killing of one person for organs that would save the three or more lives that can be saved by a single cadaveric donor.

The dead donor rule is a center piece of the social order's commitment to respect for persons and human life. It is also the ethical linchpin of a voluntary system of organ donation, and helps maintain public trust in the organ procurement system. Although it is possible that some changes in the dead donor rule could be adopted without a major reduction in protection of persons and public trust, changes in the rule should be measured by their effect on both those functions.

Several recent proposals to increase the supply of cadaveric organs would create exceptions to the dead donor rule to allow donation when the donor lacks an upper brain and will imminently die (anencephalic infants) or will be executed (death row prisoners).[1] These proposals do not challenge the rule's core function of protecting persons against unwanted demise. They do not, for example, propose a "survival lottery" in which persons are picked by chance to be killed to provide organs to several others.[2] Nor would they permit competent persons to choose suicide by organ retrieval in order to save others. Instead, they would modify the rule at the margins of human life.

Proposals to permit donation from anencephalic infants or condemned prisoners aim to maintain respect for the core values underlying the dead donor rule while concluding that the benefits of relaxing the rule in these marginal cases outweigh the loss in respect for life and trust in the transplant system that might result. In contrast, proposals to retrieve organs from non-heart-beating donors claim to respect the dead donor rule as such by permitting organ retrieval only after the donor has been pronounced dead on cardiopulmonary grounds. Ethical controversy arises there, however, because uncertainties in determining cardiopulmonary death create a risk that the donor will not be dead when organ retrieval occurs, but will die as a result of the retrieval itself.

A closely related question concerns whether it is ethically acceptable for physicians to implement proposals that violate the dead donor rule in these marginal cases. From the time of Hippocrates, codes of medical ethics have condemned killing by physicians. This tradition continues strongly today in medical, ethical, and legal opposition to active euthanasia, physician-assisted suicide, and the participation of physicians in capital punishment and torture.[3] If the dead donor rule is relaxed to facilitate organ procurement in these marginal cases, it will require a concomitant relaxation in prohibitions against physicians killing. Many persons would count such a change as an additional reason for opposing exceptions to the dead donor rule.

Respect Prior to Death for Incompetent Persons and Those Near Death

The dead donor rule limits only organ retrieval that causes death. It says nothing about situations in which organ retrieval itself would not cause death. Removing nonessential organs or tissue from incompetent persons on the basis of substituted consent--for example, retrieving kidneys from retarded individuals or from those in persistent vegetative states--would not violate the dead donor rule because organ or tissue retrieval in those cases would not cause death. Retrieval of nonessential organs would, however, implicate concerns about showing proper respect for the dignity and well-being of incompetent persons, for example, not treating them as mere means to the ends of others. Although it would not violate the dead donor rule, retrieval in such cases still could not occur unless applicable ethical and legal requirements for consent by the donor or family had been met.

Some persons have mistakenly viewed the dead donor rule as also prohibiting retrieval of nonessential organs from comatose or incompetent persons prior to their death because ordinarily such organs are removed only after death has occurred. The fact that organ and tissue retrieval usually occurs after death, however, does not mean that retrieval cannot occur before death if ethical and legal norms for what may be done to persons prior to their death are observed.

An example that nicely illustrates the distinction between the dead donor rule and rules for respecting incompetent persons would arise in a situation in which a family member, say the father, would like to donate a kidney to his daughter who suffers from end-stage kidney disease and who is not tolerating dialysis well. Medical examination shows that he has a serious heart condition that rules him out as a live donor. Soon after, he suffers a massive cardiac arrest that leaves him in a permanent coma in which he can be maintained indefinitely.[4] At this point, removal of a kidney from him for transplantation to his daughter would not violate the dead donor rule because it would not cause his death. Whether it is ethically and legally acceptable, however, would depend on whether removal is consistent with laws and norms for respecting the interests of incompetent persons. In this case, based on his prior expressed wishes to donate to his daughter and the absence of harm to him from the donation, a plausible claim can be made that removal of the kidney is ethically and legally acceptable. If this option were not acceptable to the family, they could request that he be treated as a non-heart-beating donor, that is, have life support stopped, and then retrieve his kidney after he has been pronounced dead.

Brain Death and the Dead Donor Rule

A key factor in observing the dead donor rule is the determination of death. The United States and most European countries now accept that death can be determined by tests that show irreversible cessation of circulatory and respiratory function or irreversible cessation of all functions of the entire brain.[5] The latter tests--tests for whole-brain death--are necessary when the irreversible cessation of cardiopulmonary functions in a mechanically assisted patient cannot be independently established.

Determining death by tests for total brain death does not contradict or violate the dead donor rule because whole-brain death ("permanent cessation of the clinical functions of the entire brain," including the brain stem) is the criterion that indicates that death ("the permanent cessation of critical functions of the organism as a whole") has occurred.[6]

Critics argue that brain death tests for death lead to violations of the dead donor rule because studies have shown the presence of residual spontaneous electroencephalographic activity in some brain dead patients.[7] But as James Bernat argues, the rudimentary and random elecroencephalographic activity found in these studies "represents merely the isolated physiologic activity of a few surviving neurons and does not represent the systematic integrating function of the kind necessary to achieve classification as a clinical function."[8] Thus the continued functioning of some neurons after declaration of whole-brain death does not mean that the person is still alive because such electric activity does not show that the critical integrative functions of life produced by the brain still exist. If they have otherwise suffered the permanent loss of all clinical functions of the brain (whole-brain death), such persons are dead and organs can be removed without violating the dead donor rule.

Although the needs of organ transplantation have driven the development of brain death, whole-brain criteria for death should not be viewed as a subterfuge for the judgment that brain-dead persons are in fact alive but because of severe mental impairment may be killed for their organs. Persons who argue that whole-brain death is not an indication that death of the individual has occurred must either disagree about what critical loss counts as death or what tests count as adequate evidence that such critical loss has occurred. Although some misunderstanding and confusion about brain death continues to exist, even among physicians and operating room nurses, it is now well settled that brain death determinations of death do not violate the dead donor rule, but rather provide an additional set of tests for determining whether death has occurred.[9]

Anencephalic Infants

One proposal to change the dead donor rule would allow the retrieval of vital organs from anencephalic infants before they have suffered whole-brain death. Because few children die in circumstances where brain death is pronounced, organs for pediatric transplant, where organ size is a crucial factor, are in very short supply. Faced with the shortage of pediatric hearts, one center tried unsuccessfully to transplant a heart from a baboon to an infant with hypoplastic heart disease.[10] Because of medical and ethical opposition to further use of xenografts, the center then proposed with parental consent to use organs from anencephalic newborns who had expired after treatment was withdrawn.[11] When it was found that viable organs could not be obtained from anencephalic infants after death, consideration turned to removing organs before brain stem activity had ceased.

Such an alternative, however, is blocked by the dead donor rule. Although anencephalics lack an upper brain, they do have brain stem function, and thus are legally alive under existing criteria and tests for whole-brain death. Removing hearts and livers from anencephalic infants prior to total brain death would thus violate the dead donor rule and could be punishable as homicide. If anencephalics were to be a viable source of organs for pediatric transplant, an exception to the dead donor rule would have to be enacted into law and incorporated into ethical norms.

An ethical argument in favor of relaxing the rule in the case of anencephaly can be made on the ground of beneficence to the potential recipients and the families who wish to donate and the absence of harm to the anencephalic donors. Because anencephalic infants have only a brain stem, they clearly lack consciousness or interests.[12] They will not survive for long, even with aggressive treatment, and there is no ethical or legal obligation to treat them aggressively--even to treat them at all.[13] Parents faced with this personal tragedy welcome the opportunity to donate organs, and may even initiate the request to take vital organs before brain stem activity has ceased. Many children desperately await transplantation. They and their families would greatly benefit by the organs that became available from anencephalic donors under the proposed exception. Because anencephalics are born without any upper brain, a narrow exception to the dead donor rule could be written without also extending the exception to persons in persistent vegetative states or other conditions of consciousness who were born with an upper brain and were once competent.[14]

Strong arguments also exist against recognizing an exception. A primary one is the need to keep a bright line against killing individuals who are alive. Opponents also cite the difficulties in diagnosing anencephaly and the corresponding risk of mistaken diagnoses, the small number of children who would benefit, and the risk that this exception would make it much more likely that additional exceptions to the dead donor rule would be enacted for those in persistent vegetative states or with severe, irreversible mental illnesses.[15] An exception might also reinforce public fears that the interests of organ donors would be sacrificed to obtain organs, and violate symbolic concerns for showing respect for human life by not killing. Finally, physicians would, in the very act of retrieving vital organs, be killing the anencephalic patient.

The arguments against recognizing an exception to the dead donor rule for anencephalic infants have carried the day. For example, the favorable 1992 opinion of the Council on Ethical and Judicial Affairs of the American Medical Association was withdrawn in the face of wide opposition and never reissued.[16] Nor have legislative proposals to permit such retrievals been enacted. In a 1991 case the Supreme Court of Florida refused to add "brain absent" as an exception to the brain dead or homicide laws despite the request of parents who wished to donate their infant's organs, noting that such a major change would have to come from the legislature not the courts.[17]

An additional factor conserving the dead donor rule in the case of anencephalic infants is the necessity for the government openly to authorize a change in the definition of death or in the law of homicide to allow killing by organ retrieval of anencephalic infants. Even if legal immunity from prosecution were provided, medical opposition to physicians removing organs that cause an anencephalic child's death might still continue. Indeed, transplant physicians might refuse to retrieve or use organs from anencephalics to prevent erosion of public trust in the organ donation and transplant system.

Although hearts and livers could not be taken from anencephalic children without a relaxation of the dead donor rule, parents could consent to have their anencephalic child serve as a living kidney or tissue donor without violating the dead donor rule.

Interestingly, however, few such uses have occurred, just as persons in persistent vegetative states have rarely been used as the source of nonessential organs and tissues, even though they would not be directly harmed by such use. Persons who oppose such use would likely argue that taking nonvital organs prior to death degrades or disrespects the anencephalic newborn or vegetative person because it so deliberately treats them as a means for the good of others.

Proponents would contest the accuracy of the claim that anencephalic or vegetative donors in such cases are degraded by being used as a source of organs or tissue for others on the ground that ethical concerns about using people as mere means do not apply to persons who due to absence of cortical function lack interests altogether. They might also argue that the situation offers them the opportunity, through proxy consent, to participate in the very human act of helping other humans to survive. Still, there has been little movement to use anencephalic newborns or vegetative patients as donors even in situations that would not violate the dead donor rule or otherwise directly harm the donors.

Organ Retrieval as a Form of Execution

With over 3,200 persons now awaiting execution in the United States and some forty to seventy-five prisoners executed each year, proposals to retrieve organs for transplant from capital punishment have surfaced in recent years.[18] The idea gained slight momentum in the early 1990s when a condemned prisoner in Georgia offered to donate organs as part of his execution and sued unsuccessfully for the opportunity.[19] Bills to permit organ retrievals from executions have been introduced in a few state legislatures (pp. 432-33).

In considering proposals to use the organs of condemned prisoners, we must distinguish procuring organs from executed prisoners after their death or during their lives from procuring organs from them as a form of execution. There is no ethical or legal objection to removing organs or tissue from executed bodies after death, if consent of the deceased or next of kin has been obtained. Although most methods of execution would render organs unacceptable for transplant, the unclaimed bodies of executed inmates are routinely given to medical schools for anatomical study.[20] Nor is there any ethical bar to a condemned prisoner serving as a living donor of a kidney or tissue, as long as the prisoner freely consents. Indeed, Texas and other capital punishment states permit live donations from condemned prisoners.[21]

The question of execution by organ retrieval is quite different. To avoid the damaging effects on organs from execution by lethal injection, electrocution, hanging, gas, or firing squad, organ retrieval itself would become the method of execution. The condemned prisoner would request this method five to seven days before the execution date.[22] At the time selected for execution, the prisoner would be taken from death row to the prison hospital and strapped on a gurney as in preparation for execution by lethal injection. Witnesses to the execution, including the victim's family, could view the insertion of intravenous lines and administration of anesthetic outside of the operating room. When the prisoner became unconscious, he would be moved to an operating room where the transplant team would then remove all his organs. When organ removal was completed, ventilatory or other mechanical assistance would be terminated, as occurs in retrieval from brain-dead, heart-beating cadavers. Death would be pronounced as having occurred either at the time that the heart and lungs were removed, or when mechanical assistance was terminated. The retrieved organs would then be distributed to consenting recipients in accordance with existing rules for distributing organs.

Such a procedure would clearly violate the dead donor rule. Retrieval

of vital organs itself would be the cause of death because once heart, lungs, and liver are removed one would soon have to turn off the heart-lung bypass machines that are sustaining function during removal of vital organs. Physicians retrieving organs would thus also be executing the prisoner. For such a procedure to be acceptable, an exception to the dead donor rule in the case of executions would have to be recognized.

The main argument for an exception in this case is that the prisoner will in any case be executed. An exception to the rule to permit a mode of execution that protects organs would not harm the prisoner or deprive him of continued life, and thus would not infringe or deny the core values underlying the dead donor rule. The state in any case will be executing the prisoner, and the exception would permit the state to kill another in a way that salvages his organs. In addition, an exception for execution by organ retrieval has the salutary effect of respecting and preserving the lives of recipients at the very moment that the condemned person's life is taken as punishment for his having previously taken the life of others.

Supporters of such an exception might require that several other conditions be met for execution by organ retrieval to be acceptable: Organ retrieval executions might be permitted only at the request of the condemned prisoner made at a specified time in advance of the execution. The permission of the victim's family might also be required. Potential recipients would be free to reject organs from this source. Most important, the inmate's request for execution by organ retrieval should not influence prior decisions about guilt and punishment, or later decisions for clemency.

For persons opposed to capital punishment, execution by organ retrieval is as objectionable as execution by other means. They may also doubt that the prospect of organ donation by execution would not influence the willingness to impose capital punishment at earlier stages of the process, or that condemned prisoners would voluntarily choose such an option. Persons who believe that capital punishment is morally and legally justified might also oppose such executions. They might fear that such a practice could weaken public acceptance of capital punishment by making executed criminals who donate look altruistic and thus deserving of a reprieve, or tainting all executions by associating them with allegations of Chinese practices of executing prisoners to obtain organs to sell on the international market. Finally, many persons would oppose execution by organ retrieval in order to maintain strict adherence to the dead donor rule and strict separation of doctors and killing.[23]

The opponents of execution by organ retrieval have prevailed, and are likely to prevail for some time to come. The great aversion to an exception to the dead donor rule in the case of lawful executions is not adequately explained by the values underlying the dead donor rule. If state employees may legally kill a condemned criminal by drug, gas, or more violent means, it should not matter that execution occurs by removal of vital organs. This would not constitute an unconstitutional "cruel or unusual" punishment because there is nothing crueler about this method of execution, chosen by the prisoner, than other methods.

A stronger ground for opposition is the role that transplant physicians and nurses would necessarily play in a system of execution by organ retrieval. Execution by organ retrieval could not be carried out by non-physician executioners as now occurs with execution by lethal injection and other methods. Even if some transplant doctors and nurses who accept the moral validity of capital punishment might be willing to participate in organ retrieval executions, their participation would violate medical ethical pronouncements against the participation of physicians in executions. The execution would also have to occur in the operating room of a hospital. If the prison hospital lacked adequate facilities, a hospital willing to allow organ retrieval executions on its premises would have to be found--and it is likely that few transplant teams or hospitals would be willing to participate.

Opposition to such an exception also arises from the need to keep the death penalty separate from other social institutions. The death penalty is highly problematic morally, legally, and socially in those states that allow it; it would become even more so if it also served as a method of organ procurement. Interjecting transplantation into the controversy over capital punishment could also taint public perceptions of the beneficence of transplantation. Members of the public might come to view organ procurement teams as "killers" who harvest organs before or after death. Such a perception could reduce the willingness of families to donate, and thus impair the prospects of persons awaiting transplants. The purpose and effect of capital punishment is to end the life of a person who has himself taken life. Trying at the same time to preserve other lives through execution by organ retrieval only confuses the situation. It is best for organ transplantation and capital punishment to go their separate ways.

Non-Heart-Beating Donors

Another proposal to increase the A supply of cadaveric organs for transplant focusing attention on the dead donor rule is the use of non-heart-beating cadavers as organ donors. The first cadaveric organ donors were persons declared dead on cardiopulmonary criteria, who either suffered cardiac arrest in the hospital or who arrived there dead.[24] With the acceptance of whole-brain criteria of death, organ procurement shifted to heart-beating cadaveric donors--those persons who were found to be brain-dead while cardiopulmonary functions were mechanically sustained. The shortage of brain-dead heart-beating donors has now refocused attention on the use of non-heart-beating donors (NHBDs).

The use of NHBDs that implicates the dead donor rule involves those cases that are planned or controlled, as opposed to those persons who are brought to the hospital dead. These protocols developed out of family requests to donate organs in situations in which it was unlikely that death would be pronounced on brain death grounds, thus preventing solid organ donation from occurring. Organ donation is a significant positive experience for those facing the death of a loved one; if these families are to have that positive experience, organ donation would have to occur immediately after death has been declared subsequent to withdrawal of life support--the non-heart-beating donor situation.

In controlled NHBD cases a family requests that treatment be withdrawn from a loved one who is terminally ill but not brain dead and that his or her organs then be donated for transplant. To minimize warm ischemic time damaging to organs, ventilatory assistance to the patient may be withdrawn in the operating room, where the family may choose to be present. After withdrawal of life support, the patient's attending physician, who is not part of the organ recovery team, determines whether the heart and respiration have stopped. The physician will then pronounce the patient dead or, to provide an additional margin of safety, in some cases will wait an additional two to five minutes after cardiac function has stopped before pronouncing death. At this point the physician and any family that is present would withdraw, and the transplant team, which has been prepped and waiting in an adjoining room, will enter and retrieve organs from the recently dead cadaver. Studies have shown that organs retrieved in this way suffer little damage and are viable for transplant.

Current interest in the use of controlled NHBDs arose from a 1992 protocol at the University of Pittsburgh Medical Center.[25] The protocol developed out of family requests, and intensivists, transplant physicians, nurses, and others developed a protocol responsive to identified concerns and presented it to the hospital's ethics committee. After approval by the ethics committee, the issues were examined at a bioethics conference in Pittsburgh and in scholarly publications.[26] Many in the transplant field see NHBDs as a key source to meet the growing demand for organs, and many other NHBD protocols have been proposed. Twenty-eight organ procurement organizations now have active NHBD programs, though many others do not.[27]

The ethical and legal questions raised by controlled NHBDs received national attention in April 1997 when a bioethicist charged that a proposal at the Cleveland Clinic to retrieve organs from NHBDs amounted to killing patients for their organs, and brought the protocol to the attention of the district attorney's office.[28] A 60 Minutes story on the Cleveland situation gave the impression that there were serious violations of the dead donor rule occurring at institutions that used NHBDs.

As a result of the growing controversy, Secretary of Health and Human Services Donna Shalala in 1997 requested that the Institute of Medicine (IOM) examine the medical, ethical, and legal aspects of NHBDs. In its final report, the IOM recommended much greater use of NHBDs, in accordance with publicly adopted protocols that followed guidelines it identified.[29] Its provision of a uniform protocol for the practice has now encouraged other programs to begin using NHBDs.

Ethical and legal controversy surrounds the use of controlled NHBDs because of the fear that retrieval of organs in the controlled setting could violate the dead donor rule,[30] in either of two ways. One was that the drugs administered prior to death in NHBD protocols--anticoagulants (heparin) and vasodilators (regitine) to minimize the effects of warm ischemia on organ viability--could hasten or even cause death.[31] This was a key issue in the Cleveland controversy.[32] Whether the drugs used in NHBD protocols cause or only hasten death, in either case the dead donor rule would have been violated. The doctrine of double effect would not shield an unintended death from these drugs from moral and legal disapproval because the intended benefit is for persons other than the patient.[33]

Transplant physicians with experience with these drugs deny that they are administered to hasten death or that they are given in such doses that they could have that effect, and the IOM found that administering heparin and regitine prior to death to preserve organs generally does not harm the donor and are justifiable as part of routine preparation for organ retrieval.[34] However, it noted that "in the occasional NHBD with ongoing intracranial bleeding or deficiencies in blood volume" the administration of such agents "is not indicated because it could actively cause death" (p. 52). Accordingly, it recommended "case-by-case decisions on the use of anticoagulants and vasodilators, and consideration of additional safeguards such as involvement of the patient's attending physician in prescribing decisions" (p. 52). Careful attention to whether such drugs need to be administered to the near-death patient to preserve organs and whether the dosages used are contraindicated because of the patient's condition should minimize the risk that efforts to preserve organs prior to death will inadvertently violate the dead donor rule.

A second way in which NHBD protocols are said to violate the dead donor rule is that they allow retrieval of organs before cessation of pulmonary function is irreversible. The risk is that death will be pronounced so quickly after the removal of life support and induction of cardiac arrest that the person will not have irreversibly lost cardiac function and thus will still be alive when organs are removed. That is, the person will appear to be dead, but might actually, if given longer time to breathe on his own or if immediately resuscitated, regain spontaneous respiration and circulation. If organ retrieval has already begun in such patients, retrieval will then be the cause of death, thus violating the dead donor rule.

To guard against such mistakes, NHBD programs have traditionally waited a few minutes after determining that cardiopulmonary function has ceased before pronouncing death and beginning organ retrieval. The IOM, for example, recommended a wait of at least five minutes together with electrocardiographic monitoring. NHBD programs in Pittsburgh and the University of Wisconsin wait two minutes. Yet some have argued that no additional wait after cardiac arrest should be required before pronouncing death because no additional wait is required for pronouncing death in the case of cardiac arrest in ICUs or other situations in which donation is not planned.[35]

Although very few studies have been done, no data suggest that autoresuscitation five minutes after cardiac arrest is a serious risk, and there is no reason to think that further studies would reveal a different result.[36] A more difficult problem concerns whether non-heart-beating donors pronounced dead after cardiac arrest and a two-to-five minute wait have irreversibly lost all cardiopulmonary function. The loss of function must be "irreversible" to satisfy the criteria for death under the laws of every state.

But who determines "irreversibility," and under what circumstances? Two understandings of irreversibility are relevant here. A strong understanding of the term would hold that patients who have suffered cardiac arrest have not irreversibly lost cardiac function and thus are not dead if they could have been resuscitated. Under this view of irreversibility NHBDs who are pronounced dead five minutes after cardiac arrest are not dead because persons have been resuscitated--restored to respiratory and cardiac function--for up to ten minutes after cardiac arrest.

A second view of irreversibility would hold that "a function is irreversibly lost if a morally defensible decision has been made not to reverse the loss" (p. 6). Because the patient had issued a prior directive against resuscitation or his family had lawfully requested a do not resuscitate order, no resuscitation after cardiac arrest would be morally and legally acceptable in situations of potential non-heart-beating donation. Therefore, the patient may legitimately be viewed as having irreversibly lost all cardiopulmonary function when death is pronounced on cardiopulmonary grounds.

Whether NHBD protocols observe or respect the dead donor rule thus will depend upon which meaning of the inherently ambiguous term "irreversible" one adopts. Given the strong protection now given to the right of patients and their families to reject resuscitation after cardiac arrest in situations very close to death, there is a very strong argument that the second construal of irreversible--whether a morally defensible decision against resuscitation has occurred--is the appropriate one in these cases. If so, NHBD protocols would involve no violation of the dead donor rule.

Because patients and their families have strong legal and moral rights to reject life support and resuscitation after cardiac arrest, it is difficult to see why one should adopt a construal of irreversibility that ignores whether the patient could in fact legally or morally be resuscitated. And because a severely debilitated patient with a do not resuscitate order who has suffered cardiac arrest after withdrawal of life support will not be resuscitated even if it were technically feasible to do so, there is no good reason why the stricter construal of irreversibility should be adopted over a construal of reversibility that focuses on whether resuscitation after cardiac arrest has ethically and legally been rejected.

A decisional view of irreversibility reflects commonsense views of death, for the person is not now breathing and never will again. Not to regard her then as dead because she might have been resuscitated in a situation in which she never will be resuscitated is counterintuitive to common understandings of death held by the general public, families, health care providers, and most ethicists, philosophers, and lawyers who study these issues.

Ethical and legal issues beyond the question of irreversibility also arise with NHBD protocols, but they do not implicate the dead donor rule. The practice of administering heparin or regitine prior to withdrawal of life support in order to minimize warm ischemic time in carefully selected cases does, however, raise the question whether administration of drugs not for the patient's benefit is respectful of the incompetent patient. This question should be resolved on the basis of whether the drugs harm the patient and whether the patient or the proxy have lawfully consented to them. If no harm is shown and there is lawful consent, the mere fact that something is being done to the patient not for his benefit would not in itself make administration of the drugs unlawful or unethical. A similar analysis would apply to cannulization of the patient prior to death so that cold perfusion to preserve organs after death has been pronounced can be administered rapidly. If the patient will not be harmed by the cannulization and there is proper consent, it is ethically acceptable prior to death.

The debate over the use of NHBDs shows that their use in accordance with guidelines such as those recommended by the IOM does comply with the dead donor rule. Unlike the case of anencephaly, where the donor is clearly alive under whole-brain criteria of death when vital organs are taken, the use of NHBDs involves: no violation of the dead donor rule and requires no public alteration or exception to it. Nevertheless, it is important that NHBDs are used only according to publicly announced protocols that contain clear procedures for minimizing the risk of any such violations. Such protocols should require that death is pronounced according to the attending physician's judgment without pressure from transplant personnel, that tests and waiting periods are used that are reasonably certain to correctly ascertain cardiopulmonary death, and that administration of anticoagulants or vasodilators does not occur in circumstances that might hasten death or harm patients.

Change and the Dead Donor Rule

The dead donor rule plays an important role in protecting persons and engendering trust in a voluntary system of organ donation. Any change in the rule to increase organ supply requires convincing evidence that more benefit than harm to persons and the transplant system would result from such a change. Even then, strong resistance to modifying the rule would exist based on the prudential and symbolic advantages of strict maintenance of a rule against death by organ retrieval.

It is thus no surprise that none of the proposals for explicit exceptions to the dead donor rule have been adopted. Removing vital organs from anencephalic infants requires public recognition that such lives are so diminished or lacking in value that they may be killed for their organs. Although these newborns will imminently die and will suffer no harm from retrieval of vital organs, the symbolic costs of relaxing the dead donor rule appear to be too great to be tolerated. Similarly, organ retrieval executions have little support, despite their attempt to wring some good from society's deliberate taking of life.

The use of NHBDs, on the other hand, is morally and legally acceptable because of their careful attempt to respect the dead donor rule. The debate over the use of NHBDs, however, illustrates the strong opposition that probably would exist if vital organs were taken from non-heart-beating donors who were not dead or if drugs administered to preserve organs also caused death. Despite the briefness and poor quality of the life remaining to such donors, violation of the dead donor rule would most likely be as strongly opposed here as it is with anencephalic infants.

The conservative posture that now exists toward maintaining the dead donor rule is likely to continue for some time, but not because of logical necessity. One could imagine that the question of how strictly the dead donor rule should be adhered to in order to maintain respect for persons and trust in the organ procurement system might be answered differently as medical, ethical, and social conditions and perceptions change. We might, for example, come to accept that persons who have only brain stem function or who are permanently unconsciousness are so close to being dead that we are willing to take their vital organs when clear benefits to others could be shown.[37] Opponents or proponents of capital punishment might come to accept the need to save lives even as executions occur, and support execution by organ retrieval. Only a slight shift in attitude would then be needed to view the transplant team's role in executions as life-affirming, just as it is in organ retrievals from brain-dead, heart-beating cadavers whose cardiopulmonary functions are ended by organ retrieval. Such shifts in the strictness of the dead donor rule could occur without impairing respect for human life generally or diluting perceptions of physicians as healers, because the life at stake in these cases is so marginal in quality or expectancy and the resulting preservation of life in recipients is so significant.

Yet it is highly unlikely that such changes in perception or practice will soon occur. The symbolic importance of the dead donor rule is so great that even the slightest explicit deviation from it confronts a very high presumption of unacceptability. An important factor in strictly maintaining the rule is the small number of lives that would be saved as a result. With roughly fifty executions and fifty anencephalic births occurring each year, and only a portion of these prisoners or families likely to opt for organ donation, relatively few lives would be saved at the price of crossing an important symbolic threshold. Of course, any additional contribution to the pool of donor organs is welcome. Each cadaveric donor made possible by changes in the dead donor rule could save or extend the lives of three or more existing individuals. But saving the lives of others, as the dead donor rule itself shows, has never been a uniformly privileged activity. Efforts to increase organ supply would be more fruitfully directed to increasing acceptance of NHBDs and the desirability of donating organs generally than to changing the dead donor rule.


The author is grateful to Mitchell Berman for helpful comments on an earlier draft.


[1.] American Medical Association, Council on Ethical and Judicial Affairs, "The Use of Anencephalic Infants as Organ Donors: A Critique," JAMA 273 (1995): 1614-18; Laura-Hill M. Patton, "A Call for Common Sense: Organ Donation and the Executed Prisoner," Virginia Journal of Social Policy & Law 3 (1996): 387-434; Stuart J. Youngner and Robert M. Arnold, "Ethical, Psychological, and Public Policy Implications of Procuring Organs from Non-Heart-Beating Donors,"JAMA 269 (1993): 2769-74.

[2.] John Harris, "Survival Lottery," Philosophy 50 (1995): 81-87.

[3.] William J. Curran and Ward Casscells, "The Ethics of Medical Participation in Capital Punishment by Intravenous Drug Injection," NEJM 302 (1980): 226-30; American Medical Association, Council on Ethical and Judicial Affairs, "Physician Participation in Capital Punishment," JAMA 270 (1993): 365-68; Robert D. Truog and Troyen A. Brennan, "Participation of Physicians in Capital Punishment," NEJM 329 (1993): 1346-50; American College of Physicians, Breach of Trust: Physician Participation in Executions in the United States (Philadelphia: American College of Physicians, 1994).

[4.] Stuart J. Youngner, personal communication.

[5.] President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Defining Death (Washington, D.C.: U.S. Government Printing Office, 1981); James L. Bernat, "A Defense of the Whole-Brain Concept of Death," Hastings Center Report 28, no. 2 (1998): 14-23.

[6.] Bernat, "A Defense," p. 17.

[7.] Amir Halevy and Baruch Brody, "Brain Death: Reconciling Defintions, Criteria, and Tests," Annals of lnternal Medicine 119 (1993): 519-25.

[8.] Bernat, "A Defense," p. 18.

[9.] Stuart J. Youngner, Martha Allen, Edward T. Bartlett et al., "Psychological and Ethical Implications of Organ Retrieval," NEJM 313 (1985): 321-23.

[10.] Arthur L. Caplan, "Is Xenografting Morally Wrong?" Transplant Proceedings 24 (1992): 722-27.

[11.] "Anencephalic Infants: A Source of Controversy" [Symposium], Hastings Center Report 18, no. 4 (1988): 5-34.

[12.] Medical Task Force on Anencephaly, "The Infant with Anencephaly," NEJM 322 (1990): 669-74.

[13.] Child Abuse Amendments of 1984, codified at 42 U.S.C.A. 5102, 5106, 5111-5113, 5115 (West Supp. 1998).

[14.] John A. Fletcher, Michael R. Harrison, and John A. Robertson, "Primates and Anencephalic Infants as Sources for Pediatric Organ Transplants," Fetal Therapy 1 (1996): 150-64.

[15.] D. Alan Shewmon, Alexander M. Capron, Warwick J. Peacock, Barbara L. Schulman, "The Use of Anencephalic Infants: A Critique," JAMA 261 (1989): 1773-81.

[16.] Diane M. Giannelli, "Ethics Council Reverses Stand on Anencephalic Organ Donors," American Medical News, 25 December 1995, p. 3.

[17.] In re T.A.C.P., 609 So.2d 588 (Fla. 1992).

[18.] George Lardner, "74 Executions This Year: The Most Since 1995," Seattle Times, 15 December 1997. Jack Kevorkian, the former pathologist who has challenged laws against assisted suicide, first proposed the idea in 1985. See Jack Kevorkian, "Medicine, Ethics, and Execution by Lethal Injection," Medicine & Law 4 (19850: 307-312.

[19.] Patton, "A Call for Common Sense."

[20.] Vernon's Ann. Texas Code Criminal Procedure Art. 43.25 (West, 1998).

[21.] "Condemned Man Is Hoping to Save the Lives of Others; He Seeks to Donate His Organs for Transplant after Execution," Dallas Morning News 25 October 1993.

[22.] Patton, "A Call for Common Sense."

[23.] Curran and Cascells, "The Ethics of Medical Participation in Capital Punishment"; American Medical Association, "Physician Participation in Capital Punishment"; Truog and Brenan, "Participation of Physicians in Capital Punishment"; American College of Physicians, Breach of Trust.

[24.] Institute of Medicine, Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement (Washington, D.C.: National Academy of Sciences, 1997), p. 20.

[25.] Institute of Medicine, Non-Heart-Beating Organ Transplantation; University of Pittsburgh Medical Center, "Policy for the Management of Terminally Ill Patients Who May Become Organ Donors after Death." 2 April 1992, Pittsburgh, Pennsylvania.

[26.] Conference on Ethical, Psychosocial, and Public Policy Implications of Recovering Organs from NHBCDs, 10 October 1992, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; "Non-Heart-Beating Donor Protocols to Increase Organ Donation" [Special Issue], Kennedy Institute of Ethics Journal 23 (1993): 1-262.

[27.] Institute of Medicine, Non-Heart-Beating Organ Transplantation.

[28.] Gina Kolata, "Controversy Erupts over Organ Removals," New York limes, 13 April 1997.

[29.] Institute of Medicine, Non-Heart-Beating Organ Transplantation.

[30.] Youngner and Arnold, "Ethical, Psychological, and Public Policy Implications"; Institute of Medicine, Non-Heart-Beating Organ Transplantation.

[31.] Institute of Medicine, Non-Heart-Beating Organ Transplantation; James F. Childress, "Non-Heart-Beating Donors of Organs: Are the Distinctions between Direct and Indirect Effects and between Killing and Letting Die Relevant and Helpful?" Kennedy Institute of Ethics Journal 3 (1993): 203-216.

[32.] Kolata, "Controversy Erupts."

[33.] Childress, "Non-Heart-Beating Donors of Organs," p. 211.

[34.] Institute of Medicine, Non-Heart-Beating Organ Transplantation, p. 52.

[35.] Stuart J. Youngner, Robert M. Arnold, Michael DeVita, "Issues in Determination of Death in Non-Heart-Beating Donor Protocols." Unpublished manuscript prepared for the Institute of Medicine Committee on Non-Heart-Beating Organ Donation.

[36.] Youngner, Arnold, DeVita, "Issues in Determination of Death."

[37.] Robert M. Veatch, "The Impending Collapse of the Whole-Brain Definition of Death," Hastings Center Report 23, no. 4 (1993): 18-24.

John A. Robertson, "The Dead Donor Rule," Hastings Center Report 29, no. 6 (1999): 6-14.

John A. Robertson holds the Vinson & Elkins chair at the University of Texas Law School, where he teaches criminal law, constitutional law, and law and bioethics. His most recent book is Children of Choice: Freedom and the New Reproductive Technologies (Princeton University Press, 1994).
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Publication:The Hastings Center Report
Date:Nov 1, 1999
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