ARGUMENTS AGAINST PROMOTING ORGAN TRANSPLANTS FROM BRAIN‐DEAD DONORS,AND VIEWS OF CONTEMPORARY JAPANESE ON LIFE AND DEATH

As of 2009, the number of donors in Japan is the lowest among developed countries. On July 13, 2009, Japan's Organ Transplant Law was revised for the first time in 12 years. The revised and old laws differ greatly on four primary points: the definition of death, age requirements for donors, requirements for brain‐death determination and organ extraction, and the appropriateness of priority transplants for relatives. In the four months of deliberations in the National Diet before the new law was established, various arguments regarding brain death and organ transplantation were offered. An amazing variety of opinions continue to be offered, even after more than 40 years have elapsed since the first heart organ transplant in Japan. Some are of the opinion that with the passage of the revised law, Japan will finally become capable of performing transplants according to global standards. Contrarily, there are assertions that organ transplants from brain‐dead donors are unacceptable because they result in organs being taken from living human beings. Considering the current conditions, we will organize and introduce the arguments for and against organ transplants from brain‐dead donors in contemporary Japan. Subsequently, we will discuss the primary arguments against organ transplants from brain‐dead donors from the perspective of contemporary Japanese views on life and death. After introducing the recent view that brain death should not be regarded as equivalent to the death of a human being, we would like to probe the deeply‐rooted views on life and death upon which it is based.     

Brain death and the anencephalic newborn

We will set the stage for our analysis by reviewing selected medical aspects of anencephaly, outlining the history of the use of anencephalics as organ sources, and summarising the results of an important study recently completed at Loma Linda University. We will then employ some of the arguments and justifications underlying the Uniform Determination of Death Act (UDDA) to claim that anencephaly is morally equivalent to brain death, i.e., the reasons for considering brain-dead patients to be dead also apply to anencephalics. Finally, we will critique our proposal and discuss its implications.     

Moral sensibilities and moral standing: Caplan on xenograft "donors"

[I]nterest in animals as a source of organs and tissues for human beings remains strong. New developments in immunosuppression technology promise to lower the technical barriers to a routine use of nonhumans as organ donors, and the image of colonies of animals kept at the ready for supplying the growing human need for new organs seems a much more plausible scenario now than it did when broached by transplantation specialists in the Sixties. As Arthur Caplan has powerfully argued, the prospects that other sources of organs may resolve the supply problem are grim.... In the face of these "pro-xenograft" pressures, it becomes all the more signficant to assess arguments against the practice that rest on considerations of the moral status of the nonhumans from whom the organs are taken. To be sure, xenograft faces other moral difficulties -- for example, concerns about the quality of informed consent obtained for recipients, worries about the possibility that xenografting will serve as a vector by which new and possibly virulent viruses become established in humans, and problems about whether such spending is equitable in the light of other unresolved human needs. Yet whether we morally wrong animals in taking their organs and their lives remains a decidedly central issue here, one that cannot be finessed away by developing better informed consent procedures, better anti-viral strategies, or by situating transplantation medicine in a just health care system.     

Against the family veto in organ procurement: Why the wishes of the dead should prevail when the living and the deceased disagree on organ donation

The wishes of registered organ donors are regularly set aside when family members object to donation. This genuine overruling of the wishes of the deceased raises difficult ethical questions. A successful argument for providing the family with a veto must (a) provide reason to disregard the wishes of the dead, and (b) establish why the family should be allowed to decide. One branch of justification seeks to reconcile the family veto with important ideas about respecting property rights, preserving autonomy, and preventing harm. These arguments are ultimately unsuccessful. Another branch of arguments is consequentialist, pointing out the negative consequences of removing the veto. Whether construed as concerning family distress or as a potential drop in the organs available, these arguments are unsuccessful; the first fails to recognize the tremendous distress associated with waiting for an organ, while the second has little supporting evidence. A final section considers and rejects whether combining some of the arguments just examined could justify the family veto. We should thus remove the family veto in organ donation.     

Brain stem death and organ donation.

Organs for donation are in short supply in the United Kingdom, resulting in allegations that relatives of potential donors are not being asked for consent. Legislation on "required request" has been proposed to overcome this. The incidence, causes, complications, and patterns of organ donation in brain stem dead patients in one referral centre were studied over 12 months. Data were collected on all patients fulfilling criteria for brain stem death or considered suitable for donating organs after circulatory arrest. Forty two patients fulfilled the criteria for brain stem death, and in 10 further patients circulatory arrest occurred before formal testing was finished. The major causes of brain stem death were head injury (28) and intracranial haemorrhage (17). Consent to organ donation was obtained for 24 potential donors, and organs were donated by 23 of them. Twenty nine patients did not donate organs. The commonest reasons for failure to donate were medical unsuitability (13) and the coroner not releasing the body (eight). Consent was not sought in three cases, and the relatives refused consent in the remaining five. This study suggests that required request will not considerably increase the supply of donor organs.     

Fetal Tissue Banking for Transplantation: Characteristics of the Donor Population and Considerations for Donor and Tissue Screening

We initiated this study to evaluate the suitability for therapeutic use in transplantation of tissues obtained from human abortuses. We have developed protocols for the collection, handling and preservation of hepatic stem cells from electively aborted embryos and have developed methods for assessment of the cells so derived and processed. In this paper we present our findings regarding screening of potential donors, acquisition of fetal tissues, and assessment of the tissues for potentially infectious contaminants. We assess the suitability of the tissue donors according to current standards used for donors of commonly transplanted tissues (e.g., bone grafts, skin grafts and heart valves) and present data regarding the real availability of tissues from elective abortion procedures that would meet those standard tissue banking criteria.We specifically evaluated the donor's willingness to provide a blood sample for testing, conducted a detailed interview similar to those used for typical organ and tissue donors, and assessed the type and incidence of contamination in collected tissues. We find that although many women are willing to consent to use of the tissues for transplantation, attrition from the study for various reasons results in few fetal organs ultimately realistically available for transplantation. Typical reasons for attrition include: unwillingness to have a blood sample drawn or tested, positive serology results, social/medical high risk factors for acquisition of transmissible disease, no identifiable organs available, and unacceptable microbial contamination. Thus, although it might seem that due to the numbers of abortions performed annually, that there would be substantial numbers of suitable tissues available, only a small proportion are truly suitable for transplantation.     

Brain death and organ donation in a neurosurgical unit: audit of recent practice.

OBJECTIVE--To assess the potential for increasing the yield of donors by comparing the current pattern of brain death and organ donation in a neurosurgical unit with that reported in 1981 and with a recent national audit. DESIGN--Retrospective review of all deaths for 1986, 1987, and 1988 and prospective data for 1989. SETTING--A regional neurosurgical unit serving 2.7 million population. RESULTS--Of 553 deaths, 35% (191) patients died while on a ventilator and 17% (92) after discontinuation of ventilation. Medical contraindications to donation were found in 23% (32) of 141 patients tested for brain death, in 38% (19) of 50 patients who died while being ventilated who were not tested, and in 12% (11) of 92 patients no longer being ventilated. Consent for donation was sought in 88% (96) of 109 medically suitable brain dead patients and granted in 70% (67) of these. Half those with permission for multiorgan donation had only the kidneys removed. CONCLUSIONS--More organs may be lost owing to transplant team logistics than by failure to seek consent from relatives of brain dead patients. The estimated size of the pool of potential donors depends on what types of patients might be considered. Ensuring that all who die while being ventilated are tested for brain death and considering the potential for donation before withdrawing ventilation could yield more donors. Ventilating more patients who are hopelessly brain damaged to secure more donors raises ethical and economic issues.     

THE DEAD DONOR RULE,VOLUNTARY ACTIVE EUTHANASIA,AND CAPITAL PUNISHMENT

We argue that the dead donor rule, which states that multiple vital organs should only be taken from dead patients, is justified neither in principle nor in practice. We use a thought experiment and a guiding assumption in the literature about the justification of moral principles to undermine the theoretical justification for the rule. We then offer two real world analogues to this thought experiment, voluntary active euthanasia and capital punishment, and argue that the moral permissibility of terminating any patient through the removal of vital organs cannot turn on whether or not the practice violates the dead donor rule. Next, we consider practical justifications for the dead donor rule. Specifically, we consider whether there are compelling reasons to promulgate the rule even though its corresponding moral principle is not theoretically justified. We argue that there are no such reasons. In fact, we argue that promulgating the rule may actually decrease public trust in organ procurement procedures and medical institutions generally – even in states that do not permit capital punishment or voluntary active euthanasia. Finally, we examine our case against the dead donor rule in the light of common arguments for it. We find that these arguments are often misplaced – they do not support the dead donor rule. Instead, they support the quite different rule that patients should not be killed for their vital organs.     

Organ Donation: Who Should Decide?—A Canadian Perspective

This paper examines an under-explored issue in organ donation: whose decision making authority should be privileged posthumously in the context of known, explicit consent for donation? Current practices in Canada support the family as the ultimate decision maker, despite the existence of legislative support in many Canadian provinces for the potential donor as legitimate decision maker. Arguments for and against privileging the family and the potential donor are identified. Informing the question of “who should decide” are considerations of individual and relational autonomy, distributive and social justice, personhood, and arguments “from distress”. Tensions and competing obligations emerge from an exploration of these considerations that call for further, inclusive dialogue and deliberation on this important organ donation issue.     

Non-heart-beating organ donors as a source of kidneys for transplantation: a chart review

BACKGROUND: Organ transplantation is the treatment of choice for patients with end-stage organ failure, but the supply of organs has not increased to meet demand. This study was undertaken to determine the potential for kidney donation from patients with irremediable brain injuries who do not meet the criteria for brain death and who experience cardiopulmonary arrest after withdrawal of ventilatory support (controlled non-heart-beating organ donors). METHODS: The charts of 209 patients who died during 1995 in the Emergency Department and the intensive care unit at the Foothills Hospital in Calgary were reviewed. The records of patients who met the criteria for controlled non-heart-beating organ donation were studied in detail. The main outcome measure was the time from discontinuation of ventilation until cardiopulmonary arrest. RESULTS: Seventeen potential controlled non-heart-beating organ donors were identified. Their mean age was 62 (standard deviation 19) years. Twelve of the patients (71%) had had a cerebrovascular accident, and more than half (10 [59%]) did not meet the criteria for brain death because one or more brain stem reflexes were present. At the time of withdrawal of ventilatory support, the mean serum creatinine level was 71 (29) mumol/L, mean urine output was 214 (178) mL/h, and 9 (53%) patients were receiving inotropic agents. The mean time from withdrawal of ventilatory support to cardiac arrest was 2.3 (5.0) hours; 13 of the 17 patients died within 1 hour, and all but one died within 6 hours. For the year for which charts were reviewed, 33 potential conventional donors (people whose hearts were beating) were identified, of whom 21 (64%) became donors. On the assumption that 40% of the potential controlled non-heart-beating donors would not in fact have been donors (25% because of family refusal and 15% because of nonviability of the organs), there might have been 10 additional donors, which would have increased the supply of cadaveric kidneys for transplantation by 48%. INTERPRETATION: A significant number of viable kidneys could be retrieved and transplanted if eligibility for kidney donation was extended to include controlled non-heart-beating organ donors.     

Skin Donors Positive for HBV Core Antibodies – to Bank or Not to Bank? An Overview from a Regional Tissue Bank

A prompt transplantation of skin allografts on patients with severe, large body area burns is a preferred treatment, but depends on a suitable supply of tissue donors. Limiting factors include donors' identification, families consent, and following the standards – exclusion due to assessed transmissible diseases. To increase the current rate of skin donations to our regional skin bank, we reviewed the data of all potential organ donors, identified at Soroka University Medical Center from October 1997 to December 2000 and evaluated the causes for exclusion, especially due to HBV serological profile. 114/168 (67.9%) patients did not meet the indicated standards for organ donation, among which 20/114 patients (17.5%) positive for anti-HBc (anti-HBc⁺). 54/168 persons were declared brain dead, with consents obtained from 21 families. To discuss the intriguing approval of skin from potential donors with anti-HBc⁺ serology, the literature was reviewed, specifically – the reported outcomes of organ transplants from anti-HBc⁺ donors, updates of HBV and skin, available tests, and finally a look for a safe commendable algorithm. The results suggested that HBV might be replicating in the skin, but proven communication of HBV has not been reported following grafting skin from anti-HBc⁺ donors. Unlike other procured organs and tissues, grafted banked skin is a temporary cover, storable up to six years, under appropriate conditions. Hence, banking of skin from anti-HBc⁺ donors might be considered for future grafting of patients with identical serological profiles, presumably immune to a subsequent HBV infection, until a further re-evaluation of the standards. This procedure is anticipated to increase the potential of organ and tissue donations, specifically skin.     

Should We Reject Donated Organs on Moral Grounds or Permit Allocation Using Non‐Medical Criteria?: A Qualitative Study

Conditional and directed deceased organ donations occur when donors (or often their next of kin) attempt to influence the allocation of their donated organs. This can include asking that the organs are given to or withheld from certain types of people, or that they are given to specified individuals. Donations of these types have raised ethical concerns, and have been prohibited in many countries, including the UK. In this article we report the findings from a qualitative study involving interviews with potential donors (n = 20), potential recipients (n = 9) and transplant staff (n = 11), and use these results as a springboard for further ethical commentary. We argue that although participants favoured unconditional donation, this preference was grounded in a false distinction between ‘medical’ and ‘non‐medical’ allocation criteria. Although there are good reasons to maintain organ allocation based primarily upon the existing ‘medical’ criteria, it may be premature to reject all other potential criteria as being unacceptable. Part of participants' justification for allocating organs using ‘medical’ criteria was to make the best use of available organs and avoid wasting their potential benefit, but this can also justify accepting conditional donations in some circumstances. We draw a distinction between two types of waste – absolute and relative – and argue that accepting conditional donations may offer a balance between these forms of waste.     

Dealing Death and Retrieving Organs

It has recently been argued by Miller and Truog (2008) that, while procuring vital organs from transplant donors is typically the cause of their deaths, this violation of the requirement that donors be dead prior to the removal of their organs is not a cause for moral concern. In general terms, I endorse this heterodox conclusion, but for different and, as I think, more powerful reasons. I end by arguing that, even if it is agreed that retrieval of vital organs causes the deaths of those who provide them, that does not pose any new substantive difficulties for efforts to justify “opt-out” organ procurement systems.     

Trust and the Duty of Organ Donation

Several recent publications in biomedical ethics argue that organ donation is generally morally obligatory and failure to do so is morally indefensible. Arguments for this moral conclusion tend to be of two kinds: arguments from fairness and arguments from easy rescue. While I agree that many of us have a duty to donate, in this article I criticize these arguments for a general duty of organ donation and their application to organ procurement policy. My concern is that these arguments neglect the role that trust plays in contemporary organ transplant policies and in differential rational attitudes toward donation. Recognizing donation as an achievement of trust, and acknowledging the warrant of many people's rational distrust or withheld trust in medicine, I argue, should have significant implications for the ethics of organ procurement.     

Permanence can be Defended

In donation after the circulatory‐respiratory determination of death (DCDD), the dead donor rule requires that the donor be dead before organ procurement can proceed. Under the relevant limb of the Uniform Determination of Death Act 1981 (USA), a person is dead when the cessation of circulatory‐respiratory function is ‘irreversible’. Critics of current practice in DCDD have argued that the donor is not dead at the time organs are procured, and so the procurement of organs from these donors violates the dead donor rule. We offer a new argument here in defence of current DCDD practice, and, in particular, of the interpretation of the requirement of ‘irreversibility’ as permanence.     

Potential availability of cadaver organs for transplantation.

OBJECTIVE--To determine the potential number of cadaver kidney donors by applying defined donor criteria to people dying in hospital. DESIGN--Prospective study of all deaths occurring in 21 hospitals from 1 September 1988 to 31 August 1989. Questionnaires were administered to medical and nursing staff and families of potential donors aged 1-69. SETTING--Acute care hospitals in Gwent, South Glamorgan, Mid Glamorgan, West Glamorgan, Pembrokeshire, and East Dyfed health authorities, serving a population of 2.2 million. MAIN OUTCOME MEASURES--Cause of death, age, ventilation at time of death, diagnosis of brain death, and consideration of consent. RESULTS--Adequate data were available for 9840 of 10,095 hospital deaths (97.5% coverage). 188 patients aged 0-69 were identified as potential organ donors (widest definition), and of these 108 died without being ventilated at the time of death. Tests of brain stem death were formally completed in 57 cases, and organ donation was considered by the families of 47 of these potential donors. 26 patients became organ donors. Patients aged 50-69 with stroke were less likely to be ventilated than those aged less than or equal to 49 (21/96 v 24/34). Families of potential donors aged 20-39 were least likely to give permission. CONCLUSIONS--The supply of donor organs (specifically kidneys) could be increased by altering the management of patients aged 50-69 dying of severe cerebrovascular disease in general medical wards, in particular by increasing the proportion ventilated. The ethics of elective ventilation for the purposes of organ donation require discussion.     

Heart transplantation in the Netherlands: quo vadis?

Heart transplantation is limited by the lack of donor organs. Twenty years after the start of the Dutch transplant programmes in Rotterdam and Utrecht the situation has even worsened, despite efforts to increase the donor pool. The Dutch situation seems to be worse than in other surrounding countries, and several factors that may influence donor organ availability and organ utilisation are discussed. The indications and contraindications for heart transplantation are presented, which are rather restrictive in order to select optimal recipients for the scarce donor hearts. Detailed data on donor hearts, rejected for transplantation, are shown to give some insight into the difficult process of dealing with marginal donor organs. It is concluded that with the current low numbers of acceptable quality donor hearts, there is no lack of capacity in the two transplanting centres nor is the waiting list limiting the number of transplants. The influence of our current legal system on organ donation, which requires (prior) permission from donor and relatives, is probably limited. The most important determinants of donor organ availability are: 1. The potential donor pool, consisting of brain dead victims of (traffic) accidents and CVAs and 2. Lack of consent to a request for donation. The potential donor pool is remarkably small in the Netherlands, due to relatively low numbers of (traffic) accidents, with an almost equal number of CVA-related brain dead patients compared with neighbouring countries. Lack of consent can only be pushed back by improved public awareness of the importance of donation and improved skills of professionals in asking permission in case there is no previous consent.     

The Consequences of Vagueness in Consent to Organ Donation

In this article I argue that vagueness concerning consent to post‐mortem organ donation causes considerable harm in several ways. First, the information provided to most people registering as organ donors is very vague in terms of what is actually involved in donation. Second, the vagueness regarding consent to donation increases the distress of families of patients who are potential organ donors, both during and following the discussion about donation. Third, vagueness also increases the chances that the patient's intention to donate will not be fulfilled due to the family's distress. Fourth, the consequent reduction in the number of donated organs leads to avoidable deaths and increased suffering among potential recipients, and distresses them and their families. There are three strategies which could be used to reduce the harmful effects of this vagueness. First, recategorizing the reasons (commonly referred to as ‘overrules’ under the current system) given by families who refuse donation from registered donors would bring greater clarity to donation discussions. Second, people who wish to donate their organs should be encouraged to discuss their wishes in detail with their families, and to consider recording their wishes in other ways. Finally, the consent system for organ donation could be made more detailed, ensuring both that more information is provided to potential donors and that they have more flexibility in how their intentions are indicated; this last strategy, however, could have the disadvantage of discouraging some potential donors from registering.     

Promoting organ donation registration with the priority incentive: Israeli transplantation surgeons' and other medical practitioners' views and ethical concerns

Because the number of organs available for transplantation does not meet the needs of potential recipients, some have proposed that a potentially effective way to increase registration is to offer a self-benefit incentive that grants a 'preferred status' or some degree of prioritization to those who register as potential donors, in case they might need organs. This proposal has elicited an ethical debate on the appropriateness of such a benefit in the context of a life-saving medical procedure. In this paper we review arguments and ethical concerns raised by scholars, and studies of views of members of the public regarding the prioritization incentive system. We also report on our study of the views of those involved in organ transplant and of other medical professionals in Israel, as over half a decade ago Israel implemented a prioritization incentive system. Bioethicists propose that key stakeholders' views can provide additional arguments and perspectives on controversial issues. Proponents justify the prioritization incentive drawing mainly on arguments related to its potential effectiveness, reciprocity and fairness. Opponents point to the fact that registering is not binding and not an actual donation, and raise concerns regarding equity, autonomy and gaming the system. Ethical concerns raised by the practitioners in the study were examined in light of scholars' arguments and actual registration and donation data. Practitioners involved in transplantation raised ethical concerns corresponding to those raised by scholars as well as additional concerns. They also challenged proponents' assumptions regarding the utility of the incentive system from their own experience and argued that proponents obscure the meaning of reciprocity.