PERSPECTIVE THE DEADDONOR RULE clinical team, the ethics commit- patients are permanently uncon- patients should be permitted to tee, and the hospital administra- scious and cannot live without a donate vital organs except in cir- tion, it was not honored because ventilator. Recovery of their organs cumstances in which doing so multiple surgeons who were con- is therefore considered accept- would harm them; and they would tacted refused to recover the or- able if organ donation is desired not be harmed when their death gans: the rules of the United by the patient or by the surrogate was imminent owing to a deci Network for Organ Sharing on the patient's behalf sion to stop life support. That (UNOS)state that the patient More recently, to meet the ever- patients be dead before their must give direct consent for liv- growing need for transplantable organs are recovered is not a ing donation, which this patient's organs, attention has turned to foundational ethical requirement neurologic injury rendered im- donors who are declared dead on Rather, by blocking reasonable possible. Consequently, he died the basis of the irreversible loss requests from patients and fami without the opportunity to do- of circulatory function. Here again, lies to donate, the ddr both in- te. If there were no require- we struggle with the need to de- fringes donor autonomy and un ment to comply with the DDR, clare death when organs are still necessarily limits the number and he family would have been per- viable for transplantation. This quality of transplantable organs mitted to donate all the patient's requirement has led to rules per- Many observers nevertheless in vital organs. mitting organ procurement after sist that the dDr must be upheld Allegiance to the DDr thus the patient has been pulseless for to maintain public trust in the limits the procurement of trans- at least 2 minutes. Yet for many organ-transplantation enterprise plantable organs by denying some such patients, circulatory function However, the limited available patients the option to donate in is not yet irreversibly lost within evidence suggests that a sizeable situations in which death is im- this timeframe - cardiopulmo- proportion of the public is less minent and donation is desired. nary resuscitation could restore it. concerned about the timing of But the problems with the DDr So a compromise has been reached death in organ donation than go deeper than that. The DDr has whereby organ procurement may about the process of decision required physicians and society begin before the loss of circula- making and assurances that th to develop criteria for declaring tion is known to be irreversible, patient will not recover patients dead while their organs provided that clinicians wait long cerns that are compatible with are still alive. The first enough to have confidence that an ethical focus on autonomy and to this challenge was the heart will not restart on its nonmaleficence. 5 ment of the concept of patient or surro- Although shifting the ethical death. Patients meeting criteria gate agrees that resuscitation will foundation of organ donation for brain death were originally not be attempted (since such an from the ddr to the principles considered to be dead because attempt could result in a patient's of autonomy and nonmaleficence they had lost "the integrated being "brought back to life"after would require creation of legal functioning of the organism as a having been declared dead exceptions to our homicide laws, whole, "a scientific definition of Reasonable people could hard- this would not be the first time life reflecting the basic biologic ly be faulted for viewing these we have struggled to reconcile concept of homeostasis. 2 Over the compromises as little more than laws with the desire of individual past several decades, however, it medical charades. We therefore patients to die in the manner of has become clear that patients suggest that a sturdier founda- their own choosing In the 1970s, diagnosed as brain dead have not tion for the ethics of organ trans- patients won the right to have lost this homeostatic balance but plantation can be found in two ventilator use and other forms of can maintain extensive integrat- fundamental ethical principles: life support discontinued, despite ed functioning for years. 3 Even autonomy and nonmaleficence. physicians'arguments that doing though brain death is not com- Respect for autonomy requires so would constitute unlawful kill patible with a scientific under- that people be given choices in ing. Since that time, physicians standing of death, its wide ac- the circumstances of their dying, have played an active role in deci ceptance suggests that other including donating organs. Non- sions about whether and when factors help to justify recovery of maleficence requires protecting life support should be withdrawn, organs. For example, brain-dead patients from harm. Accordingly, and the willingness of physicians 1288 N ENGL J MED 369: 14 NEJM.ORG OCTOBER 3, 2013PERSPECTIVE 1288 n engl j med 369;14 nejm.org october 3, 2013 clinical team, the ethics commit￾tee, and the hospital administra￾tion, it was not honored because multiple surgeons who were con￾tacted refused to recover the or￾gans: the rules of the United Network for Organ Sharing (UNOS) state that the patient must give direct consent for liv￾ing donation, which this patient’s neurologic injury rendered im￾possible. Consequently, he died without the opportunity to do￾nate. If there were no require￾ment to comply with the DDR, the family would have been per￾mitted to donate all the patient’s vital organs. Allegiance to the DDR thus limits the procurement of trans￾plantable organs by denying some patients the option to donate in situations in which death is im￾minent and donation is desired. But the problems with the DDR go deeper than that. The DDR has required physicians and society to develop criteria for declaring patients dead while their organs are still alive. The first response to this challenge was develop￾ment of the concept of brain death. Patients meeting criteria for brain death were originally considered to be dead because they had lost “the integrated functioning of the organism as a whole,” a scientific definition of life reflecting the basic biologic concept of homeostasis.2 Over the past several decades, however, it has become clear that patients diagnosed as brain dead have not lost this homeostatic balance but can maintain extensive integrat￾ed functioning for years.3 Even though brain death is not com￾patible with a scientific under￾standing of death, its wide ac￾ceptance suggests that other factors help to justify recovery of organs. For example, brain-dead patients are permanently uncon￾scious and cannot live without a ventilator. Recovery of their organs is therefore considered accept￾able if organ donation is desired by the patient or by the surrogate on the patient’s behalf. More recently, to meet the ever￾growing need for transplantable organs, attention has turned to donors who are declared dead on the basis of the irreversible loss of circulatory function. Here again, we struggle with the need to de￾clare death when organs are still viable for transplantation. This requirement has led to rules per￾mitting organ procurement after the patient has been pulseless for at least 2 minutes. Yet for many such patients, circulatory function is not yet irreversibly lost within this timeframe — cardiopulmo￾nary resuscitation could restore it. So a compromise has been reached whereby organ procurement may begin before the loss of circula￾tion is known to be irreversible, provided that clinicians wait long enough to have confidence that the heart will not restart on its own, and the patient or surro￾gate agrees that resuscitation will not be attempted (since such an attempt could result in a patient’s being “brought back to life” after having been declared dead). Reasonable people could hard￾ly be faulted for viewing these compromises as little more than medical charades. We therefore suggest that a sturdier founda￾tion for the ethics of organ trans￾plantation can be found in two fundamental ethical principles: autonomy and nonmaleficence.4 Respect for autonomy requires that people be given choices in the circumstances of their dying, including donating organs. Non￾maleficence requires protecting patients from harm. Accordingly, patients should be permitted to donate vital organs except in cir￾cumstances in which doing so would harm them; and they would not be harmed when their death was imminent owing to a deci￾sion to stop life support. That patients be dead before their organs are recovered is not a foundational ethical requirement. Rather, by blocking reasonable requests from patients and fami￾lies to donate, the DDR both in￾fringes donor autonomy and un￾necessarily limits the number and quality of transplantable organs. Many observers nevertheless in￾sist that the DDR must be upheld to maintain public trust in the organ-transplantation enterprise. However, the limited available evidence suggests that a sizeable proportion of the public is less concerned about the timing of death in organ donation than about the process of decision making and assurances that the patient will not recover — con￾cerns that are compatible with an ethical focus on autonomy and nonmaleficence.5 Although shifting the ethical foundation of organ donation from the DDR to the principles of autonomy and nonmaleficence would require creation of legal exceptions to our homicide laws, this would not be the first time we have struggled to reconcile laws with the desire of individual patients to die in the manner of their own choosing. In the 1970s, patients won the right to have ventilator use and other forms of life support discontinued, despite physicians’ arguments that doing so would constitute unlawful kill￾ing. Since that time, physicians have played an active role in deci￾sions about whether and when life support should be withdrawn, and the willingness of physicians The Dead-Donor Rule