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This insight has an important implication for the neurologic literature on brain death. Literally hundreds of articles have attempted to establish the usefulness of ancillary tests to confirm or rule out the diagnosis of brain death ( 18, 27). However, in the absence of a gold standard about what constitutes brain death, we do not know what condition or state these ancillary tests are designed to confirm. Are they seeking to confirm 1) the complete absence of brain function, 2) a uniformly fatal prognosis, 3) the absence of consciousness, or 4) something else? Indeed, the lack of clarity on this point raises the question of whether this entire literature on confirmatory testing for brain death is incoherent.

The status of brain death is, in this sense, not dissimilar from the status of "legally blind." Both represent a point on a continuum of organ dysfunction (of the brain and of the eyes, respectively). By social convention, however, both signify a threshold with important medical, legal, and social implications. Patients who are legally blind are treated as if they are blind (even if they retain some rudimentary sight), and patients who are brain dead are treated as if they are dead (even if they retain some neurologic functioning and other characteristics of the living).

Most of the arguments advanced above have been articulated by others over the past several decades and, to our knowledge, have never been successfully refuted ( 12, 13, 28-32). Although they have not seriously undermined acceptance of the concept of brain death, this acceptance has nevertheless been described as representing only a "superficial and fragile consensus" ( 33). Indeed, some have worried that open discussion of this critique could jeopardize the important and successful program of organ procurement and transplantation, especially given the prominent role that the dead-donor rule has played in regulating the ethics of this practice ( 34). Such might be the case if we concluded on the basis of this critique that our practices of organ donation have been ethically flawed and that the incoherence of the concept of brain death means that our practices must be reconsidered or even suspended. We would emphatically argue, however, that this is not the case and that our approach to organ procurement is entirely ethical-but for reasons that are radically different from those that are traditionally given.

The foundations of the ethics of the organ transplantation are the twin principles of respect for persons and nonmaleficence (the duty not to harm, or primum non nocere). As presently understood, respect for persons is operationalized through obtaining informed consent, and the duty not to harm is honored through the dead-donor rule. The concept of brain death was explicitly developed so that organs could be removed from heart-beating donors without violating the dead-donor rule.

As an alternative, we propose that sometimes the harm of dying is sufficiently small that patients should be allowed to voluntarily accept that harm if it makes organ donation possible. Using this approach, organ donation could occur in full accord with the principles of respect for persons and nonmaleficence, but without reliance on the dead-donor rule. We believe this is a more straightforward approach, because it focuses directly on the questions of harm and consent rather than focusing on the indirect question of whether a patient is dead.

Under what circumstances might the harm of dying be sufficiently small that patients could be allowed to accept this harm to donate organs? Clearly, some threshold must be set. No healthy person should be allowed to make a suicidal donation of vital organs, even if such a person were fully competent and highly motivated to save the life of a loved one. Even less extreme donations should not be permitted, such as donation of a kidney from an individual with only one kidney, even if that individual willingly accepted the consequence of chronic hemodialysis.

Nevertheless, in some circumstances we believe that the harm of dying is sufficiently small that patients or surrogates should be allowed to voluntarily accept it to be able to donate organs. For example, some might say that if they were ever diagnosed as being permanently unconscious they would accept the harm of dying if this would make it possible for them to donate their organs to others. Similarly, some patients who are imminently dying might be willing to have their life shortened by a few minutes or hours if this would make organ donation possible. Society would have to determine, through the process of public deliberation and legislation, whether "permanent unconsciousness" and "imminently dying" define thresholds sufficiently low that patients should be allowed to accept the harm of dying to make it possible for them to donate organs.

Even if society made such donations legal, this approach would respect the fact that not all patients or surrogates would choose to donate under these circumstances. These patients and surrogates would be fully empowered to refuse, just as our current system respects the rights of brain-dead patients and their surrogates to refuse to donate. But it also recognizes that many would see the opportunity to donate vital organs as an important benefit when either continued life in a state of unconsciousness or only a brief postponement of death is not deemed to be of commensurate value.

At a practical level, the clinical states of "permanently unconscious" and "imminently dying" would need to be specifically defined. The Multi-Society Task Force on PVS (persistent vegetative state) defined diagnostic criteria for persistent and permanent vegetative state and articulated several lines of evidence in support of the claim that these patients are unconscious. These have been challenged, however, by reports of a few patients who seem to have fulfilled the criteria of the Task Force yet who have regained some degree of consciousness ( 35). Similarly, although anencephalic infants are also widely perceived as permanently unconscious, some have argued that even the rudimentary brainstem present in anencephalic infants may be capable of a minimal degree of consciousness ( 36). This is in contrast to patients who meet diagnostic criteria for brain death, in which there has never been a report of recovery of consciousness and in which there is less controversy about whether these patients have any capacity for consciousness ( 18).

Although our view would be that patients who meet brain death criteria should therefore be considered to be permanently unconscious and allowed to donate vital organs, we are silent on whether this opportunity to donate should be extended to patients in the permanent vegetative state or newborns with anencephaly. Given the controversy, perhaps it would be prudent to use the more conservative standard defined by brain death criteria until medical research can provide greater certainty about the capacity for consciousness in patients with these conditions.

The category of "imminently dying" would also need to be defined for practical use. Here again, prudence would recommend a conservative approach, limiting this category to those patients completely dependent on life support, in whom death would be expected within minutes of withdrawal of that support, and in whom no treatment alternatives are available or desired. This category would therefore include, for example, patients with cervical quadriplegia who desired withdrawal of mechanical ventilation or patients on cardiac support devices who refused continuation of that support or other treatment alternatives. These are similar to the standards that are currently used to identify candidates for non-heart-beating organ donation. Patients in this category would more often be able to make the decision about donation themselves, removing any concerns about the legitimacy of surrogate decision making in cases like this.

The principle of respect for persons also requires recognition that patients and families are not the only moral agents with a stake in this process. Both society and the medical profession have legitimate claims in determining who will be allowed to be an organ donor. Clearly, patients who are otherwise healthy cannot be allowed to become organ donors as a means to committing suicide. For this reason, we have narrowly defined the categories of patients who may be organ donors. Both medical professionals and society should refuse to allow donation from patients who do not fall into one of these categories. In particular, our proposal would recognize a large gap between the category of patients permitted to have withdrawal of life support and the category of patients permitted to donate organs. American law gives patients the virtually unlimited right to refuse medical treatments, regardless of their clinical condition. Therefore, many patients would have the right to die through refusal of life-sustaining treatment while not being in a category that would permit the option of organ donation.

Proposals similar to ours have been suggested by others over the years ( 37-41). All involve shifting the key ethical question from "Is the patient dead?" to "Are the harms of removing life-sustaining organs sufficiently small that patients or surrogates should be allowed to consent to donation?" Although this change would have many important consequences, it would not cast doubt on the ethics of current practices of organ procurement from patients who meet brain death criteria. These practices are clearly ethical-not because the patients are dead, but rather because they have been rendered permanently unconscious from an overwhelming brain injury.

Recognizing that the central ethical commitments of organ donation are respect for persons and nonmaleficence would bring greater clarity and consistency to many facets of the organ procurement enterprise. A single ethical standard could then be applied to both "living" donations and to what we currently regard as cadaveric donations ( 42). When a living individual wants to donate a kidney to a relative, it is ethically necessary, but not sufficient, for them to give their consent. These patients undergo a thorough evaluation, and if it is determined that making the donation would put the donor at substantial risk (such as if the potential donor was at high risk from anesthesia), he or she is not allowed to donate. In these situations, the principle of nonmaleficence is given greater weight than the individual's autonomous right to take risks on behalf of another. Just as we now determine when the risk of harm is too great to permit living donations, under our proposal we would decide the conditions (in terms of imminence of death or degree of neurologic impairment) when the risk of harm would be minimal enough to justify allowing the donation of life-sustaining organs.

Non-heart-beating organ donation is another practice that has been muddled by the dead-donor rule. These protocols have been rapidly gaining in popularity, especially after their qualified endorsement by the Institute of Medicine ( 43, 44). As with our proposal, protocols for non-heart-beating organ donation address not only patients who are neurologically devastated but also those who are imminently dying. Because patients eligible for these protocols are dependent on life support but not brain dead, they are unable to donate life-sustaining organs. To comply with the dead-donor rule, therefore, these patients must undergo an orchestrated withdrawal of life support, often in the operating room, with the swift removal of the transplantable organs within 2-5 mins of the patient's cardiac arrest (depending on the protocol).

The orchestrated death in these protocols would be unnecessary if, in abandoning the dead-donor rule, we asked whether the patient is sufficiently close to death or sufficiently neurologically impaired to justify their being a candidate for the protocol. If the answer to this question is yes, then one must ask whether it makes any sense to "make them dead" before the removal of their organs, especially because hearts and lungs are often not viable after the patient has had a cardiac arrest and because even other organs may be jeopardized by the ischemic time that is unavoidable in these protocols. Again, if the patient's condition is such that the procurement of life-sustaining organs can be seen as a justifiable goal in itself, then why not-at the request of the patient or surrogate-remove the organs in the operating room under anesthesia and optimize both the number and the viability of the organs obtained?

Our proposal offers important safeguards not found in non-heart-beating organ donor protocols. The typical candidate for non-heart-beating organ donor is a patient who has severe brain injury and is ventilator dependent. Even though the justification for withdrawal of the ventilator in this case is usually the brain injury, the severity of brain injury that is necessary to be a candidate for the protocol is completely undefined. All that is necessary is that the patient be expected to expire quickly from respiratory failure after the withdrawal of mechanical ventilation. This respiratory failure could be due to the brain injury, to pulmonary injury, or to a combination of the two. Although we do not doubt that patients who donate organs through non-heart-beating organ donor protocols generally have severe brain injury, the criteria that would be used in our proposal have the advantage of specifying the degree of brain injury that is necessary to be a candidate for organ donation.

Here's more (the references and tables are available from the source)

Recent debates in the United States and abroad have also suffered from emphasis on the dead-donor rule in thinking about the ethics of organ procurement. Several years ago, the Council on Ethical and Judicial Affairs of the American Medical Association concluded that "It is ethically permissible to consider the anencephalic as a potential organ donor, although still alive under the current definition of death," if, among other requirements, the diagnosis is certain and the parents give their permission ( 45). This conclusion was grounded in the Council's judgment that organ procurement from anencephalic newborns would not be an unacceptable harm to the infants because of their extreme degree of neurologic impairment. The Council eventually reversed its view, at least in part because it was not compatible with the dead-donor rule ( 46).

Both the Japanese ( 47) and the Germans ( 48) have been slow to accept organ transplantation, in part because of a general unwillingness to accept that brain-dead patients are really dead. To enable the development of organ transplantation, the Japanese government recently adopted a compromise position, which essentially states that patients who meet brain death criteria may be declared dead, but only for purposes of transplantation. In this case, brain death is defined operationally, and this allows patients who want to be organ donors to be classified as dead so that organ procurement can proceed in compliance with the dead-donor rule. Here again, the dead-donor rule is serving only to obfuscate the central ethical issue, which is whether a patient who desires to donate would be unacceptably harmed by the removal of life-sustaining organs.

Transplant clinicians and the public may well object to reframing the ethical foundations of organ procurement in the way that we have proposed because if patients are not declared dead before organ procurement, then it seems there is no choice but to conclude that the patients are being killed by their doctors. Examination of the lay press would indicate that this is of much greater concern to transplant clinicians than it is to the public. Many journalistic accounts of situations involving brain death include language similar to this quote from the New York Times: "The brain dead are candidates for a donation, but the operation generally must be performed before death" ( 49), or this quote from the Boston Globe: "(the patient) was being kept alive so… doctors could harvest his organs for donation" ( 50). The frequency of this mistake in newspapers and magazines ( 51), and the lack of outraged response from the public, might indicate that the public is fundamentally confused about whether patients are declared dead before transplantable organs are procured. It is an unknown empirical question whether patients and families would be as willing to give permission for organ retrieval on the basis that the patient is in an irretrievable coma as they are on the belief that the patient is dead, but these suggestions from the lay press indicate that the question has yet to be settled.

The concern of clinicians is understandable, but may also deserve reexamination. Clinicians increasingly struggle with the emotional weight of the moral agency that they must bring to life-and-death decisions. Only a few decades ago, physicians argued strenuously that withdrawal of mechanical ventilation from a woman in a permanent vegetative state was unethical because it would mean that the physicians had killed her ( 52). Today, the majority of deaths that occur in intensive care units follow the withholding or withdrawing of some life-sustaining treatment, often the withdrawal of mechanical ventilation ( 53). The point is that physicians must often take actions that result in the imminent deaths of patients and that what was seen as unethical just a few years ago is today not only acceptable, but even ethically required. When physicians remove patients from a ventilator at the end of a terminal illness, we do not say (either descriptively or normatively) that they killed the patient; the cause of the patient's death is attributed to the underlying disease. Parallel reasoning would apply to patients who choose to donate their organs as part of the dying process. In both ventilator withdrawal and organ procurement, the physician acts, and this act is the most proximate cause of the patient's death. In both cases, the physician is not morally responsible for the patient's death-the morally relevant cause of death is the patient's disease. In both cases, the physician is acting with the patient's consent in ways that respect the wishes of the patient and that are in pursuit of morally worthwhile ends. The present practice of defining these patients as dead before organ removal may serve to ease the consciences of the physicians involved, but it does not change the facts of the matter and only serves to perpetuate our confusion about the meaning and ethical import of brain death.

The advantage of our proposal is not that it makes the ethics of organ transplantation any easier. The difficult question "What is death?" is replaced by the equally difficult question "When are patients sufficiently close to death or sufficiently neurologically impaired that they can choose to be an organ donor?" The first question is important, but with the exception of organ transplantation, is adequately addressed by the traditional criteria of circulation and respiration. The answer to the second question would need to be determined through a process of medical, social, and legal deliberation. The advantages of our approach are that (unlike the dead-donor rule) it focuses on the most salient ethical issues at stake, and (unlike the concept of brain death) it avoids conceptual confusion and inconsistencies

Social practices change slowly, and usually for good reason. Just as development and implementation of the concept of brain death took decades, a shift to the ethical paradigm that we propose would likely take at least as long. Such a shift would also require major changes in the current legal interpretation of causation, such that the procurement of transplantable organs before death would not be deemed to be the legal cause of death. These changes would need to ensure that the legal cause of death would be defined as the patient's underlying disease, just as is currently the case when life support is withdrawn. Although these legal hurdles would be very significant, they would not be unprecedented, as evidenced by similar changes that have occurred in the legal view of withdrawal of life support and the definition of death.

In a larger sense, if the immunologic hurdles to xenotransplantation can be overcome, then the ethics of procuring organs from humans will become moot, and our proposal will be irrelevant. The concept of brain death will then disappear from textbooks and the medical literature, illustrating the degree to which the concept was never more than a social construction, developed to meet the needs of the transplantation enterprise during a crucial phase of its development ( 54, 55).