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Abstract

Organ transplantation can extend life and improve the quality of life of patients. Organ transplantation raises a number of signiﬁcant ethical issues ranging from how living and deceased donors become donors and how organs are allocated. The number of patients who could beneﬁt from transplantation far exceeds the number of organs available despite efforts to increase the number of organs available, a circumstance that raises important ethical questions.

Introduction

History And Development Of Organ Transplantation

The ﬁrst organ transplants, attempted in the early 1900s using animal kidneys and in the 1930s using human kidneys from cadavers, failed for two main reasons: ischemic damage to the organs and the recipient’s immune response to the organs. The ﬁrst successful kidney transplants were performed in the 1950s, transplanting a kidney from one living identical twin to another, avoiding the immunological problems previously encountered. Successful liver and heart transplants followed in the 1960s. Immune response remained a signiﬁcant barrier to successful transplantation until the mid-1970s with the development of cyclosporin which, together with surgical advances, led to signiﬁcant success in transplantation of the kidney, heart, liver, lung, bowel, and pancreas between the mid-1970s and throughout the 1980s. Organ transplantation requires lifelong immunosuppression of the recipient, which involves signiﬁcant cost and can have adverse effects on the patient’s health and quality of life.

Although the ﬁrst successful kidney transplants were from living donors and transplants during the 1960s continued to use either living kidney donors or organs from persons declared dead after their hearts stopped, the use of organs from cadavers quickly became the standard after criteria for determining death using neurological criteria were established and so-called brain death was recognized legally as death. This allowed for greater success in transplantation. More organs became available and organs could be preserved by maintaining cadavers on mechanical support, avoiding ischemic damage.

As the number of people seeking transplants has grown and the number of people donating organs after death has leveled off, efforts have been made to secure organs from other types of donors, namely, living donors and individuals who are declared dead using cardiorespiratory criteria (donation after cardiac or circulatory death or DCD) rather than neurological criteria. Another way to increase the population of donors has been to expand the criteria for donor eligibility. Much less common have been efforts to successfully transplant animal organs into humans. Bioengineered organs might change transplantation in the future.

Defining And Determining Death

The dead donor rule refers to the requirement that, with the exception of living donors, organ donors must be dead before their organs are removed. Organ donation may not be the cause of death, for example, removing a heart from a person who is nearly dead and expected to die soon would be the cause of death and is not permitted.

Traditionally, death has been declared using cardiorespiratory criteria – persons were dead when their hearts stopped and they were no longer breathing. With the advent of intensive care medicine, patients who previously would have died because they could not breathe on their own were being kept alive. Questions emerged about the permissibility of removing life support, which would lead to the cessation of circulation and respiration. Many were keen to ensure that physicians not be seen as killing patients by stopping treatment. If those patients already were dead before treatment is stopped, then it would be appropriate to stop mechanical interventions and other support. The patients would not die because treatment was withheld. At the same time, there was a growing desire to make organs available for transplantation and to avoid ischemic damage to those organs. If some patients receiving intensive care already were dead and it was permissible to stop life-sustaining measures such as mechanical ventilation, some thought it might be permissible to remove their organs while their bodies were being maintained with intensive care measures. Organ removal would not be the cause of death since they already were dead, and the organs would be better protected from ischemic damage.

In 1968, Henry Beecher assembled the Ad Hoc Committee of the Harvard Medical School to Examine the Deﬁnition of Brain Death, which aimed to establish a new criterion for death – irreversible coma. Their work revolved around the question of whether there were patients being maintained using intensive care measures who already were dead because no central nervous system activity could be detected. This report suggests that there are two different ways of establishing that a patient has died. One is the use of cardiorespiratory criteria and the other is the use of neurological criteria (Beecher 1968). Laws incorporating this second way of determining death were adopted over time in many developed nations, though cultural acceptance and understanding of brain death often has not tracked the law (Wijdicks 2002; DuBois and Anderson 2006).

If patients can be declared dead when the functions of the brain have ceased irreversibly, physicians must know which brain functions must have ceased irreversibly and how to determine whether the relevant functions have ceased irreversibly.

Disagreement persists regarding the tests that are necessary and sufﬁcient to show that this is the case (Wijdicks 2002) and whether the whole brain, higher brain, or brain stem is the relevant focus of neurological criteria for death.

This variation might contribute to disagreements regarding the use of neurological criteria to declare death. If a patient declared dead in one institution or jurisdiction would not (yet) meet all of the criteria necessary to be declared dead in a different situation, it is understandable that declarations of death using neurological criteria would raise concerns for some.

For some people, the claim that a patient who appears to be profoundly injured but breathing albeit with mechanical support is dead is implausible. Much confusion has been documented among the public and health care professionals and, even where the law recognizes death declared using neurological criteria and cardiorespiratory criteria as equivalent, individuals might not recognize them as such (DuBois and Anderson 2006).

Signiﬁcant cultural and religious factors affect acceptance of neurological death as death. For example, some Orthodox Jews reject neurological criteria for declaring death (Breitowitz 1996).

Japan, a late adopter of a brain death law among developed nations, still faces signiﬁcant cultural opposition to neurological criteria for determining death (Asai et al. 2012). Among those who object to neurological criteria for determining death and do not recognize patients who meet those criteria as dead, some believe that it is wrong to use those patients as donors and others argue that we should abandon the requirement that patients be dead before they become donors (Truog and Miller 2008).

Historically death was declared using cardiorespiratory criteria. One would expect that declaring patients dead when their heart stops and they stop breathing would not be controversial. However, with the reintroduction of donation after cardiac (or circulatory) death practices, differences in how cardiorespiratory criteria for death are applied have raised a number of concerns/have become important. Key areas of variation include the diagnostic tests that must be used and the amount of time that must pass after cardiac arrest before a physician may declare the patient dead and remove organs (Dhanani et al. 2012).

Organ Donation: Three Categories Of Donors

Organs for transplantation come from three main categories of donors: deceased donors declared dead using neurological criteria (“brain dead” donors), deceased donors declared dead using cardiorespiratory or circulatory criteria (so-called non-heart-beating donors or donation after cardiac death (DCD) donors), and living donors.

The term “expanded criteria donor” refers to organ donors of any type who do not meet the standard requirements for donating because, for example, they are older than the accepted age limit in a jurisdiction or have a medical condition that ordinarily would exclude them as donors. Standard criteria are in place to maximize the quality of the organs transplanted and the chance that the transplant will be successful. Expanded criteria organ transplants have higher graft failure rates than standard criteria transplants. The use of expanded criteria (or nonideal) donors raises a number of questions. These include how to balance the risks of using a lower quality organ with the risks of dying while waiting, how much information about the risks of remaining on the waiting list for too long versus the risks of receiving an expanded criteria organ should be provided to potential organ recipients and how this information should be explained, and how recipients of expanded criteria organs should be treated in the case of graft failure.

Donors Declared Dead Using Neurological Criteria

Individuals declared dead using neurological criteria typically have suffered a traumatic injury that cuts off the brain’s oxygen supply, such as a motor vehicle accident or aneurysm. Their bodies are maintained in an intensive care setting using mechanical ventilation and other support to keep organs healthy. These measures are maintained as the donor is taken to the operating room and organ recovery begins. Organs are cooled and preserved until they can be transplanted. These donors may donate their heart, lungs, liver, pancreas, kidneys, and intestinal organs.

Controversies regarding the deﬁnition and determination of death using neurological criteria are important to discussions about organ donation by donors declared dead using “brain death” criteria. Families who do not recognize that a person who appears to be profoundly injured and unconscious but breathing (with mechanical support) can be dead may object to organ donation, for example.

Donors Declared Dead Using Cardiorespiratory Criteria

Although in the early days of organ transplantation deceased donors were declared dead using cardiorespiratory criteria, these donors were not ideal because organs typically were damaged by a lack of oxygen. Organs from donors who experienced “brain death” became preferable because they could be protected better from ischemic damage. In the face of a growing demand for organs, particularly kidneys, unaccompanied by a growing number of eligible and willing donors, attention turned once again to people who are declared dead using cardiorespiratory criteria as organ donors in the 1990s. These donors, sometimes called DCD donors (donation after cardiac or circulatory death) or NHBDs (non-heart-beating organ donors) or DCDD (donation after circulatory determination of death) donors, typically donate kidneys. In some cases liver and lungs, and rarely hearts, have been used.

Donation after cardiac death includes planned or controlled donations as well as what are called uncontrolled (uDCD) or rapid organ recovery (ROR) donations. In neither case do donors meet the criteria for being declared dead using neurological criteria. Controlled DCD involves a person on a ventilator who has chosen (typically through an advance directive or surrogate decision maker) to discontinue life-sustaining measures and has a do-not-resuscitate order. The expectation is that the patient will die subsequent to the removal of ventilator support. DCD donation typically involves removal of the ventilator in the operating room after the patient has been prepared for surgery to remove organs after death, that is, after the cessation of cardiorespiratory function. Variations in practice exist within and among nations, including the amount of time after which the heart stops that death is declared (Dhanani et al. 2012). Patients who do not die within a speciﬁed time frame do not become donors. In some cases, they may continue to live without ventilator support. In other cases, their deaths come after organs have experienced too much ischemic damage to be suitable for transplantation.

Controversy followed after several infants donated hearts subsequent to being declared dead using cardiorespiratory criteria at Denver Children’s Hospital in Denver, Colorado, USA (Boucek et al. 2008). Much of the controversy concerned the question of whether or not the donors were dead before their hearts were removed. In part the debate turned on the amount of time between the cessation of the heartbeat and respiration and removal of the organs. In some cases, the infants were declared dead and organ removal began after only 75 s. The debate also involved the deﬁnition of cardiorespiratory death that is used in Colorado and some version of which is used in all 50 states in the USA. A person may be declared dead using cardiorespiratory criteria when the patient experiences the irreversible cessation of circulation and respiration. If a patient is declared dead because his heart has stopped irreversibly but the heart then is restarted, albeit in a different body, is it true that the heart has stopped irreversibly and hence that the person has met the criteria to be declared dead before the organs are removed? If the patient is declared dead before one is certain that auto-resuscitation is impossible, can we be certain that the circulator and respirator functions have stopped irreversibly? If the patient is declared dead in a time frame during which, under other circumstances, attempts would be made (sometimes, though certainly not always successfully) to restore circulatory and respirator function using advanced medical technology, are we justiﬁed in saying that the circulatory and respiratory functions have ceased irreversibly? The relationship between irreversibility and permanence was the focus of many of these discussions. Proponents of DCD held that the donors were dead and opponents questioned the claim.

In uncontrolled donation after cardiac death, a person is declared dead using cardiorespiratory criteria. Because the death was not anticipated, the decedent is not in the operating room already prepared for organ removal surgery. Instead, the person may die in the emergency room or in an ambulance after a failed resuscitation attempt, for example. It might not be known at that time whether the person wanted to be a donor or whether the family will agree to organ donation. Organ preservation measures are initiated in the event that the decedent will be a donor. These measures can involve invasive techniques, such as inserting catheters in the femoral artery and vein to ﬁll the abdominal cavity with cooling ﬂuid, extracorporeal membrane oxygenation, chest compressions to maintain circulation, and intubation to establish ventilation (Verheijde et al. 2009; Light 2008).

Programs involving uDCD have been attempted in several countries, including Spain, France, and the USA. Washington, DC, implemented an uncontrolled donation after cardiac death pilot program in the mid-1990s (Light 2008).

Both types of donation after cardiac death raise ethical issues. A central question is whether donors are dead at the time organs are removed. In controlled donation after cardiac death, questions also emerge about the permissibility of interventions, primarily the administration of anticoagulants, done to the future donor for the beneﬁt of the recipient prior to the donor’s death (DuBois et al. 2007). In uncontrolled DCD, additional questions include whether it is permissible to presume consent for organ preservation interventions before assessing donor status (Verheijde et al. 2009). Some have argued that this is not the kind of intervention for which presumed consent is reasonable, while others argue that these measures should be taken to preserve the opportunity to donate organs should it become known that a person wanted to be a donor or had expressed a willingness to donate. Special concerns emerge in uncontrolled donation after cardiac death because new resuscitation techniques might be effective in resuscitating patients who previously would have died. What was once an irreversible cessation of cardiorespiratory function might no longer be irreversible. Some of the organ preservation measures (such as ECMO) that are used restore circulatory and respiratory functions, albeit mechanically, in a way that challenges the use of cardiorespiratory criteria to declare death. In some cases, pharmacological agents are used to suppress cardiac and neurological functions that sometimes return when advanced organ preservation techniques are implemented (Verheijde et al. 2009).

Balancing the interests of ensuring donor is dead (waiting long enough after cardiac arrest) and an interest in maximizing possible beneﬁt to the recipient (minimizing damage to the organs by minimizing wait time) involves important value judgments. These competing interests as well as the interest of other parties, such as transplant organizations, transplant professionals, and medical institutions raise concerns about potential conﬂicts of interest in organ transplantation decisions and decisions about declaring potential donors dead (Verheijde et al. 2009).

Living Donors

With the growing number of people waiting for organs, especially kidneys, there has been a growing call for the use of living donors. Living donors may donate one organ from a paired set of organs (kidneys) or a portion of an organ that can function even if part of it is removed (a lobe of the liver or lung). Living kidney donation is more common and less risky to donors than living liver or lung donation. Outcomes for kidney recipients overall are better with kidneys from living donors than from deceased donors (Rudge et al. 2012). In some countries there are now more living donors than cadaveric donors, and in many cases people are not listed for kidney transplant unless they are unable to ﬁnd a living donor.

Living kidney transplantation is not new; the ﬁrst successful organ transplant involved transplanting a kidney from one living identical twin to the other. Transplantation using organs from cadavers became the favored approach for all organs in part because it avoided important ethical issues raised by living organ donation, most notably that the practice puts a healthy person at risk for possible beneﬁt to the recipient. As the number of organs available from cadavers failed to keep up with demand, attention once again turned to living donation. In addition to kidneys, attempts to use living donors for liver and lung transplantation began. Early living liver donation typically involved parents donating a lobe of their liver to a child, with the ﬁrst successful transplant in 1989 and the ﬁrst adult-to-adult living liver transplantation in 1994 in Japan. Living lung donation is uncommon and involves two donors, one lobe from each. Pancreas and small bowel living donations are even less common.

In addition to concerns about the risks to donors, living organ donation raises other ethical questions. For example, what, if anything, are donors owed? Who should cover the costs donors might face if they experience complications from their donation surgery? Is there ever an obligation to donate? What should be done to protect relatives who do not want to donate but are afraid to refuse? What information should be shared with potential donors and how? How much risk to donors is acceptable? To what extent must the voluntariness of donors be protected? For whom should individuals be allowed to put themselves to risk? A number of concerns emerge regarding pressure to donate, how much risks donors may be exposed to for the beneﬁt of another person, and compensation or incentives to donate.

Special concerns emerge when the potential donor is a minor. Many jurisdictions prohibit minors from donating solid organs or allow it only under very limited circumstances.

Although initially living donation was done among relatives, there are now many types of living donors. These include blood relatives, emotionally related individuals (such as friends, coworkers), nondirected (altruistic), paired or chain, waiting list exchange. Some involve a combination of donors, for example, a nondirected donation can start a chain donation wherein one recipient has a willing, incompatible donor and the altruistic donor is a match. The altruistic donor gives a kidney and the recipient’s willing, incompatible donor gives a kidney to someone else who has a willing, incompatible donor and so on.

Consent For Organ Donation

Organ donation systems may be governed by an opt-out (presumed consent) or opt-in (actual consent) policy for deceased donors. There are variations within each.

In a presumed consent or opt-out system, it is assumed that decedents were willing to donate their organs unless they had listed themselves in a non-donor registry or communicated their non-donor status in some other accepted way. One variation among such systems is whether or not transplant professionals ask the decedent’s family for permission to remove organs, particularly if there was no clearly expressed wish to be a donor. A presumed consent system might not require family permission, but professionals nevertheless might ask for permission in practice. Some object to presumed consent on the grounds that it disrespects persons and violates personal autonomy or the authority of individuals and families. Countries with presumed consent laws include Spain, Belgium, and Austria, among others. Cultural factors affect the acceptability of a presumed consent approach. For example, the USA has not pursued presumed consent out of concern that it would decrease trust in the organ donation system and decrease donation rates. In other settings, presumed consent has been acceptable and increased donation rates.

In an opt-in or actual consent system, to be donors, decedents must have signed a donor card or listed themselves in a donor registry or their family must give permission for organ donation. Japan, the USA, and Canada are among the countries with an opt-in system. Even with an expressed willingness to donate, family members might still play a role in donation decisions. In an opt-in system, many people who are not listed on a donor registry or have not signed a donor card or driver’s license are eligible to donate if family members agree to organ donation. Organ transplant advocates have made signiﬁcant efforts to identify practices that maximize consent rates. For example, physicians taking care of a patient who might become eligible to donate could be required to notify organ transplant professionals, who then can review medical records and speak with the patient’s family. Additionally, the use of people who are trained to request permission for donation and who use carefully chosen language to lead families to donate have been praised by some and criticized by others for undermining free and voluntary informed consent (Truog 2008). Some scholars have questioned these practices insofar as they are designed not to promote free and voluntary informed consent but rather to promote organ donation.

Presumed consent also is important in discussions of uncontrolled donation after cardiac death. In these scenarios, organ preservation techniques must be implemented immediately, ordinarily before a person’s donor status can be assessed by consulting the family or reviewing donor registries. In some cases, a driver’s license or donor card found on the person might indicate their status, but often this will not be the case. There is significant disagreement about the permissibility of presuming consent for initiating invasive organ preservation techniques. Some argue that this violates respect for autonomy because it imposes interventions on decedents who did not give prior consent for these interventions and whose families have not given permission for the interventions.

Others maintain that it respects autonomy by making it possible to respect previous organ donation decisions when they become known and protect a family’s ability to allow a decedent to become a donor (Verheijde et al. 2009).

Living donors typically must give individual informed consent. Despite efforts to ensure that consent is free and voluntary, some donors report family pressure to donate or not to donate. Concerns about voluntariness also emerge in the debate about ﬁnancial incentives or payments to organ donors (see below).

Exchanging Organs For Organs Or For Money

With very limited exceptions, the sale of organs for transplantation is prohibited. Exceptions include Iran and the Philippines which have provisions allowing some organ sales when the donors and recipients are Iranian or Filipino, respectively. Living donors may not be offered ﬁnancial incentives or payment to donate organs and families of deceased donors may not be paid or given other ﬁnancial incentives to donate (Rudge et al. 2012).

There has been much discussion about whether ﬁnancial incentives would increase the donation rates and whether they would compromise voluntariness or even coerce donors/families. Many object to ﬁnancial incentives on grounds that individuals might be coerced or feel undue pressure to sell an organ, that the poor will be exploited, that it is wrong to treat body parts as commodities, and that it is wrong to pay people to expose themselves to risk, among other reasons. Others defend some form of ﬁnancial incentives, arguing that a well-regulated market for human organs could dramatically reduce the kidney shortage, that people routinely are paid to expose themselves to risk and if the risks of being a living donor are low enough to face for free then they are low enough to face for money, and that people have authority over their bodies, among other reasons.

While the debate about exchanging organs for money continues, a different form of exchange has become widely accepted. The standard approach to living donation involves two people, one donor, person A, who often is a relative or “emotionally related” (e.g., friend) and one recipient, person B. Person A donates a kidney or part of a liver or lung to B. However, paired exchanges, chain exchanges, and waiting list exchanges raise questions about whether in fact donors are receiving “valuable consideration,” the term used in the US law prohibits the sale of organs. In all of these cases, the donor donates so that someone they want to help gets help, either in the form of a needed organ or a higher place on the waiting list. Were it not for the beneﬁt they will receive in exchange for their donation, they would not donate. Although it does not involve the exchange of money, it does involve the exchange of goods that people consider valuable. This raises questions about why this kind of exchange is permissible but the exchange of an organ for money is prohibited.

There has been much discussion in recent years about organ trafﬁcking and transplant tourism. Typically this practice involves individuals from developed nations traveling to poor countries to purchase an organ and receive a transplant. One of the main objections to this practice is the concern that poor and vulnerable people are being taken advantage of for the beneﬁt of the well-off. Some observers defend the practice citing the possibility for economic advancement, but others argue that often this does not work out for vendors. In addition to loss of an organ, they might have poor follow-up care and suffer long-term health problems. Transplant professionals may ﬁnd themselves caring for patients who have received transplants from organ vendors in other countries and return home. Those recipients, like all transplant patients, need long-term follow-up care. Many of the circumstances of the transplant, the source of the organ, and the surgery itself may be unknown, leaving physicians in patients’ home countries at a disadvantage in caring for them. Some might feel complicit in an activity they ﬁnd problematic.

Culture, Religion, And Organ Transplantation

Attitudes regarding organ donation vary within and among cultures and religious groups. In some cases, these differences lead to competing accounts of who should give consent for organ donation. For example, in some cultures the role of the family may be so important that organ donation cannot proceed from a deceased donor without family permission. Even someone who indicated a desire to donate would not become a donor without the family’s approval. In some cases, there are cultural or religious beliefs that pose obstacles to organ donation. For example, Japan adopted legal criteria for declaring death using neurological criteria long after many other developed nations did, and brain death is not widely accepted in Japan. Insofar as death determined using neurological criteria is not recognized as death, many patients who could become donors in other settings cannot donate (Asai et al. 2012). In China, low organ donation rates often have been blamed on traditional Chinese cultural perspectives, most notably Confucianism, Buddhism, and Taoism. Some scholars challenge interpretations of these traditional views that lead people to reject organ donation (Cai 2013).

Efforts to increase donation rates may have important cultural or religious components. For example, in Israel priority to receive an organ may go to patients who also have indicated a willingness to donate organs. While some hold that this is fair, others object because it disadvantages ultraorthodox Jews who are willing to receive organs but not to donate because they reject brain death.

Allocation Of Organs

Many of the ethical issues associated with organ transplantation concern donors and potential donors. A number of important ethical questions emerge on the recipient side. These include questions regarding who may be listed on the transplant waiting list and how available organs are to be allocated. Jurisdictions have different mechanisms for allocating organs, but these typically include a system for matching available organs with recipients. Considerations often include blood type and histocompatibility, the size of the organ, time the donor has been on the waiting list, the urgency of the recipient’s medical need, and donor and recipient’s geographical locations. Criteria vary from organ to organ, and often the policies for children are different from adult policies.

Determining criteria for allocation organs involves ethical, not only medical, judgments. These include judgments about prioritizing people based on age or geographical location. Different allocation plans will advantage and disadvantage different groups, and deciding whose needs to prioritize and to whose detriment is an ethical decision. A number of countries have developed mechanism for prioritizing recipients using additional criteria. For example, in Japan family members in need of an organ may have priority over others to receive a decedent’s organs. In Israel, people who have indicated that they are willing to donate their organs may be prioritized over individuals in need of an organ who have not indicated a willingness to donate.

Xenotransplantation

Several cases of xenotransplantation, transplanting organs between species, have been reported (Cooper 2012). One of the most well-known cases is the transplant of a baboon heart into a human infant, Baby Fae, whose body rejected the organ and she died 20 days post-transplant. Most efforts to transplant animal organs into humans have been unsuccessful, though research to genetically engineer pigs so that their tissues are less likely to be rejected by the human immune system continues.

Xenotransplantation raises numerous ethical questions. These include questions about the permissibility of killing animals to procure organs, particularly animals such as baboons that are not typically killed as food sources, and risks to recipients.

Regenerative Medicine And Bioengineering

Many experts believe that regenerative medicine and bioengineering will provide the ultimate solutions to key problems associated with organ transplantation, namely, rejection and the fact that the demand for organs exceeds the supply. If successful and affordable, bioengineered organs could dramatically decrease or eliminate the waiting list for organs and avoid the need for immunosuppression in recipients. Success in this area thus far has been limited the hollow organs, such as the bladder. Bioengineered complex modular organs, such as the liver, lung, and heart, pose more signiﬁcant challenges and are still being investigated (Orlando et al. 2013).

Conclusion

Organ transplantation raises a wide range of ethical issues regarding both donors and recipients. These range from disputes about deﬁning and determining death to the allocation of scarce organs and would be irrelevant if organs could be bioengineered safely, effectively, and affordably.

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