A 53-year-old single mother offers to donate a kidney to a work colleague whom she knows distantly. Although the recovery time needed away from work after donation will strain her modest income, the woman tells the transplant team that she understands this and is willing to go ahead. She explains that her motivation to donate is purely to help another human being.
A man involved in a serious road traffic accident has suffered severe injuries and has been placed on life support while investigations are completed. The results indicate he will not survive. His relatives are not present at the hospital. The junior physician treating the patient considers withdrawing supportive treatment. He wonders whether the patient would be a candidate for non-heart-beating donation after cardiac death is pronounced.
Organ transplantation is both a life-extending and a life-saving medical procedure in which a whole or partial organ (or cells in cell therapy) from a deceased or living person is transplanted into another individual, replacing the recipient’s non-functioning organ with the donor’s functioning organ. Advances in the science of organ transplantation since the 1980s have significantly broadened the range of transplantable organs and improved transplant outcomes. Transplant centers in different parts of the world successfully transplant kidneys, livers, lungs, hearts, pancreases, and intestinal organs, and the procedure is considered the preferred treatment for several indications. Since the first kidney transplant in 1954, the increasing success of, and innovations in, transplantation have created a demand for organs that greatly exceeds the supply in most countries.
The scarcity of organs is a major impetus behind the continuing search for, and development of, alternative ways to expand the pool of organs and tissues available for transplantation (O’Connor and Delmonico, 2005). A major development is the procurement of organs from family members, and most recently from friends and even from strangers (Matas et al., 2000; Gohh et al., 2001; Hilhorst et al., 2005). We are also witnessing desperate patients soliciting organs on the Internet (Wright and Campbell, 2006), the compensation of living donors for related expenses or even the bestowing of financial rewards for donation (Larijani et al., 2004), and the experimental use of organs from animals (i.e., xenotransplantation; Daar and Chapman, 2004). These recent trends are at the forefront of current ethical debate on transplantation, and they are gaining varying levels of acceptance in different countries by both the public and the transplant community. The sale of organs is another highly complex subject that has received much attention (Radcliffe-Richards et al., 1998; Phadke and Anandh, 2002; Taylor, 2002; Daar, 2003, 2004a).
Organ transplantation presents several ethical challenges. Amongst these are issues related to the determination of death, organ procurement, and organ allocation (Veatch, 2000). Definitions of death attempt to establish the point at which a person’s loss of critical bodily functions alters his or her status from living to dead (Lazar et al., 2001) and therefore when, in the context of transplantation, it is morally acceptable to procure organs from the deceased. There is now widespread acceptance, especially among intensivists and the transplant community, but with much public support in many countries, of brain death criteria for diagnosing death (US President’s Commission, 1981; Dossetor and Daar, 2001). Some cultures do not accept this, preferring instead the traditional definition of death as the irreversible cessation of cardiorespiratory functions. These different perspectives obviously influence the formulation of legal and medical criteria for the posthumous procurement of organs.
One of the questions being debated is whether, after death, an individual’s organs are a societal resource to be automatically recovered or an individual’s personal property, requiring his or her approval to organ recovery (Truog, 2005). The vast majority maintain that organs belong to the potential donor and thus the most prevalent deceased donation model requires a person’s consent to donate through signing a donor card while alive, or more commonly, through the agency and consent of next-of-kin, after death. This model is based on respect for individual autonomy (Veatch, 2000). The practice of obtaining consent to donation of deceased organs from a substitute decision maker raises, for some people, ethical concerns about presuming another’s wishes if the subject of donation had not been discussed with the deceased while he or she was alive (Veatch, 2004).
A variation of this model is what is known as presumed consent (Kennedy et al., 1998), which permits the removal of organs unless the person has formally opposed it while living. This model emphasizes the greatest net benefit for society (Veatch, 2000), but apart from a few European countries, it has not been successfully adopted and implemented internationally.
Organ procurement from the living is more accepted in some parts of the world than others. Donation is assessed by weighing the benefit to the recipient against the physical harm and psychological benefit to the donor (Matas et al., 2000). Many agree that a donation between relatives is ethical because the familial relationship appears to justify the risks involved. Some, however, have expressed reservations about the propriety of living donation from non-family members, and especially from strangers. They argue that, in the absence of a genetic or emotional link between the donor and recipient, the donor’s motives are more questionable or that the psychological benefit of donation does not justify the physical risks. However, altruism is an acceptable basis for living donation, and some argue that altruism is foremost expressed through donation to non-relatives and strangers than to relatives (Evans, 1989; Daar, 2002). Some further contend that, because a stranger’s offer to donate is altruistically motivated, there is a greater chance that he or she is acting autonomously and in the absence of undue external pressure to donate (Gohh et al., 2001). The debate continues as to whether strangers should be allowed to assume the same level of risk as other living donors when being considered for donation (Abecassis et al., 2000; Spital, 2002; Daar, 2002; Ross et al., 2002).
The scarcity of organs for transplantation necessitates the establishment of criteria on which to base allocation decisions, particularly for organs from deceased donors. The distribution formula commonly used draws mainly on two general ethical principles: utility and justice (Veatch, 2000). Utility is calculated according to medical benefit and justice is assessed on the equity of distribution, requiring (on some accounts) that the sickest or worst off be given some priority to ensure that all are afforded an equal chance to be healthy (Veatch, 2000). Many allocation decisions require trade offs in favor of either utility or justice, and thus attempt an acceptable compromise.
The laws enacted to regulate organ transplantation vary with jurisdictions around the world. They generally cater to definitions of death, donor consent, and, often, the prohibition of the commercial trade in organs. The laws in most North American, Asian, and European countries permit organ removal when the patient is pronounced dead. These laws most commonly define death as the irreversible cessation of the entire brain function, although Japanese law allows the individual while living to choose between the cardiac- and brain-based definitions of death according to his or her beliefs (Morioka, 2001; Bagheri, 2005).
The laws in most countries require donor consent to posthumous organ donation. The Uniform Anatomical Gift Act (USA) and the Human Tissue Gift Act (Canada) each require an individual’s express consent to the removal of his or her organs after death. “Opt-in” donor consent is common internationally. In contrast, the laws in some European countries (Kennedy et al., 1998; Abadie and Gay, 2006), and with rare exception elsewhere, as in Singapore (Schmidt and Lim, 2004), allow the procurement of organs based on presumed consent, but permit individuals to “opt-out” of donation. Japanese law does not allow for a substitute decision maker but requires both a signed donor card and family approval of organ removal (Bagheri, 2005). Internationally, transplantation laws generally permit the removal of organs from a living individual with his or her consent.
Many countries have enacted legislation against commerce in organs. Partly as a result of these legal prohibitions, the phenomenon of transplant tourism has emerged (Daar, 2004a). In India, for example, the sale of organs is illegal but the legislation established to prevent it has proven ineffective (Daar, 2004a; Young, 2005), and the practice apparently continues to flourish, with some foreigners traveling to India to buy kidneys for transplantation. China has recently pledged to outlaw the sale of organs from executed prisoners in an attempt to eliminate a widely criticized market in human organs (BBC News, 2006).
Unlike payment for organs, the compensation for expenses incurred by donation is considered completely justified. Genuine compensation is allowed in most countries, although there has been little work done to define acceptable limits of reimbursement and, more importantly, to develop schemes to reduce disincentives to donation. The US law grants a 30-day paid leave of absence to federal employees for organ transplantation (Delmonico et al., 2002). Iran is the only country so far that has openly institutionalized the formal payment of donors. The Iranian model, which gives money to kidney donors as a social reward, is still evolving. Although it has been criticized, the model has resulted in Iran completely eliminating its kidney transplant waiting list (Gohds and Nasrollahzadeh, 2005).
Government agencies, transplant regulatory bodies, and healthcare institutions recommend and set policies that, in addition to legislation, guide transplant practice with respect to definitions of death, allocation decisions, and organ precurement. Despite the widely adopted legal definition of brain death, individual hospitals have varying practices used by physicians to certify death. It would be advisable to have uniformity (Powner et al., 2004).
Organs from the deceased are commonly allocated according to policies established by regional, national, or international transplant organizations. In Canada, the Trillium Gift of Life Network and the British Columbia Transplant Society are among the largest regional organizations handling the collaborative development and implementation of policies governing organ distribution. Policy management is undertaken in the USA by a national organization, the United Network for Organ Sharing, and in several European countries by an international organization, the Eurotransplant International Foundation. Generally, these transplant organizations use computer programs to allocate organs to recipients on a waiting list, and position recipients on the list based on acceptable criteria such as organ compatibility, medical need, wait time, and geographical distance between the organ and the recipient (British Columbia Transplant Society, Eurotransplant International Foundation, Trillium Gift of Life Network, and the United Network for Organ Sharing).
Policies on living donation at most transplant centers support donations from relatives. Donations from friends and altruistic strangers are increasingly being accepted. Although policies allow donors to direct their organ to a known recipient, transplant centers that permit donations from altruistic strangers, in which the recipient is unknown, are reluctant to allow such donors to direct organs to a recipient of a specific social group (Matas et al., 2000). Instead the recipient is selected according to the same waiting list criteria as for deceased donor organs (Hilhorst et al., 2005).
At a conference in Munich in 2002 (Warren, 2003), the following resolution was passed on the complex issue of payments related to transplantation:
The well-established position of transplantation societies against commerce in organs has not been effective in stopping the rapid growth of such transplants around the world. Individual countries will need to study alternative, locally relevant models, considered ethical in their societies, which would increase the number of transplants, protect and respect the donor, and reduce the likelihood of rampant, unregulated commerce.
A 2001 study indicated that a significant percentage of Americans surveyed found kidney donations from close friends (90%) and strangers (80%) acceptable (Spital, 2001). Related national and international social research data spanning the period from the late 1970s show that a sizeable proportion of individuals (studies vary from 11% to 45%) would be willing to donate a kidney to a stranger while living (Henderson et al., 2003). Despite general public approval of altruistic stranger donation, a noteworthy 2003 Canadian study (Landolt et al., 2003) sought to measure the relationship between people’s willingness to donate to a stranger, while living, and their actual behavior. Results indicated that of the 52 respondents who were hypothetically prepared to donate and underwent a psychosocial assessment parallel to living donors, 31% qualified as committed to donate. The study concluded that, because the respondents generally had no prior knowledge of altruistic stranger donation, some people would be candidates for this form of donation if informed about the need and given accurate information about the procedure (Landolt et al., 2003).
Several related studies have measured public opinion on the recent debate over altruistic stranger-directed donation. Results from a recent study (Spital, 2003) indicated that the majority of American respondents would not permit altruistic strangers to direct their organs to recipients on the basis of their membership in a particular racial or religious group (two-thirds), although 74% would allow directed donation to children. The study conclude that current local and national policies against altruistic stranger-directed donation are rightly aligned with public views, although some raise concerns about using the general public’s attitudes to determine policy (Hilhorst, 2005).
Public acceptance of xenotransplantation, or the transplantation of organs, cells, or tissues from animals into humans, has been empirically evaluated. A 2004 study (Rios et al., 2004) indicated that, if animal organs had similar results to human organs, 74% of American respondents would accept the use of animal organs and, when compared with all organ donation options, it was the favored option. In Canada, an exemplary government-sponsored public consultation on xenotransplantation (Canadian Public Health Association, 2001) found that of the most informed participants, 34% did not want xenotransplantation to proceed under any conditions; 19% indicated that it was too soon; and 46% were in favor of proceeding if safe and effective. The study resulted in the government recommending that Canada “not proceed with xenotransplantation involving humans at this time as there are critical issues that first need to be resolved” (Canadian Public Health Association, 2001). Despite this verdict, some argue that a different rendering of the study’s data reveals more favorable attitudes toward proceeding with xenotransplantation (Wright, 2004).
Practice guidelines for deceased donation, in instances in which a person’s death is expected but has not yet occurred, urge that declarations of death or the decision to withdraw life support be made by a physician who is not a member of the transplant team and before approaching the family about donation. Usually, the family is given information about the option to donate and the possible outcomes, is asked about the patient’s intention to donate, if known, and is asked to give consent to such donation. These tasks are often handled by regional organ procurement agencies, which upon being notified of a potential donor by the transplant center, find a suitable recipient and coordinate the recovery and transportation of organs (United Network for Organ Sharing).
Consensus statements and recommended ethical practice guidelines on living donation identify several practical elements as essential to ensuring the well-being of living donors. With respect to informed consent, a donor must be fully and accurately informed about, and demonstrate an understanding of, the risks and benefits of donation as it affects themselves and the recipient (Abecassis et al., 2000; Ethics Committee of the Transplantation Society, 2004; Wright et al., 2004; Zink, 2005), as well as the different treatment options available to the recipient. A period of time between consent and the operation is recommended, during which the donor has an opportunity to reconsider his or her decision. The transplant center must ensure that the donor’s decision to donate is voluntary and is not influenced unduly by material gain, coercion, or other factors that may reduce individual autonomy. It is recommended that, if possible, the donor and the recipient be assigned separate care teams or advocates to protect their individual interests (Abecassis et al., 2000; Ethics Committee of the Transplantation Society, 2004; Wright et al., 2004), as well as to enhance confidentiality and avoid conflicts of interest.
Assessments of medical suitability will depend on which organ is being donated and will be carried out by the transplant team physicians. The donor’s psychosocial suitability must be evaluated to rule out psychological risk factors such as severe mental disorder. It is also advisable to evaluate other factors such as economic constraints or domestic issues. These evaluations help to determine whether the donor is mentally competent to give informed consent, and if his or her decision is voluntary (Abecassis et al., 2000; Wright et al., 2004).
Altruistic stranger donation should follow the same guidelines as those established for donations from relatives, with an emphasis on the psychosocial assessment. In addition, the relationship between the donor and recipient, whether strangers or familial, should not affect the degree of acceptable risk to the donor (Abecassis et al., 2000).
It would be useful to have transplant unit policies on living donations from non-relatives, especially as they are becoming increasingly common. In the first case, the transplant unit must balance the need to explore ulterior motives such as covert payments with the need to respond to a genuinely altruistically motivated donor. A psychosocial evaluation, preferably by an independent expert in living organ donation, is usually administered, but it is difficult to establish ulterior motives. In addition, transplant units cannot control the exchange of material rewards or other events that may transpire after a transplant is completed. These are also matters of concerns in donations from relatives.
The transplant center planned ahead to ensure that the donor had sufficient support, including legitimate financial support, during her recovery from the operation. The recipient was a distant work colleague, which made this, in the absence of any coercion, a truly altruistic donation. The donor was fully informed about, and understood, the risks and benefits of her donation, and the donation process. The transplant team concluded that the woman was a willing, informed, altruistically motivated individual, wishing to donate for rational reasons that were important to her, and she was, therefore, a suitable donor.
If there is consensus that non-heart-beating donation should be undertaken in the second case described, it should be done exclusively at institutions with clearly established protocols. The Maastricht classification divides the five donation types into uncontrolled and controlled groups depending on whether cardiac death was anticipated (Ridley et al., 2005). Several decisions must be made under emergency conditions when a patient is brought in either dead according to cardiopulmonary criteria (uncontrolled) or is in extremis with no hope for survival (controlled). In the controlled group (as in this patient), if the patient’s relatives are not present, should preparation for organ retrieval proceed while they are sought? This usually takes the form of cooling the organs and may involve administering drugs to protect the organs, neither of which will benefit the injured and dying patient. If the relatives cannot be contacted, should organ retrieval proceed? These pressing issues are currently being explored with much interest at many centers.
If the relatives are present, there are minor differences in the consent procedures used currently in standard practice in which the potential donor is pronounced dead according to neurological criteria (i.e., brain death). In fact, deceased organ transplantation originally started with donation after cardiac death, not by applying brain death criteria, which entered transplant practice later. Brain death criteria continue, in some places, to be controversial.
If the heart is still beating, another question arises, based on the tension between a desire to confirm death absolutely and the desire to obtain organs that have not been damaged by ischemia: how long should the surgeon wait after the heart has stopped, following withdrawal of life support, before removing the organs (Daar, 2004b)? In this case, the relatives were found quickly and they consented first to withdrawal of life support and later to donation only of the kidneys. The physicians proceeded to cool the kidneys via an abdominal catheter but chose not to administer any drugs to help to preserve them. The patient was taken to the operating theatre, life support was withdrawn (Maastricht type 3), and the surgeon waited a full 10 minutes before removing the kidneys, which were offered to two recipients with their full knowledge that the kidneys came from a non-heart-beating donor. One kidney functioned straight away, while the other had mild ischemic damage but began functioning well three days later. Both recipients are alive with functioning kidneys four years later.