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20 Ethical issues in organ donation after cardiac death
The Case
Mr. Gift is a 59-year-old man who is permanently quadraplegic and ventilator dependent due to a C2–3 fracture dislocation following a fall during an equestrian competition 8 weeks ago. Since the accident he has undergone several surgeries, including C-spine stabilization, tracheostomy, jejunostomy tube placement, and intramedullary fixation of a femur fracture. He is scheduled for a tracheostomy revision tomorrow, due to intermittent partial obstruction of the trachea and tracheal stenosis.
Mr. Gift is awake, alert, and finds life intolerable in his dependent state. He does not want the scheduled surgery. He views his situation as both emotionally and financially draining for his family. In the event of a cardiac arrest, he has stated he does not want to be resuscitated, and he has a Do-Not-Resuscitate (DNR) order in his chart. Mr. Gift has further requested that his ventilator support be terminated, that he be given comfort measures only to relieve dyspnea and anxiety, and that his organs be donated for transplantation after his death. He has read that sometimes life-supporting therapy can be withdrawn in an operating room, and organ procurement carried out immediately after death. In order to provide the greatest possible number of organs, he has talked to an organ procurement organization (OPO) representative, and requests that this be arranged. His family is supportive of the DNR order, but unsure about withdrawal of life-supporting therapy and organ donation.
While discussions are ongoing, Mr. Gift is accidentally extubated while being turned in bed. Attempts to replace the tracheostomy tube fail. By the time the resuscitation team arrives, Mr. Gift is unconscious, hypoxemic, and hypotensive. Physicians are unsure of whether to attempt intubation, given the DNR order. The OPO representative, who happens to be on the unit when these events unfold, demands that they continue to attempt to intubate Mr. Gift and initiate cardiopulmonary resuscitation despite his DNR order, so that arrangements can be made for a controlled cardiac arrest in the OR followed by organ donation per his wishes.
The transplantation program in the US is an altruistic program based on the premise that organ donation is a gift, and relying on ethical principles of autonomy, respect for persons (beneficence, nonmaleficence), and justice. Public confidence in this system assumes obligations of grateful use, grateful conduct, and reciprocation, and the core shared societal values of voluntarism, respect for family preferences, promotion of a sense of community through generosity, and improving the quality of life for others.1 The legislative basis of this system of transplantation is the 1968 Uniform Anatomical Gift Act (UAGA) that defined the ability of individuals to donate their organs via an opt-in approach to organ donation that honored the free “autonomous” choice of individuals to donate their organs via a “first person consent” or “donor designation” process.
Since the early days of organ transplantation, there has been general acceptance of the dead donor rule, an ethical axiom that states it is unethical for organ procurement to cause death or injury and, except in the case of living donation, it is unethical for organ procurement to precede death. This rule illustrates society’s respect for the donor as a person (autonomy), the donor’s interests, and life (nonmaleficence). It was also necessary to safeguard and protect the interests of vulnerable populations, avoid “slippery slope” situations, and to insure public support for a voluntary system of organ donation.2 Adherence to the “dead donor rule” presupposes an acceptable, stringent definition of death.
Defining death
Initially, the only accepted definition of death was cardiopulmonary death, and organs were only procured from nonheartbeating donors. This placed practical limitations on transplantation of many organs, such as hearts, lungs and livers, whose viability declines rapidly with circulatory arrest. In the meantime, redefining death became important for the ever-increasing population of unconscious patients being subjected to aggressive and potentially non-beneficial life-supporting medical therapies. Such patients not only presented ethical and medical dilemmas (resource utilization, futility, end-of-life care and right to die decisions), but were also a potential source of organs for transplantation. In 1968, Henry K. Beecher and the ad hoc committee of the Harvard Medical School defined clinical criteria for “brain death” or death of the whole brain and brainstem.3 (See Chapter 19.)
A legislative “stringent” definition of death in the US was provided by the 1980 Uniform Determination of Death Act (UDDA), which defined death as either cardiopulmonary death (irreversible cessation of circulatory and respiratory function) or brain death (irreversible cessation of all functions of the entire brain and brain stem). Despite this broadening of the definition of death, the shortage of viable organs has remained a problem, and transplant waiting lists continue to grow.a The shortage of organs for transplantation resulted in renewed interest in vital organ procurement from nonheartbeating donors (donation after cardiac death or DCD) in 1992.4
Donation after cardiac death (DCD)
A non-heart-beating organ donor is “[a] cadaver, whose death was determined by demonstrating irreversible cessation of cardiopulmonary function (simultaneous and irreversible unresponsiveness, apnea, and absent circulation) from whom organs are procured.”5 DCD may be “uncontrolled” or “controlled.” Uncontrolled DCD may follow, for example, a failed cardiopulmonary resuscitation. Controlled DCD occurs when organ donation follows death after a planned withdrawal of life support that is expected to result in rapid death (either in the operating room or intensive care unit).
In order for controlled DCD to be ethically acceptable, three independent discussions and questions need to be answered by the prospective donor and/or surrogates without coercion from conflicted parties. Each discussion must be separated from the others by a functional “firewall”. The first is a discussion and decision to forgo resuscitation in the event of cardiopulmonary arrest. Then, a discussion and decision to withdraw life-sustaining therapies with continuation of comfort care can be reached. Finally, and only after the first two decisions have been made, a discussion and decision regarding organ donation can occur. Important procedural questions regarding controlled DCD may only be discussed after a decision regarding organ donation is made. These include where and by whom withdrawal of life-sustaining therapies will occur and informed consent for premortem procedures to promote organ viability – such as placement of vascular cannulae to allow premortem administration of medications to enhance organ preservation, and the infusion of preservative solutions at the time of death.
Life-sustaining therapy may be withdrawn in the intensive care unit or in an operating room with family present. After diagnosis of pulmonary and circulatory arrest, the family, if present, leaves the operating room. A waiting period of 2 to 10 minutes, depending on institutional protocol and national standards, is observed prior to declaring death. Organ procurement can begin once death is declared. In the event that cardiopulmonary death does not occur within a reasonable period of time, often defined as 1–2 hours, the patient is returned to the ICU or to a palliative care unit, and is no longer considered a potential donor.
It was hoped that DCD would significantly reduce the shortage of viable organs for transplantation, as well as provide closure and meaning to patients and their families who wished to donate organs after death. The concept of DCD was supported by the Society of Critical Care Medicine,5 Opinion 2.157 of the AMA’s Code of Medical Ethics,6 the Institute of Medicine (IOM),7 and a national conference on organ donation after cardiac death.8 However, despite increasing annual numbers of DCD donors, they still represented less than 11% of all deceased donors in 2008.9 Attempts to increase the number of DCD donors have included relaxation of the strict criteria for donation after cardiac death, and administrative, legislative, and social changes to the organ donation process. These measures have resulted in ethical and moral controversies and have only increased the public’s preexisting misperceptions and fears regarding organ procurement and DCD. These fears include those of physicians’ potential conflicts of interest favoring donation over saving the life of a “potential donor” or over end-of-life care for the “potential donor”. Other fears include worries that physicians will hasten the death of potential donors to facilitate organ transplantation and fears of not being dead at the time of organ donation. Such fears could potentially result in a decrease in agreements to sign donor cards and increased unwillingness to donate under DCD protocols.10
Legal precedents
Legislative precedents in the United States are unambiguous, allowing any competent or previously competent individual to exercise their autonomous decision to withdraw what they believe are non-beneficial life-sustaining therapies and donate their organs. These autonomous rights to have non-beneficial life sustaining therapies withdrawn in favor of comfort care are supported by the AMA Code of Medical Ethics,11 the American Thoracic Society,12 and a Task Force on Ethics of the Society of Critical Care Medicine.13 Some jurisdictions in the United States do limit the ability to withdraw care in incompetents without clear (advance) directive who are not in a persistent vegetative state.14
Ethical controversies
Ethical dilemmas in DCD are confounded by the fact that DCD combines two morally complex events – decisions and care of the donor at the end of life, and the gift of organ donation. Dilemmas include conflicts of interest in the separation between end-of-life care and donation, use of the presumptive approach to consent (in which the donor is presumed to consent unless concrete proof exists to the contrary), possible violations of the donor’s autonomous wishes when consent is presumed or obtained from surrogates, supremacy of donation over the donor’s advance directives and end-of-life care wishes, the determination of who withdraws life-sustaining therapies, the appropriateness of premortem use of organ protection agents, and the irreversibility of circulatory arrest in the age of cardiopulmonary resuscitation (CPR).
The practice of DCD has been even more ethically problematic than the concept of DCD. In 1998, the Department of Health and Human Services, Health Care Financing Administration (HCFA) changed the Medicare (Hospital) Conditions of Participation (COP) rules to require that a member of the Organ Procurement Organization (OPO) or an OPO trained “designated requestor” initiate the request for organ donation.15 This breached the firewall between end-of-life care and organ donation and presented an extreme conflict of interest, since employees of organizations whose livelihood is to obtain organs for transplantation can clearly not be assumed to represent the donor’s interests first and foremost. The breaking down of barriers between the three critical decisions necessary in DCD – to forgo resuscitation, to end life-sustaining treatments, and to donate vital organs – raises the potential for intended or unintended coercion of the potential donor or their family.
With the change in COP rules, OPOs began to adopt a “presumptive approach” to organ donation, in which it is presumed that patients want to donate organs unless proven otherwise. OPOs justified an aggressive approach by promulgating the belief that everyone should donate organs, since it is the right thing to do, and therefore any approach that leads to increased organ donation may be justified by the beneficent end of more organ availability.16 Since the “rightness” of organ transplantation is far from a universally accepted concept, and even in some cases may violate cultural and religious beliefs of individuals, such beliefs by organ transplant agencies are at the least insensitive, and may at times frankly violate ethical principles of respect for individuals. Many have concluded that this approach is misleading, manipulative and/or coercive, undermines some of the core elements of informed consent, and is ethically questionable under the principle of nonmaleficence.17, 18 Others point out that the involvement early in the process of professionals knowledgeable and involved in organ donation (OPO personnel) may result in a “dual advocacy” that considers the interests of both the donor and their family and the transplant recipient.19
Truog compares organ donation with participation in research, involving altruistic gifts, benefits to others, potential risk or harm to the patient or family, and obligations of clinicians to support the desires of patients.17, 18 He notes that the meticulous safeguards present in research consent are absent in the presumptive approach to consent for organ donation. Clearly, under the principle of nonmaleficence, a potentially coercive, conflicted, and presumptive approach would not be tolerated in research-informed consent. Ultimately, the presumptive approach has the potential to undermine the public’s confidence in the organ procurement process and further decrease the donor pool.
Families that revoke a donor’s autonomous intention to donate present additional practical, ethical, and possibly legal challenges to those involved in organ procurement. In 1998, the Center for Organ Recovery and Education (CORE), an OPO in regions of New York, Pennsylvania, and West Virginia, began a controversial policy of respecting and acting on the documented wishes of the patient to donate independent of the family’s consent. This shifted the approach to families from one of seeking consent, to one of informing that the individual’s documented decision to donate would be respected. It rarely resulted in opposition to the donation by the families. As discussed by May and colleagues,20 there was a firm ethical basis for this policy shift that was morally permissible and morally required. The CORE policy respects: (1) the autonomous rights of patients to donate their organs (respect for persons) by adhering to a donor directive that is definitive and applicable; (2) patients by having their interests survive their death by the fulfillment of their wishes; (3) the grieving families by relieving them of a burdenous decision at a time of loss; and (4) the caregivers, by moving them out of a possible conflict between opposing viewpoints.
Other attempts to increase the donor pool have not been so enthusiastically supported in the United States. Pressure from advocacy groups, such as the Presumed Consent Foundation,21 to shift the national organ transplant system to an opt-out program in which an individual would be required to register opposition to avoid automatically becoming an organ donor upon death, is extremely controversial. Although considered by national organizations such as the American Medical Association, the Health and Human Services Advisory Committee on Organ Transplantation, and UNOS as a means of increasing organ donation, well accepted as national policy in some European countries, and supported by British Prime Minister Gordon Brown, a shift in US national organ donation policy to that of presumed consent was neither supported by a 1994 US survey (71% of those opposed the practice )22 nor a 2006 IOM report.23 Differences in primary ethical priorities from autonomy and beneficence in the United States to beneficence and social justice in the European Union may account for this. Concerns in such an opt-out system include the protection of vulnerable populations such as non- or poorly English speaking persons, the young, elderly, and those who are educationally, economically, or socially disadvantaged. Such populations may neither be aware of the need to actively “opt-out” nor have access to resources to make sure that they can exercise such options.
A more recent legislative attempt to increase the number of organ donors included the 2006 revision of the UAGA,24 which had both unintended and unacceptable consequences for end-of-life care. The ethical and legislative problems for end-of-life medical decision-making that were raised by UAGA 2006 are discussed in detail in Chapter 21.
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