PERSPECTIVE THE DEAD-DONOR RULE to accept this active role in the dy- others to live, even if that means ments of Medicine, Biostatistics and Epide Policy, and the Fostering Impro rather than eroded, the public their death. We believe that poli- End-of-Life Decision Science(FIELDS) trust in the profession. cymakers should take these Our society generally supports zens' requests seriously and be- nia, Philadelphia(SDH ) the view that people should be gin to engage in a discussion 1. Sanghavi D When does death start? New granted the broadest range of about abandoning the DDr. freedomscompatiblewithassurTheviewsexpressedarethoseoftheau.(http://www.nytimes.com/2009/12/20/ azine/20organ-t html pagewanted=all& ance of the same for others som e thors and do not necessarily reflect the pol- _r-O icy of the National Institutes of Health, the 2. Bernat JL, Culver CM, Gert B. On the defi. people may sona mora Public Health Service, or the Department of nition and criterion of death. Ar views that preclude the approach Health and Human Service 198194389-94. should be respected. Neverthe- are available with the full text of this article 5. car>11998 511538-4al conseque ath we describe here. and these views Disclosure forms provided by the author 3. Shewmon DA.Chronic"brain less, the views of people who provide no basis for denying such of Global k mope and the Department Univer itfF LA. B: 2012 opt organ transplantation: recor and so eal ethics at the end of life. New york oxford liberties to those who wish to of Anesthesiology, Perioperative and Pain 5. Simin Youngner S). Death pursue them. When death is very Medicine, Boston Children's Hospital- and organ procurement: public beliefs and at near, some patients may want to Bioethics, National Institutes of Health, DOl: 10.1056/NEJMp1307220 die in the process of helping Bethesda, MD(FG M); and the Depart. Copyright e 2013 Massachusetts Medical Society Life or death for the dead-Donor rule? James L Bernat, M D he increasing disproportion cently proposed by Paul Morrissey an informal, succinct standard between the supply of donor of Brown University. This proto- highlighting the relationship be- organs and the demand for col permits a lawful surrogate tween the two most relevant laws transplants as well as the tragic decision maker for a patient with governing organ donation from deaths of patients awaiting or- a severe, irreversible brain injury deceased do the Uniform gans have encouraged the devel-(but who is not "brain dead")to Anatomical Gift Act and state opment of creative solutions to authorize withdrawal of life-sus- homicide law. The DDR states increase the donor supply. In the taining treatment and premortem that organ donation must not domain of donation from de- donation of both kidneys. Where- kill the donor; thus, the donor ceased donors, the protocols for as DCDD protocols entail removal must first be declared dead. It organ donation after the circu- of organs after the cessation of applies only to organ donation latory determination of death life-sustaining therapy and the from deceased donors, not to liv (DCDD) have been one such re- subsequent declaration of death, ing donation, such as that of one sponse. Most U.S. organ-procure- the Morrissey protocol provides kidney or a partial liver. Morris ment organizations have seen for procuring organs while the sey's protocol does not violate organs from DCDd protocols patient remains alive. Life-sus- the ddr because it is a type of account for a growing percent- taining treatment is withdrawn living organ donation that does age of all organs donated from after the donation has been ac- not kill the donor. The donor deceased donors(see graph). In complished. The patient dies of dies not as a result of the azo- England, DCDD organs currently the respiratory complications of temic consequences of the dona constitute a greater percentage the original brain which tion of both kidneys but earlier, than organs donated after the is fatal in the absence of life-sus- of respiratory arrest. determination of death by brain taining treatment. hat the act of organ donation criteria ("donation after the brain Some commentators have must not kill the donor has been determination of death, "or DBDD). claimed that Morrissey's proto- regarded as the ethical and legal Another innovative strategy is col violates the dead-donor rule foundation of organ donation the kidney-donation protocol re- (DDR). The ddr is not a law but from its earliest days. John Rob N ENGLJ MED 369: 14 NEJM.ORG OCTOBER 3, 2013
n engl j med 369;14 nejm.org october 3, 2013 PERSPECTIVE 1289 The Dead-Donor Rule to accept this active role in the dying process has probably enhanced, rather than eroded, the public trust in the profession. Our society generally supports the view that people should be granted the broadest range of freedoms compatible with assurance of the same for others. Some people may have personal moral views that preclude the approach we describe here, and these views should be respected. Nevertheless, the views of people who may freely avoid these options provide no basis for denying such liberties to those who wish to pursue them. When death is very near, some patients may want to die in the process of helping others to live, even if that means altering the timing or manner of their death. We believe that policymakers should take these citizens’ requests seriously and begin to engage in a discussion about abandoning the DDR. The views expressed are those of the authors and do not necessarily reflect the policy of the National Institutes of Health, the Public Health Service, or the Department of Health and Human Services. Disclosure forms provided by the author are available with the full text of this article at NEJM.org. From the Departments of Anesthesia and of Global Heath and Social Medicine, Harvard Medical School, and the Department of Anesthesiology, Perioperative and Pain Medicine, Boston Children’s Hospital — both in Boston (R.D.T.); the Department of Bioethics, National Institutes of Health, Bethesda, MD (F.G.M.); and the Departments of Medicine, Biostatistics and Epidemiology, and Medical Ethics and Health Policy, and the Fostering Improvement in End-of-Life Decision Science (FIELDS) program — all at the University of Pennsylvania, Philadelphia (S.D.H.). 1. Sanghavi D. When does death start? New York Times Magazine. December 16, 2009 (http://www.nytimes.com/2009/12/20/ magazine/20organ-t.html?pagewanted=all& _r=0). 2. Bernat JL, Culver CM, Gert B. On the definition and criterion of death. Ann Intern Med 1981;94:389-94. 3. Shewmon DA. Chronic “brain death”: meta-analysis and conceptual consequences. Neurology 1998;51:1538-45. 4. Miller FG, Truog RD. Death, dying, and organ transplantation: reconstructing medical ethics at the end of life. New York: Oxford University Press, 2012. 5. Siminoff LA, Burant C, Youngner SJ. Death and organ procurement: public beliefs and attitudes. Kennedy Inst Ethics J 2004;14:217-34. DOI: 10.1056/NEJMp1307220 Copyright © 2013 Massachusetts Medical Society. Life or Death for the Dead-Donor Rule? James L. Bernat, M.D. The increasing disproportion between the supply of donor organs and the demand for transplants as well as the tragic deaths of patients awaiting organs have encouraged the development of creative solutions to increase the donor supply. In the domain of donation from deceased donors, the protocols for organ donation after the circulatory determination of death (DCDD) have been one such response. Most U.S. organ-procurement organizations have seen organs from DCDD protocols account for a growing percentage of all organs donated from deceased donors (see graph). In England, DCDD organs currently constitute a greater percentage than organs donated after the determination of death by brain criteria (“donation after the brain determination of death,” or DBDD). Another innovative strategy is the kidney-donation protocol recently proposed by Paul Morrissey of Brown University.1 This protocol permits a lawful surrogate decision maker for a patient with a severe, irreversible brain injury (but who is not “brain dead”) to authorize withdrawal of life-sustaining treatment and premortem donation of both kidneys. Whereas DCDD protocols entail removal of organs after the cessation of life-sustaining therapy and the subsequent declaration of death, the Morrissey protocol provides for procuring organs while the patient remains alive. Life-sustaining treatment is withdrawn after the donation has been accomplished. The patient dies of the respiratory complications of the original brain injury, which is fatal in the absence of life-sustaining treatment. Some commentators have claimed that Morrissey’s protocol violates the dead-donor rule (DDR). The DDR is not a law but an informal, succinct standard highlighting the relationship between the two most relevant laws governing organ donation from deceased donors: the Uniform Anatomical Gift Act and state homicide law. The DDR states that organ donation must not kill the donor; thus, the donor must first be declared dead. It applies only to organ donation from deceased donors, not to living donation, such as that of one kidney or a partial liver. Morrissey’s protocol does not violate the DDR because it is a type of living organ donation that does not kill the donor. The donor dies not as a result of the azotemic consequences of the donation of both kidneys but earlier, of respiratory arrest. That the act of organ donation must not kill the donor has been regarded as the ethical and legal foundation of organ donation from its earliest days. John Rob-
PERSPECTIVE LIFE OR DEATH FOR THE DEAD-DONOR RULES Living donors 14.000 rain criteria Deceased donors 11,000 9,000 oE86z 5.000 1,000 2002200320042005200620072008200920102011 Organ Donation in the United States by Donor Status, 2002-2011. Data are from the Scientific Registry of Transplant Recipients ertson, the scholar most closely medical practice and that it im- ally declared. 4 The standards for associated with the DDR, has pedes increased organ donation the circulatory determination provided its ethical and legal (see Perspective article by truog death remain a matter of debate, footing. Robertson explains that et al., pages 1287-1289).3 Such though reasoned standards are than a utilitarian rule because it the dDR with the voluntary con- sions are ongoing about a scus. the ddr is a deontological rather scholars have proposed replacing emerging. In particular, di forbids causing a person,s death sent of the dying patient who is imum required duration of asy by removing organs for needy re- beyond harm to donate organs tole before death can be declared cipients, even with the potential before death. These conditions, and whether cessation of circula- donor's consent. Arguing that the they argue, represent sufficient tion must be irreversible(cannot DDR protects vulnerable people, grounds for surgeons to remove be reversed), as stipulated in many such as anencephalic infants and organs, even if doing so causes death statutes, or merely perma- incarcerated prisoners(whose use the donor's death 3 I believe that, nent(will not be reversed), as is as organ donors had previously although there are informed pa- traditionally accepted by physi been proposed and rejected), he tients for whom this practice cians. 5 The Institute of Medicine considers the rule " a centerpiece would work, violating the DDR is and the U.S. Department of of the social orders commitment misguided and will lead fearful Health and Human Services to respect for persons and hu- patients to lose trust in physicians strongly support DCDD and rec- man life. "And he emphasizes and confidence in the organ- ommend its more widespread that the ddR helps to maintain donation system and will result implementation in hospitals-a public trust in the organ-pro- in an overall decline in organ process that is well under way curement system, calling it"the donation. Some critics of the brain or cal linchpin ary One barrier to implementing circulatory determination of death system of organ donation. "2 DCDD protocols is the concern, reject the prevailing choice for Over the past decade, several expressed in surveys of the pub- the moment of death -that scholars have called for the aban- lic and of health care profession- point separating the process of donment of the DDR, claiming als, that the donor is not actually dying in a living patient from the that it is routinely violated in dead at the moment death is usu- process of bodily disintegration 1290 N ENGL J MED 369: 14 NEJM.ORG OCTOBER 3, 2013
PERSPECTIVE 1290 n engl j med 369;14 nejm.org october 3, 2013 ertson, the scholar most closely associated with the DDR, has provided its ethical and legal footing. Robertson explains that the DDR is a deontological rather than a utilitarian rule because it forbids causing a person’s death by removing organs for needy recipients, even with the potential donor’s consent. Arguing that the DDR protects vulnerable people, such as anencephalic infants and incarcerated prisoners (whose use as organ donors had previously been proposed and rejected), he considers the rule “a centerpiece of the social order’s commitment to respect for persons and human life.” And he emphasizes that the DDR helps to maintain public trust in the organ-procurement system, calling it “the ethical linchpin of a voluntary system of organ donation.”2 Over the past decade, several scholars have called for the abandonment of the DDR, claiming that it is routinely violated in medical practice and that it impedes increased organ donation (see Perspective article by Truog et al., pages 1287–1289).3 Such scholars have proposed replacing the DDR with the voluntary consent of the dying patient who is beyond harm to donate organs before death. These conditions, they argue, represent sufficient grounds for surgeons to remove organs, even if doing so causes the donor’s death.3 I believe that, although there are informed patients for whom this practice would work, violating the DDR is misguided and will lead fearful patients to lose trust in physicians and confidence in the organdonation system and will result in an overall decline in organ donation. One barrier to implementing DCDD protocols is the concern, expressed in surveys of the public and of health care professionals, that the donor is not actually dead at the moment death is usually declared.4 The standards for the circulatory determination of death remain a matter of debate, though reasoned standards are emerging.5 In particular, discussions are ongoing about the minimum required duration of asystole before death can be declared and whether cessation of circulation must be irreversible (cannot be reversed), as stipulated in many death statutes, or merely permanent (will not be reversed), as is traditionally accepted by physicians.5 The Institute of Medicine and the U.S. Department of Health and Human Services strongly support DCDD and recommend its more widespread implementation in hospitals — a process that is well under way. Some critics of the brain or circulatory determination of death reject the prevailing choice for the moment of death — that point separating the process of dying in a living patient from the process of bodily disintegration Life or Death for the Dead-Donor Rule? No. of Donors 10,000 4,000 5,000 1,000 6,000 2,000 3,000 0 7,000 8,000 9,000 11,000 12,000 13,000 14,000 15,000 Deceased donors, declared dead by brain criteria Deceased donors, declared dead by circulatory criteria Living donors 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 Organ Donation in the United States by Donor Status, 2002–2011. Data are from the Scientific Registry of Transplant Recipients
PERSPECTIVE LIFE OR DEATH FOR THE DEAD-DONOR RULE in a dead person. In non-dona- the concepts of death and crite- ing donation consent rates by en tion circumstances, the precise ria for determining it in both hancing family education and moment separating alive from DBDD and DCDD, reviews of communication, optimizing end dead is usually inconsequential, professional and public opinion of-life care for donors while sup- because physicians declaring death from several studies reveal strong porting grieving families, and have the luxury of time. In the support for the DDr. Indeed, developing state donor registries circumstances of donation, tim- the DDR is so clearly regarded as to authorize first-person donor ing is critical to minimize warm an axiom that survey questions consent. Recognizing that the ischemic exposure of the organs assume its essential role and in- harms of abandoning the DDR being transplanted. Thus, a rea- quire whether the protocols for exceeded the benefits, John Rob- soned judgment must be made DCDd or DBDD violate it. 4 ertson proposed a two-part pru- about the moment of death that I believe that the DDR is an dential test for assessing pro is conceptually coherent, physio- indispensable ethical protection posed changes to the rule, asking logically plausible, and socially for dying patients who plan to what effect they would have on acceptable donate organs and one that the protection of vulnerable per- Physicians should apply the strengthens public trust and con- sons and on preserving the pub- circulatory criterion for death fidence in our voluntary system lic trust. 2 These essential questions similarly whether or not organs of organ donation. Public sup- need to be answered conclusively are intended to be donated. port for organ donation is broad before our society considers aban When a dying patient with a but shallow. It remains precari- doning the DDr. do-not-resuscitate (dnr order ous and can be shaken dramati inclosure forms provided by the author is not an organ donor, death is cally by highly publicized dona- are available with the full text of this arti. usually declared at the moment tion scares such as those following cle at NEJM or of asystole, a time when it still a BBC Panorama expose in 1980, might be possible to resuscitate CBS's 1997 report on 60 Minutes he Departments of Neurology and ne. Geisel School of Medicine at the patient if cardiopulmonary about the Cleveland Clinics con- uth. Hanover NH resuscitation(CPR) were attempt- sideration of a DCDD protocol ed. Thus, physicians require only and the story of the California 1. Morrissey PE. The case for kidney dona. the permanent cessation of circu- transplant surgeon who allegedly 2012: 12: 1-8 lation in order to declare death. wrote terminal care orders for an 2. Robertson JA. The dead donor rule. Hast clared when circulation has per- ple harbor a fear that physicians dono r frep1999:29(): 6 In DCDD donors, too, death is de- organ donor in 2006. Many peo- ings cent rug RD, Brock DW. The dead manently ceased. Permanence is have a greater interest in procur- Med Philos 2010,35: 299-3 4. Bastami S. Matthes o Krones T. Biller. that sufficient time has elapsed welfare. They need the reassur- toward donation after cardiac death amon after the occurrence of asystole ance provided by the DDR. In healthcare providers and the general public to assure that circulation will not 2006. the Institute of Medicine Crit Care Med 2013: 41: 897-905 restart spontaneously(autoresus- supported the DDR as a protec- determining death in critical care. nat re citation)and that CPR will not be tive standard necessary to instill Neurol 2013: 9:164-73 Do:10.1056/NEMp1308078 Although public-survey data I favor strategies to increase Copyrighto2013Massachusetts Medical Society. consistently reveal confusion over the organ supply such as improv- What Would you do if it Were your kid? David n. krones md know we're not supposed to though her curly brown hair had tumor recurred, her parents and have favorites, but Lizzy was long since fallen out because of I knew she would ultimately die one of mine. She was 8 years old. radiation and chemotherapy for a of her disease. But she felt fine, Her eyes still sparkled, even malignant brain tumor. When the and it was impossible not to give ENGLJMED 369: 14 NEJM.ORG OCTOBER 3, 2013
n engl j med 369;14 nejm.org october 3, 2013 PERSPECTIVE 1291 Life or Death for the Dead-Donor Rule? in a dead person. In non-donation circumstances, the precise moment separating alive from dead is usually inconsequential, because physicians declaring death have the luxury of time. In the circumstances of donation, timing is critical to minimize warm ischemic exposure of the organs being transplanted. Thus, a reasoned judgment must be made about the moment of death that is conceptually coherent, physiologically plausible, and socially acceptable. Physicians should apply the circulatory criterion for death similarly whether or not organs are intended to be donated. When a dying patient with a do-not-resuscitate (DNR) order is not an organ donor, death is usually declared at the moment of asystole, a time when it still might be possible to resuscitate the patient if cardiopulmonary resuscitation (CPR) were attempted. Thus, physicians require only the permanent cessation of circulation in order to declare death. In DCDD donors, too, death is declared when circulation has permanently ceased. Permanence is established by two conditions: that sufficient time has elapsed after the occurrence of asystole to assure that circulation will not restart spontaneously (autoresuscitation) and that CPR will not be administered.5 Although public-survey data consistently reveal confusion over the concepts of death and criteria for determining it in both DBDD and DCDD, reviews of professional and public opinion from several studies reveal strong support for the DDR.4 Indeed, the DDR is so clearly regarded as an axiom that survey questions assume its essential role and inquire whether the protocols for DCDD or DBDD violate it.4 I believe that the DDR is an indispensable ethical protection for dying patients who plan to donate organs and one that strengthens public trust and confidence in our voluntary system of organ donation. Public support for organ donation is broad but shallow. It remains precarious and can be shaken dramatically by highly publicized donation scares such as those following a BBC Panorama exposé in 1980, CBS’s 1997 report on 60 Minutes about the Cleveland Clinic’s consideration of a DCDD protocol, and the story of the California transplant surgeon who allegedly wrote terminal care orders for an organ donor in 2006. Many people harbor a fear that physicians have a greater interest in procuring their organs than in their welfare. They need the reassurance provided by the DDR. In 2006, the Institute of Medicine supported the DDR as a protective standard necessary to instill public confidence. I favor strategies to increase the organ supply such as improving donation consent rates by enhancing family education and communication, optimizing endof-life care for donors while supporting grieving families, and developing state donor registries to authorize first-person donor consent. Recognizing that the harms of abandoning the DDR exceeded the benefits, John Robertson proposed a two-part prudential test for assessing proposed changes to the rule, asking what effect they would have on the protection of vulnerable persons and on preserving the public trust.2 These essential questions need to be answered conclusively before our society considers abandoning the DDR. Disclosure forms provided by the author are available with the full text of this article at NEJM.org. From the Departments of Neurology and Medicine, Geisel School of Medicine at Dartmouth, Hanover, NH. 1. Morrissey PE. The case for kidney donation before end-of-life care. Am J Bioeth 2012;12:1-8. 2. Robertson JA. The dead donor rule. Hastings Cent Rep 1999;29(6):6-14. 3. Miller FG, Truog RD, Brock DW. The dead donor rule: can it withstand critical scrutiny? J Med Philos 2010;35:299-312. 4. Bastami S, Matthes O, Krones T, BillerAndorno N. Systematic review of attitudes toward donation after cardiac death among healthcare providers and the general public. Crit Care Med 2013;41:897-905. 5. Bernat JL. Controversies in defining and determining death in critical care. Nat Rev Neurol 2013;9:164-73. DOI: 10.1056/NEJMp1308078 Copyright © 2013 Massachusetts Medical Society. What Would You Do if It Were Your Kid? David N. Korones, M.D. I know we’re not supposed to have favorites, but Lizzy was one of mine. She was 8 years old. Her eyes still sparkled, even though her curly brown hair had long since fallen out because of radiation and chemotherapy for a malignant brain tumor. When the tumor recurred, her parents and I knew she would ultimately die of her disease. But she felt fine, and it was impossible not to give
