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Transplantation: ethical and legal considerations
ETHICS
a distinction between the body and the patient. However, a family regards their relative’s body as having value and this must be respected. Diagnosing brainstem death provides an important demarcation between therapeutic medical care for the patient and the involvement of the transplant team. It must be stressed that the establishment and acceptance of brainstem death criteria were separate and unrelated to the introduction of transplantation techniques, although they were closely related in time. Some cultures do not accept brainstem death criteria, mainly because certain beliefs about death make it difficult to equate brainstem death with actual death. Furthermore, the number of heart-beating donors is declining. This is because fewer young people are dying as a result of an accident or cerebrovascular event, whilst there have been improvements in the diagnosis and management of severe brain injuries, leading to fewer patients fulfilling brainstem death criteria. Thus, other means of obtaining organs suitable for transplantation need to be considered.
Transplantation: ethical and legal considerations Nick Pace
The first successful human kidney transplant took place in 1954, thereby establishing one of the great medical innovations and advancements of modern time. However, new ethical dilemmas were introduced into medicine at the same time. As transplantation becomes more complex, these ethical dilemmas are becoming more acute, especially as the techniques are now well established. Indeed, it would be impossible to fully discuss these dilemmas in the limited space available here. This article highlights some recent developments and should be read in conjunction with Anaesthesia and Intensive Care Medicine 4:5:162. A successful transplant leads to an improved duration and quality of life for the recipient, and in many cases it can be life saving. Furthermore, outcomes continue to improve, and currently approximately 90% of recipients are alive and well 1 year after transplant. However, the scarcity of suitable organs means that not all those requiring an organ can receive one. Because demand far exceeds supply, an ever-widening gap is created. Most of the ethical concerns relate to this discrepancy, with the shortage of donor organs being the biggest problem facing transplant programmes. Furthermore, the success of long-term replacement therapy has created growing waiting lists for renal transplantation. Unfortunately, such an option is not available to patients needing heart, lung or liver transplants, and in these cases an urgent or sometimes emergency operation is required. There were 6545 patients on the waiting list for an organ transplant on 1st January 2006. Recent data suggest that more than 400 of these patients will die each year before an organ becomes available. In the past 9 months, 1717 patients received an organ, while 592 donated (www.uktransplant.org.uk).
Non-heart-beating organ donors Before the establishment of brainstem death criteria, organs were obtained from cadavers whose heart had stopped; so called nonheart-beating organ donation. The fundamental problem with this was poor organ function due to warm ischaemia damage. However, recent advances in organ protection, immunosuppression and surgical techniques have led to renewed interest in obtaining organs from such donors. Indeed, the 1-year and 5-year kidney transplant results are similar whether the kidney was obtained from a brainstem dead cadaver or a non-heart-beating organ donor. Thus, the latter can no longer be dismissed on the grounds of organ viability, and there are suggestions that increased use (currently these donors contribute only 3% of transplanted organs) could increase organ availability by up to 20%, thereby making a major contribution to waiting list reduction. However, more successful outcomes will ensue only if strategies can be devised to keep warm ischaemia times as short as possible. In all cases, declaration of death occurs after the cessation of circulation and respiratory function. In 1995 the Maastricht classification identified four categories of potential donors (Figure 1). A fifth category has recently been suggested to identify a more specific group: unexpected cardiac arrest in a patient in ICU. Categories 1, 2, 4 and 5 have been described as ‘uncontrolled’ donation. All preparations for retrieval have to take place from the time of death and be completed before the maximum recommended warm ischaemia time of 45 minutes has been reached. These preparations include addressing issues of consent, counselling relatives, preparation of the donor (tissue typing, viral status), mobilizing a surgical team, and finally cold perfusion of the organs. The anaesthetist on the arrest team in the ward, on stand-by in the accident and emergency department or, more significantly, at an unexpected arrest in an ICU patient could be involved in the declaration of death and notification of the transplant team. Category 3 is a controlled donation. Category 4 can also occasionally be considered a controlled donation, depending how far along the process has progressed when the patient arrests. These patients are generally more stable, their condition is deemed to be futile, and a decision to not introduce care or to withdraw care has been made. Asystole and cardiac arrest are thus predicted and expected. The preparations mentioned above can be made before death occurs and organ retrieval can be scheduled. This makes it easier
Organ supply Cadaveric Currently, in the UK, most organs are supplied from cadaveric donors in whom brainstem death has been confirmed and, therefore, whose hearts are still beating. The maintenance of ventilation and circulatory support allows time for discussions with relatives, potential donor screening, and a more controlled approach to organ retrieval, with short warm ischaemia times. How we should care for the body after death is fundamental to discussions regarding organ supply. Some would argue that there is
Nick Pace is Consultant Anaesthetist at the Western Infirmary, Glasgow. He trained in Glasgow, Cardiff, Riyadh and Dallas. His main interests are anaesthesia for renal and endocrine diseases, transplantation and trauma. He has masters and doctorate degrees in medical law and ethics.
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contentious issue and reflects the author’s personal belief. Recent legal advice may support this view; however, it is contrary to that of the Intensive Care Society, which rightly takes a conservative approach. All would agree that it would certainly be inappropriate to use such drugs if they could potentially accelerate the patient’s death (e.g. significant risk of catastrophic haemorrhage if heparin were given). The use of these drugs should be explained to the relatives when consent is being obtained (an issue that will be discussed later). Third, the use of aorto-femoral cannulation can be problematic. Perfusion with cold preservative can be used to maintain organ viability, buying time to allow a more relaxed surgical retrieval. This can be very useful in uncontrolled donation, but with controlled donation there could be problems with obtaining consent. Fourth, and probably most importantly, there are difficulties with the confirmation and certification of death. The traditional loose definitions and timings of cardiac death are challenged by non-heartbeating donation. For example, what is the legal definition of death? Cardiorespiratory cessation and brain death are not identical. Some protocols are vague with regard to how death is determined and at which point organ preservation and retrieval can be undertaken. In practice, the patient is deemed to be dead if they are not hypothermic and are irreversibly unresponsive, apnoeic and asystolic. However, the moment of arrest is not irreversible and there is no consensus on how much time must pass after cardiac arrest before death becomes irreversible. Although without resuscitation apnoea and asystole are taken to be irreversible after 2 minutes, permanent loss of brain function may take a lot longer. Since there is no method to determine when loss of brain function is irreversible, it seems appropriate to wait for a period of time that would put this beyond doubt. However, dfferent groups use different times and this would have to be discussed and agreed at local level. Most groups agree that confirmation and certification of death should be undertaken a minimum of 5 minutes after cardiorespiratory arrest. Early discussions with local authorities that deal with and investigate deaths, such as coroners, procurators fiscal and the police, are essential before the introduction of any protocol.
Categories of non-heart-beating donors Category 1 Dead on arrival at hospital: patients who suffer an out-of-hospital arrest and arrive in hospital with an accurate documentation of the time of death and pre-hospital resuscitation Category 2 Unsuccessful resuscitation: patients who arrest in hospital and have an accurately documented failed resuscitation attempt Category 3 Awaiting cardiac arrest: patients who present to the accident and emergency department with a non-survivable injury, or those in a general or neurosurgical ICU whose death is inevitable. They do not fulfil brainstem death criteria and therefore cannot become a heart-beating donor Category 4 Cardiac arrest in a heart-beating donor: patients whose death has been confirmed by brainstem testing but arrest before organ retrieval can take place 1
to minimize warm ischaemia times, and consequently the organs procured should be of a higher quality and carry a better prognosis after transplantation than organs from uncontrolled donation. The implementation of non-heart-beating organ donation would involve changes to the existing transplant framework. Controlled donation offers the best opportunity to introduce this type of donation successfully, and ICUs would be the focus for identifying potential donors. An accident and emergency programme is more difficult to introduce, especially with respect to proper resourcing, such as surgical availability. In all cases, there are several ethical and legal concerns that need further examination. Recently, the Intensive Care Society has issued guidance on the optimum management of non-heart-beating organ donation in adult critical care units. First, the decision regarding the futility of further treatment needs to be made in accordance with current guidelines, such as those produced by the British Medical Association or the General Medical Council, and deemed to be in the patient’s best interests. The timing of the whole process may be influenced by the need to ensure optimum organ viability, and thus there may be a conflict between trying to reduce warm ischaemia times and good medical care. Doctors continue to have a duty of care to the potential donor until the moment of death. To avoid any conflict of interest, the initial decision to withdraw care or to stop resuscitation in the accident and emergency department should be made on the basis of a multidisciplinary discussion, precede and be clearly separate from consideration of donation, and not involve any of the transplant team. Second, once the decision is taken to withhold or withdraw treatment, the escalation of current treatment in order to improve organ viability would be inappropriate. However, the administration of steroids, antibiotics and heparin may be used to minimize organ deterioration after death and can be justified because it may help fulfil the patient’s wish to donate organs. Please note that this is a very
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Live donation This type of donation is becoming an increasingly popular source of organs in the UK. In parts of the world that do not accept brainstem death criteria, live donation may be the only source of organs. Living donation of kidney, liver lobe or lung lobe has increased as waiting lists increase and cadaveric organs become increasingly scarce. In the UK the proportion of kidney transplants involving live donors is now approaching 25%. The benefits to the recipient are clear. They include a reduced waiting time, a scheduled procedure, which may even be undertaken pre-dialysis, a reduced cold ischaemia time and long graft survival. However, the benefits to the donor are not so clear and may be purely psychological. How does the ethical principle of ‘firstly do no harm’ sit with live donation? It is not clear whether this is an absolute position. The risks of morbidity and mortality to the donor depend on the organ or lobe donated, and thus an appropriate risk–benefit assessment needs to be undertaken. Globally, adult-toadult transplantation of the right liver lobe has a donor mortality of about 1%, while kidney donation has a mortality of 0.03%. Surprisingly, the Council of Europe has stated that organ removal from living donors must remain the exception because of the possible risks to the donor. Thus, such removal may be carried out only when there is no suitable organ available from a dead donor and 186
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there is no other alternative therapeutic method of similar effectiveness. Clearly, this position is not sustainable and indeed many EU countries, including the UK, are aiming to increase the proportion of live organ donation. However, it may be ethically appropriate to refuse an offer of an organ if the risk to the donor is too great. At the same time it is essential that other ethical principles, namely autonomy and beneficence, are considered. Indeed, the most serious concern lies with the possibility of improper pressure being applied to a donor; a point that will be returned to later when discussing consent. Other issues that arise when discussing live donation include paired exchange, domino transplants and altruistic donation.
this category could logically be extended to other patients, such as those in a persistent vegetative state, which society would find unacceptable. Elective ventilation was proposed a number of years ago. This entailed the transfer of patients in a deep irreversible coma to ICU so that they could be intubated and ventilated as soon as they suffered a respiratory arrest. Support could be continued until the patient became brainstem dead and donation would proceed in the same manner as a cadaveric donation. However, many believed that it was wrong to prolong life and alter the mode of dying for the benefit of others and the practice was deemed illegal and abandoned. Executed prisoners have been used as a source of organs in some countries for many years. Arguments abound both for and against such a practice, and depend on what ethical principle is given most importance. Although condemned by many, others argue that, given the possible benefits, not to use such organs would be immoral. Xenotransplantation is the transplantation between different species, and offers the prospect of an unlimited supply of organs. Not surprisingly, animal rights issues abound in discussions about the legitimacy of such a practice. However, although immunological problems continue to be problematic, the greatest barrier to further consideration remains the risk of trans-species infection. There would, however, be huge benefits in overcoming the shortage of organs, with ancillary benefits regarding work, premature death and cost of treatment.
Paired exchange involves a donor and recipient pair donating to, and receiving from, another donor/recipient pair to overcome ABO blood group incompatibility or histo-incompatibility. Studies in the USA and Holland have shown that this could be a very effective practice for difficult-to-match patients. However, this practice is currently not allowed in the UK because it is a form of directed conditional donation (i.e. agreement to donate is made on the basis of who will receive the donated organ). In a recent UK case involving cadaveric donation, relatives stipulated the skin colour of the recipient. A review by the Department of Health ruled that such practice is unacceptable and that a donated organ is given as a gift to society. The corollary of this ruling is that a just and fair system must exist to distribute this scarce resource, with broad agreement on what the boundaries of acceptability are. This may include positive discrimination in favour of certain ethnic groups who may otherwise find it difficult to obtain a kidney because of poor matches. It is anticipated that the Human Tissue Act 2004 will allow paired donation, provided there is a satisfactory report from an HTA-trained independent assessor.
Other initiatives Organ trade: in Europe, patients wait an average of 6 years before receiving a kidney. Whilst waiting, patients cannot lead a life as active as they would like. This has led to patients being able to buy kidneys from foreign donors. Unsurprisingly, the trade in organs is growing, with many countries declaring the practice to be illegal and unethical. The recently enacted Human Tissue Act in Scotland states that a person commits an offence if he or she gives or receives a reward for the supply of, or an offer to supply, any part of a human body for transplantation. Inevitably, the buyers come from rich countries, while monetary remuneration is the main aim of many donors living in impoverished countries. These donors are willing to sell an organ they believe they can live without. However, there is evidence that once the kidney is taken from the donor, the problems that originally prompted them to donate are not resolved. There are also health consequences for the donor. From a religious viewpoint, the legitimacy of a medical intervention has to be the promotion of the human as a whole, in harmony with the unique dignity possessed by every human by virtue of his or her humanity. Pope John Paul II, in an address to the 18th International Congress of the Transplantation Society, 29th August 2000, stated: ‘any procedure which tends to commercialize human organs or to consider them as items of exchange or trade must be considered morally unacceptable, because to use the body as an object is to violate the dignity of the human person.’ Within Protestantism, the body, as a gift of God, is the property of no one and therefore exchange can take the form only of a gift. Within the Greek Orthodox Church, the donation of organs by donors whose brain is diagnosed to have died, and the informed conscious consent of a healthy person to donate his or her organs to another person, are considered acts of altruism and love, and are in keeping with the teaching and thinking of that Church.
Domino transplants occur when organs become available from a recipient during a transplant procedure (e.g. a healthy heart during a heart-lung transplant). This form of transplantation currently requires approval by the Unrelated Live Transplant Regulatory Authority (ULTRA), which was set up under the Human Organ Transplants Act 1989 to approve all transplant operations involving a living donor who is not a close blood relative of the recipient. This Act will be replaced by the Human Tissue Act, and ULTRA will then cease to exist. The Human Tissue Act is likely to permit domino transplants. Altruistic donation occurs when a healthy person wishes to donate a kidney or lobe of liver or lung to a patient whom they do not know. While this may be hard to comprehend, people do extraordinary things to help others. There have been recent cases of altruistic donation in the USA. The main question surrounding this is whether society should limit a person’s choice if it may lead to his or her harm. It is essential to confirm that the donor fully understands the risks involved. Other sources of organs Other suggested sources of donors include anencephalous patients, elective ventilation of patients in deep irreversible coma, and executed prisoners. Although anencephalic infants have been proposed as a source of organs, this would require a special category of death since by definition they have a functioning brainstem. However,
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Cadaveric Signing an organ donor card implies a willingness to be a donor. However, in the past, relatives could veto that request. Under the new legislation, the carrying of a donor card or registering on the NHS Organ Donor Register (currently 21% of the population, have registered) will be given authorisation and regarded as an advance directive so that the wishes of the deceased will be fulfilled wherever possible. In addition, relatives will be regarded as those who had been closest to the potential donor, and thus will be most likely to have known his or her views. In many central and eastern European countries, donation is based on presumed consent or an ‘opting out’ system (i.e. if a person does not register an objection to being a donor during their life then consent is presumed). However, this can be interpreted as coercive because silence is regarded as an agreement to do something. Furthermore, for many people, presumed consent does not represent a valid form of consent. Therefore, in the UK the new legislation still supports an ‘opt in’ system.
Counter-arguments suggest that more-developed countries are behaving in a paternalistic manner towards poorer, less-developed countries. Many of these arguments are contrary to the principle of autonomy, where individuals could rightly argue that they should decide what to do with their bodies and whether to accept any attendant risks. With respect to the organ trade, the financial pressures to sell may not be appreciated in more affluent countries. In some countries without a cadaveric transplant programme it may be the only source of organs. Ultimately, the main reason for arguing against organ trafficking is that both donor and recipient are exploited. A form of regulation to remove this exploitation would make the process much safer, and ethical and legal arguments against the organ trade would become much weaker and possibly be unsustainable. Indeed, the boundary between the sale of organs and rewarding donation through compensatory mechanisms is not very distinct. Even more controversially, it could be argued that paired exchange, as previously discussed, is a form of organ trade because the kidney is not offered unless one given in return.
Non-heart-beating organ donation As mentioned, there is limited time in which to obtain consent and harvest organs, and this limitation carries the risk of misunderstandings. Once a decision has been made to withdraw or withhold treatment, the suitability of the patient for non-heart-beating donation should be discussed with the transplant coordinator before approaching the patient’s family. This avoids the situation of establishing the family’s agreement only to find that the patient is unsuitable. Similarly, it may be necessary to discuss this with the coroner or procurator fiscal first. The possibility of non-heart-beating organ donation should be discussed with the family only after they have understood and accepted the futility of further intervention and also that treatment will be withheld or withdrawn, leading to the death of the patient. The priority is to expedite organ removal before deterioration. However, previously, relatives had to be present at death or before death to enable consent. If they were not present, it was unclear whether surgeons could preserve these organs without such consent, and thus some families have expressed concern that the opportunity to donate was lost. From April 2006, the Human Tissue Act 2004 will provide transplant surgeons with the legal authority to keep the organs of dead patients artificially alive without consent, thereby giving them time to obtain permission from relatives not present at the time of death. This will be done by administering cooling and preservative solutions into the dead patient.
Compensation: in the USA, in an effort to increase organ donation, a number of incentives have been proposed, including medals of honor for bereaved families, reimbursement of funeral expenses, and donor insurance in case of morbidity or mortality. There have also been proposals for regulated reward systems to benefit organs and increase organ quality. However, this undermines the principle, highlighted above, that people should not sell parts of their body, and promotes organs as products for sale. New legislation: newly enacted legislation in the UK should address shortcomings arising from previous legislation, such as the Human Tissue Act 1961 and the Human Organ Transplants Act 1989, which governed organ donation and transplantation. In particular, previous legislation covered both transplantation and hospital post-mortem examinations, which merely confused the public. Thus, these Acts have been replaced by separate legislation governing, firstly, organ and tissue donation and, secondly, retention of organs and tissue at post-mortem examination. Paradoxically, the 1989 Act excluded spouses from donating except with permission from ULTRA. Previous legislation also failed to acknowledge the reality of many contemporary relationships, which may not involve marriage or couples of the same sex. Furthermore, the use of the term ‘spouse’ was held to be both dated and restrictive, and the legislation seemed to treat the views of the surviving spouse and the most distant relative equally. The role of the ‘person lawfully in possession of the body’ was also unclear. By far the biggest problem in practice was that the decision whether or not to proceed with organ retrieval rested with the relatives. The wishes of the deceased, whether expressed by carrying a donor card or by having their name on the NHS Organ Donor Register, could be vetoed by relatives.
Live donation The issue of consent is also very important when live donation is being considered. The donor’s decision needs to be fully altruistic. It is essential that family pressure to donate or emotional blackmail is detected during the preoperative assessment process. This can be difficult to detect, but, if found, the problem then is what to do about it. Frequently, a clinical incompatibility excuse is given. However, care needs to be taken so that the donation option can still be used later. Although some would argue that this approach involves an element of dishonesty, it maintains donor autonomy and family relationships, and prevents recipient alienation.
Consent Issues surrounding consent and autonomy are central to many of the ethical discussions relating to organ donation. Public faith in the organ donor system was marred by the scandal of baby organ retention without consent. Patient autonomy lies at the very heart of modern medicine, and the integrity of the human is held to be paramount in western society.
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a distinction between the body and the patient. However, a family regards their relative’s body as having value and this must be respected. Diagnosing brainstem death provides an important demarcation between therapeutic medical care for the patient and the involvement of the transplant team. It must be stressed that the establishment and acceptance of brainstem death criteria were separate and unrelated to the introduction of transplantation techniques, although they were closely related in time. Some cultures do not accept brainstem death criteria, mainly because certain beliefs about death make it difficult to equate brainstem death with actual death. Furthermore, the number of heart-beating donors is declining. This is because fewer young people are dying as a result of an accident or cerebrovascular event, whilst there have been improvements in the diagnosis and management of severe brain injuries, leading to fewer patients fulfilling brainstem death criteria. Thus, other means of obtaining organs suitable for transplantation need to be considered.
Transplantation: ethical and legal considerations Nick Pace
The first successful human kidney transplant took place in 1954, thereby establishing one of the great medical innovations and advancements of modern time. However, new ethical dilemmas were introduced into medicine at the same time. As transplantation becomes more complex, these ethical dilemmas are becoming more acute, especially as the techniques are now well established. Indeed, it would be impossible to fully discuss these dilemmas in the limited space available here. This article highlights some recent developments and should be read in conjunction with Anaesthesia and Intensive Care Medicine 4:5:162. A successful transplant leads to an improved duration and quality of life for the recipient, and in many cases it can be life saving. Furthermore, outcomes continue to improve, and currently approximately 90% of recipients are alive and well 1 year after transplant. However, the scarcity of suitable organs means that not all those requiring an organ can receive one. Because demand far exceeds supply, an ever-widening gap is created. Most of the ethical concerns relate to this discrepancy, with the shortage of donor organs being the biggest problem facing transplant programmes. Furthermore, the success of long-term replacement therapy has created growing waiting lists for renal transplantation. Unfortunately, such an option is not available to patients needing heart, lung or liver transplants, and in these cases an urgent or sometimes emergency operation is required. There were 6545 patients on the waiting list for an organ transplant on 1st January 2006. Recent data suggest that more than 400 of these patients will die each year before an organ becomes available. In the past 9 months, 1717 patients received an organ, while 592 donated (www.uktransplant.org.uk).
Non-heart-beating organ donors Before the establishment of brainstem death criteria, organs were obtained from cadavers whose heart had stopped; so called nonheart-beating organ donation. The fundamental problem with this was poor organ function due to warm ischaemia damage. However, recent advances in organ protection, immunosuppression and surgical techniques have led to renewed interest in obtaining organs from such donors. Indeed, the 1-year and 5-year kidney transplant results are similar whether the kidney was obtained from a brainstem dead cadaver or a non-heart-beating organ donor. Thus, the latter can no longer be dismissed on the grounds of organ viability, and there are suggestions that increased use (currently these donors contribute only 3% of transplanted organs) could increase organ availability by up to 20%, thereby making a major contribution to waiting list reduction. However, more successful outcomes will ensue only if strategies can be devised to keep warm ischaemia times as short as possible. In all cases, declaration of death occurs after the cessation of circulation and respiratory function. In 1995 the Maastricht classification identified four categories of potential donors (Figure 1). A fifth category has recently been suggested to identify a more specific group: unexpected cardiac arrest in a patient in ICU. Categories 1, 2, 4 and 5 have been described as ‘uncontrolled’ donation. All preparations for retrieval have to take place from the time of death and be completed before the maximum recommended warm ischaemia time of 45 minutes has been reached. These preparations include addressing issues of consent, counselling relatives, preparation of the donor (tissue typing, viral status), mobilizing a surgical team, and finally cold perfusion of the organs. The anaesthetist on the arrest team in the ward, on stand-by in the accident and emergency department or, more significantly, at an unexpected arrest in an ICU patient could be involved in the declaration of death and notification of the transplant team. Category 3 is a controlled donation. Category 4 can also occasionally be considered a controlled donation, depending how far along the process has progressed when the patient arrests. These patients are generally more stable, their condition is deemed to be futile, and a decision to not introduce care or to withdraw care has been made. Asystole and cardiac arrest are thus predicted and expected. The preparations mentioned above can be made before death occurs and organ retrieval can be scheduled. This makes it easier
Organ supply Cadaveric Currently, in the UK, most organs are supplied from cadaveric donors in whom brainstem death has been confirmed and, therefore, whose hearts are still beating. The maintenance of ventilation and circulatory support allows time for discussions with relatives, potential donor screening, and a more controlled approach to organ retrieval, with short warm ischaemia times. How we should care for the body after death is fundamental to discussions regarding organ supply. Some would argue that there is
Nick Pace is Consultant Anaesthetist at the Western Infirmary, Glasgow. He trained in Glasgow, Cardiff, Riyadh and Dallas. His main interests are anaesthesia for renal and endocrine diseases, transplantation and trauma. He has masters and doctorate degrees in medical law and ethics.
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contentious issue and reflects the author’s personal belief. Recent legal advice may support this view; however, it is contrary to that of the Intensive Care Society, which rightly takes a conservative approach. All would agree that it would certainly be inappropriate to use such drugs if they could potentially accelerate the patient’s death (e.g. significant risk of catastrophic haemorrhage if heparin were given). The use of these drugs should be explained to the relatives when consent is being obtained (an issue that will be discussed later). Third, the use of aorto-femoral cannulation can be problematic. Perfusion with cold preservative can be used to maintain organ viability, buying time to allow a more relaxed surgical retrieval. This can be very useful in uncontrolled donation, but with controlled donation there could be problems with obtaining consent. Fourth, and probably most importantly, there are difficulties with the confirmation and certification of death. The traditional loose definitions and timings of cardiac death are challenged by non-heartbeating donation. For example, what is the legal definition of death? Cardiorespiratory cessation and brain death are not identical. Some protocols are vague with regard to how death is determined and at which point organ preservation and retrieval can be undertaken. In practice, the patient is deemed to be dead if they are not hypothermic and are irreversibly unresponsive, apnoeic and asystolic. However, the moment of arrest is not irreversible and there is no consensus on how much time must pass after cardiac arrest before death becomes irreversible. Although without resuscitation apnoea and asystole are taken to be irreversible after 2 minutes, permanent loss of brain function may take a lot longer. Since there is no method to determine when loss of brain function is irreversible, it seems appropriate to wait for a period of time that would put this beyond doubt. However, dfferent groups use different times and this would have to be discussed and agreed at local level. Most groups agree that confirmation and certification of death should be undertaken a minimum of 5 minutes after cardiorespiratory arrest. Early discussions with local authorities that deal with and investigate deaths, such as coroners, procurators fiscal and the police, are essential before the introduction of any protocol.
Categories of non-heart-beating donors Category 1 Dead on arrival at hospital: patients who suffer an out-of-hospital arrest and arrive in hospital with an accurate documentation of the time of death and pre-hospital resuscitation Category 2 Unsuccessful resuscitation: patients who arrest in hospital and have an accurately documented failed resuscitation attempt Category 3 Awaiting cardiac arrest: patients who present to the accident and emergency department with a non-survivable injury, or those in a general or neurosurgical ICU whose death is inevitable. They do not fulfil brainstem death criteria and therefore cannot become a heart-beating donor Category 4 Cardiac arrest in a heart-beating donor: patients whose death has been confirmed by brainstem testing but arrest before organ retrieval can take place 1
to minimize warm ischaemia times, and consequently the organs procured should be of a higher quality and carry a better prognosis after transplantation than organs from uncontrolled donation. The implementation of non-heart-beating organ donation would involve changes to the existing transplant framework. Controlled donation offers the best opportunity to introduce this type of donation successfully, and ICUs would be the focus for identifying potential donors. An accident and emergency programme is more difficult to introduce, especially with respect to proper resourcing, such as surgical availability. In all cases, there are several ethical and legal concerns that need further examination. Recently, the Intensive Care Society has issued guidance on the optimum management of non-heart-beating organ donation in adult critical care units. First, the decision regarding the futility of further treatment needs to be made in accordance with current guidelines, such as those produced by the British Medical Association or the General Medical Council, and deemed to be in the patient’s best interests. The timing of the whole process may be influenced by the need to ensure optimum organ viability, and thus there may be a conflict between trying to reduce warm ischaemia times and good medical care. Doctors continue to have a duty of care to the potential donor until the moment of death. To avoid any conflict of interest, the initial decision to withdraw care or to stop resuscitation in the accident and emergency department should be made on the basis of a multidisciplinary discussion, precede and be clearly separate from consideration of donation, and not involve any of the transplant team. Second, once the decision is taken to withhold or withdraw treatment, the escalation of current treatment in order to improve organ viability would be inappropriate. However, the administration of steroids, antibiotics and heparin may be used to minimize organ deterioration after death and can be justified because it may help fulfil the patient’s wish to donate organs. Please note that this is a very
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Live donation This type of donation is becoming an increasingly popular source of organs in the UK. In parts of the world that do not accept brainstem death criteria, live donation may be the only source of organs. Living donation of kidney, liver lobe or lung lobe has increased as waiting lists increase and cadaveric organs become increasingly scarce. In the UK the proportion of kidney transplants involving live donors is now approaching 25%. The benefits to the recipient are clear. They include a reduced waiting time, a scheduled procedure, which may even be undertaken pre-dialysis, a reduced cold ischaemia time and long graft survival. However, the benefits to the donor are not so clear and may be purely psychological. How does the ethical principle of ‘firstly do no harm’ sit with live donation? It is not clear whether this is an absolute position. The risks of morbidity and mortality to the donor depend on the organ or lobe donated, and thus an appropriate risk–benefit assessment needs to be undertaken. Globally, adult-toadult transplantation of the right liver lobe has a donor mortality of about 1%, while kidney donation has a mortality of 0.03%. Surprisingly, the Council of Europe has stated that organ removal from living donors must remain the exception because of the possible risks to the donor. Thus, such removal may be carried out only when there is no suitable organ available from a dead donor and 186
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there is no other alternative therapeutic method of similar effectiveness. Clearly, this position is not sustainable and indeed many EU countries, including the UK, are aiming to increase the proportion of live organ donation. However, it may be ethically appropriate to refuse an offer of an organ if the risk to the donor is too great. At the same time it is essential that other ethical principles, namely autonomy and beneficence, are considered. Indeed, the most serious concern lies with the possibility of improper pressure being applied to a donor; a point that will be returned to later when discussing consent. Other issues that arise when discussing live donation include paired exchange, domino transplants and altruistic donation.
this category could logically be extended to other patients, such as those in a persistent vegetative state, which society would find unacceptable. Elective ventilation was proposed a number of years ago. This entailed the transfer of patients in a deep irreversible coma to ICU so that they could be intubated and ventilated as soon as they suffered a respiratory arrest. Support could be continued until the patient became brainstem dead and donation would proceed in the same manner as a cadaveric donation. However, many believed that it was wrong to prolong life and alter the mode of dying for the benefit of others and the practice was deemed illegal and abandoned. Executed prisoners have been used as a source of organs in some countries for many years. Arguments abound both for and against such a practice, and depend on what ethical principle is given most importance. Although condemned by many, others argue that, given the possible benefits, not to use such organs would be immoral. Xenotransplantation is the transplantation between different species, and offers the prospect of an unlimited supply of organs. Not surprisingly, animal rights issues abound in discussions about the legitimacy of such a practice. However, although immunological problems continue to be problematic, the greatest barrier to further consideration remains the risk of trans-species infection. There would, however, be huge benefits in overcoming the shortage of organs, with ancillary benefits regarding work, premature death and cost of treatment.
Paired exchange involves a donor and recipient pair donating to, and receiving from, another donor/recipient pair to overcome ABO blood group incompatibility or histo-incompatibility. Studies in the USA and Holland have shown that this could be a very effective practice for difficult-to-match patients. However, this practice is currently not allowed in the UK because it is a form of directed conditional donation (i.e. agreement to donate is made on the basis of who will receive the donated organ). In a recent UK case involving cadaveric donation, relatives stipulated the skin colour of the recipient. A review by the Department of Health ruled that such practice is unacceptable and that a donated organ is given as a gift to society. The corollary of this ruling is that a just and fair system must exist to distribute this scarce resource, with broad agreement on what the boundaries of acceptability are. This may include positive discrimination in favour of certain ethnic groups who may otherwise find it difficult to obtain a kidney because of poor matches. It is anticipated that the Human Tissue Act 2004 will allow paired donation, provided there is a satisfactory report from an HTA-trained independent assessor.
Other initiatives Organ trade: in Europe, patients wait an average of 6 years before receiving a kidney. Whilst waiting, patients cannot lead a life as active as they would like. This has led to patients being able to buy kidneys from foreign donors. Unsurprisingly, the trade in organs is growing, with many countries declaring the practice to be illegal and unethical. The recently enacted Human Tissue Act in Scotland states that a person commits an offence if he or she gives or receives a reward for the supply of, or an offer to supply, any part of a human body for transplantation. Inevitably, the buyers come from rich countries, while monetary remuneration is the main aim of many donors living in impoverished countries. These donors are willing to sell an organ they believe they can live without. However, there is evidence that once the kidney is taken from the donor, the problems that originally prompted them to donate are not resolved. There are also health consequences for the donor. From a religious viewpoint, the legitimacy of a medical intervention has to be the promotion of the human as a whole, in harmony with the unique dignity possessed by every human by virtue of his or her humanity. Pope John Paul II, in an address to the 18th International Congress of the Transplantation Society, 29th August 2000, stated: ‘any procedure which tends to commercialize human organs or to consider them as items of exchange or trade must be considered morally unacceptable, because to use the body as an object is to violate the dignity of the human person.’ Within Protestantism, the body, as a gift of God, is the property of no one and therefore exchange can take the form only of a gift. Within the Greek Orthodox Church, the donation of organs by donors whose brain is diagnosed to have died, and the informed conscious consent of a healthy person to donate his or her organs to another person, are considered acts of altruism and love, and are in keeping with the teaching and thinking of that Church.
Domino transplants occur when organs become available from a recipient during a transplant procedure (e.g. a healthy heart during a heart-lung transplant). This form of transplantation currently requires approval by the Unrelated Live Transplant Regulatory Authority (ULTRA), which was set up under the Human Organ Transplants Act 1989 to approve all transplant operations involving a living donor who is not a close blood relative of the recipient. This Act will be replaced by the Human Tissue Act, and ULTRA will then cease to exist. The Human Tissue Act is likely to permit domino transplants. Altruistic donation occurs when a healthy person wishes to donate a kidney or lobe of liver or lung to a patient whom they do not know. While this may be hard to comprehend, people do extraordinary things to help others. There have been recent cases of altruistic donation in the USA. The main question surrounding this is whether society should limit a person’s choice if it may lead to his or her harm. It is essential to confirm that the donor fully understands the risks involved. Other sources of organs Other suggested sources of donors include anencephalous patients, elective ventilation of patients in deep irreversible coma, and executed prisoners. Although anencephalic infants have been proposed as a source of organs, this would require a special category of death since by definition they have a functioning brainstem. However,
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Cadaveric Signing an organ donor card implies a willingness to be a donor. However, in the past, relatives could veto that request. Under the new legislation, the carrying of a donor card or registering on the NHS Organ Donor Register (currently 21% of the population, have registered) will be given authorisation and regarded as an advance directive so that the wishes of the deceased will be fulfilled wherever possible. In addition, relatives will be regarded as those who had been closest to the potential donor, and thus will be most likely to have known his or her views. In many central and eastern European countries, donation is based on presumed consent or an ‘opting out’ system (i.e. if a person does not register an objection to being a donor during their life then consent is presumed). However, this can be interpreted as coercive because silence is regarded as an agreement to do something. Furthermore, for many people, presumed consent does not represent a valid form of consent. Therefore, in the UK the new legislation still supports an ‘opt in’ system.
Counter-arguments suggest that more-developed countries are behaving in a paternalistic manner towards poorer, less-developed countries. Many of these arguments are contrary to the principle of autonomy, where individuals could rightly argue that they should decide what to do with their bodies and whether to accept any attendant risks. With respect to the organ trade, the financial pressures to sell may not be appreciated in more affluent countries. In some countries without a cadaveric transplant programme it may be the only source of organs. Ultimately, the main reason for arguing against organ trafficking is that both donor and recipient are exploited. A form of regulation to remove this exploitation would make the process much safer, and ethical and legal arguments against the organ trade would become much weaker and possibly be unsustainable. Indeed, the boundary between the sale of organs and rewarding donation through compensatory mechanisms is not very distinct. Even more controversially, it could be argued that paired exchange, as previously discussed, is a form of organ trade because the kidney is not offered unless one given in return.
Non-heart-beating organ donation As mentioned, there is limited time in which to obtain consent and harvest organs, and this limitation carries the risk of misunderstandings. Once a decision has been made to withdraw or withhold treatment, the suitability of the patient for non-heart-beating donation should be discussed with the transplant coordinator before approaching the patient’s family. This avoids the situation of establishing the family’s agreement only to find that the patient is unsuitable. Similarly, it may be necessary to discuss this with the coroner or procurator fiscal first. The possibility of non-heart-beating organ donation should be discussed with the family only after they have understood and accepted the futility of further intervention and also that treatment will be withheld or withdrawn, leading to the death of the patient. The priority is to expedite organ removal before deterioration. However, previously, relatives had to be present at death or before death to enable consent. If they were not present, it was unclear whether surgeons could preserve these organs without such consent, and thus some families have expressed concern that the opportunity to donate was lost. From April 2006, the Human Tissue Act 2004 will provide transplant surgeons with the legal authority to keep the organs of dead patients artificially alive without consent, thereby giving them time to obtain permission from relatives not present at the time of death. This will be done by administering cooling and preservative solutions into the dead patient.
Compensation: in the USA, in an effort to increase organ donation, a number of incentives have been proposed, including medals of honor for bereaved families, reimbursement of funeral expenses, and donor insurance in case of morbidity or mortality. There have also been proposals for regulated reward systems to benefit organs and increase organ quality. However, this undermines the principle, highlighted above, that people should not sell parts of their body, and promotes organs as products for sale. New legislation: newly enacted legislation in the UK should address shortcomings arising from previous legislation, such as the Human Tissue Act 1961 and the Human Organ Transplants Act 1989, which governed organ donation and transplantation. In particular, previous legislation covered both transplantation and hospital post-mortem examinations, which merely confused the public. Thus, these Acts have been replaced by separate legislation governing, firstly, organ and tissue donation and, secondly, retention of organs and tissue at post-mortem examination. Paradoxically, the 1989 Act excluded spouses from donating except with permission from ULTRA. Previous legislation also failed to acknowledge the reality of many contemporary relationships, which may not involve marriage or couples of the same sex. Furthermore, the use of the term ‘spouse’ was held to be both dated and restrictive, and the legislation seemed to treat the views of the surviving spouse and the most distant relative equally. The role of the ‘person lawfully in possession of the body’ was also unclear. By far the biggest problem in practice was that the decision whether or not to proceed with organ retrieval rested with the relatives. The wishes of the deceased, whether expressed by carrying a donor card or by having their name on the NHS Organ Donor Register, could be vetoed by relatives.
Live donation The issue of consent is also very important when live donation is being considered. The donor’s decision needs to be fully altruistic. It is essential that family pressure to donate or emotional blackmail is detected during the preoperative assessment process. This can be difficult to detect, but, if found, the problem then is what to do about it. Frequently, a clinical incompatibility excuse is given. However, care needs to be taken so that the donation option can still be used later. Although some would argue that this approach involves an element of dishonesty, it maintains donor autonomy and family relationships, and prevents recipient alienation.
Consent Issues surrounding consent and autonomy are central to many of the ethical discussions relating to organ donation. Public faith in the organ donor system was marred by the scandal of baby organ retention without consent. Patient autonomy lies at the very heart of modern medicine, and the integrity of the human is held to be paramount in western society.
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