Recovery of transplantable organs after cardiac or circulatory death: Transforming the paradigm for the ethics of organ donation

Organ donation after cardiac or circulatory death (DCD) has been introduced to increase the supply of transplantable organs. In this paper, we argue that the recovery of viable organs useful for transplantation in DCD is not compatible with the dead donor rule and we explain the consequential ethical and legal ramifications. We also outline serious deficiencies in the current consent process for DCD with respect to disclosure of necessary elements for voluntary informed decision making and respect for the donor's autonomy. We compare two alternative proposals for increasing organ donation consent in society: presumed consent and mandated choice. We conclude that proceeding with the recovery of transplantable organs from decedents requires a paradigm change in the ethics of organ donation. The paradigm change to ensure the legitimacy of DCD practice must include: (1) societal agreement on abandonment of the dead donor rule, (2) legislative revisions reflecting abandonment of the dead donor rule, and (3) requirement of mandated choice to facilitate individual participation in organ donation and to ensure that decisions to participate are made in compliance with the societal values of respect for autonomy and self-determination.     

Presumed consent for organ preservation in uncontrolled donation after cardiac death in the United States: a public policy with serious consequences

Organ donation after cessation of circulation and respiration, both controlled and uncontrolled, has been proposed by the Institute of Medicine as a way to increase opportunities for organ procurement. Despite claims to the contrary, both forms of controlled and uncontrolled donation after cardiac death raise significant ethical and legal issues. Identified causes for concern include absence of agreement on criteria for the declaration of death, nonexistence of universal guidelines for duration before stopping resuscitation efforts and techniques, and assumption of presumed intent to donate for the purpose of initiating temporary organ-preservation interventions when no expressed consent to donate is present. From a legal point of view, not having scientifically valid criteria of cessation of circulation and respiration for declaring death could lead to a conclusion that organ procurement itself is the proximate cause of death. Although the revised Uniform Anatomical Gift Act of 2006 provides broad immunity to those involved in organ-procurement activities, courts have yet to provide an opinion on whether persons can be held liable for injuries arising from the determination of death itself. Preserving organs in uncontrolled donation after cardiac death requires the administration of life-support systems such as extracorporeal membrane oxygenation. These life-support systems can lead to return of signs of life that, in turn, have to be deliberately suppressed by the administration of pharmacological agents. Finally, allowing temporary organ-preservation interventions without expressed consent is inherently a violation of the principle of respect for a person's autonomy. Proponents of organ donation from uncontrolled donation after cardiac death, on the other hand, claim that these nonconsensual interventions enhance respect for autonomy by allowing people, through surrogate decision making, to execute their right to donate organs. However, the lack of transparency and the absence of protection of individual autonomy, for the sake of maximizing procurement opportunities, have placed the current organ-donation system of opting-in in great jeopardy. Equally as important, current policies enabling and enhancing organ procurement practices, pose challenges to the constitutional rights of individuals in a pluralistic society as these policies are founded on flawed medical standards for declaring death.     

Donation after circulatory death: burying the dead donor rule

Despite continuing controversies regarding the vital status of both brain-dead donors and individuals who undergo donation after circulatory death (DCD), respecting the dead donor rule (DDR) remains the standard moral framework for organ procurement. The DDR increases organ supply without jeopardizing trust in transplantation systems, reassuring society that donors will not experience harm during organ procurement. While the assumption that individuals cannot be harmed once they are dead is reasonable in the case of brain-dead protocols, we argue that the DDR is not an acceptable strategy to protect donors from harm in DCD protocols. We propose a threefold alternative to justify organ procurement practices: (1) ensuring that donors are sufficiently protected from harm; (2) ensuring that they are respected through informed consent; and (3) ensuring that society is fully informed of the inherently debatable nature of any criterion to declare death.     

Informed consent for the diagnosis of brain death: a conceptual argument

Background

This essay provides an ethical and conceptual argument for the use of informed consent prior to the diagnosis of brain death. It is meant to enable the family to make critical end-of-life decisions, particularly withdrawal of life support system and organ donation, before brain death is diagnosed, as opposed to the current practice of making such decisions after the diagnosis of death. The recent tragic case of a 13-year-old brain-dead patient in California who was maintained on a ventilator for over 2 years illustrates how such a consent would have made a crucial difference.

Methods

Conceptual, philosophical, and ethical analysis.

Results

I first consider a conceptual justification for the use of consent for certain non-beneficial and unwanted medical diagnoses. I suggest that the diagnosis of brain death falls into this category for some patients. Because the diagnostic process of brain death lacks the transparency of traditional death determination, has a unique epistemic structure and a complex risk-benefit profile which differs markedly from case to case, and presents conflicts of interest for physicians and society, I argue that pre-diagnostic counseling and informed consent should be part of the diagnostic process. This approach can be termed as “allow cardiac death”, whose parallel logic with “allow natural death” is discussed. I also discuss potential negative impacts on organ donation and health care cost from this proposal and offer possible mitigation. I show that the pre-diagnostic counseling can improve the possibility for well-thought-out decisions regarding organ donation and terminating life-support system in cases of hopeless prognosis. This approach differs conceptually from the pluralism of the definition of death, such as those in New Jersey and Japan, and it upholds the Uniform Determination of Death Act.

Conclusions

My intention is not to provide an instant panacea for the ongoing impasse of the brain death debate, but to point to a novel conceptual ground for a more pragmatic, and more patient- and family-centered approach. By enabling the family to consent to or decline the diagnostic process of brain death, but not to choose the definition of death, it upholds the current legal definition of death.

     

Disgust sensitivity and attitudes toward organ donation among African-American college students.

241 African-American college students (94 men and 147 women, mean age = 20.3 +/- 3.4 yr.) completed the 1994 Disgust Scale of Haidt, McCauley, and Rozin and a modified form of Parisi-Rizzo's 1987 Attitudes Toward Organ Donation Scale (negative subscale only) as well as a behavioral measure of intention to donate organs after death. Analyses indicated that the higher the disgust sensitivity, the more negative the attitude toward organ donation and the less likely the student was to indicate intent to donate organs. It was further shown that negative attitudes toward organ donation mediated the relationship between disgust sensitivity and the behavioral intention measure. Results highlight the complexity of the issues surrounding organ donation within an African-American population and provide additional empirical evidence for the development of a theoretical model to explain the organ donation phenomenon.     

Defining the vital condition for organ donation

The issue of organ donation and of how the donor pool can or should be increased is one with significant practical, ethical and logistic implications. Here we comment on an article advocating a paradigm change in the so-called "dead donor rule". Such change would involve the societal and legal abandonment of the above rule and the introduction of mandated choice. In this commentary, we review some of the problems associated with the proposed changes as well as the problems associated with the current model. We emphasize the continuing problems with the definition of death and the physiological process of dying; we discuss the difficulties associated with a dichotomous view of death; we review the difficulties with non-beating heart donation and emphasize the current limitations of society's understanding of these complex issues. We conclude that public education remains the best approach and that such education should not be merely promotion of a particular ideology but honest debate of what is socially and morally acceptable and appropriate given the changes in vital organ support technology and the need to respect patient autonomy.     

Truthfulness in transplantation: non-heart-beating organ donation

The current practice of organ transplantation has been criticized on several fronts. The philosophical and scientific foundations for brain death criteria have been crumbling. In addition, donation after cardiac death, or non-heartbeating-organ donation (NHBD) has been attacked on grounds that it mistreats the dying patient and uses that patient only as a means to an end for someone else's benefit.     

Organ Donation After Death — Should I Decide,or Should My Family?

Who should decide about organ donation after death, the individual or the family? This paper examines why this practical question can be difficult to resolve. A comparison is made between standard decision-making in medicine and decision-making about organ donation. The questions are raised of the connection of the dead body to the person, and of who properly has autonomous control over the dead body. To understand the issues, an exploration of autonomy is needed, but at the same time this shows that a resolution depends on addressing complex spiritual and cultural issues, and questions about the autonomy of the individual versus that of the group.     

When is the gift given? Organ donation,social representations,and an opportunity to register

The gift of life doctrine underpins Australia's approach to organ donation: in legislation, clinical practice, community awareness campaigns, and educational activities. In this paper, we present an approach that situates an understanding of organ donation within a social representation framework as a system of values, ideas, and practices. In cadaveric donation, the final giving‐of‐the‐gift can never be by the donor, leading us to ask where the potential donor's decision to give the gift really lies. We present research from three studies that explored the relationship between what was socially understood about organ donation and the registration of donation intent. Drawing from three socially and culturally diverse populations, we asked people working in a corporate city institution and those attending two football matches in the outer city area to complete a word‐association task and Likert‐scale belief questions about organ donation—followed by an opportunity to register immediately on the Australian Organ Donor Register. Driven by the interdependent themata of life/death and self/other, the gift of life doctrine is inextricably linked with the loss of life emerging as both positive and negative beliefs allowing their relationship to actual registration behaviour to be observed. Our findings suggest that in many instances, the potential donor's genuine desire to give the gift lies in the tension between positive and negative beliefs, manifesting as a consent registration when the positive beliefs about donation prevail and an immediate opportunity to register is available.     

Marketing human organs: The autonomy paradox

The severe shortage of organs for transplantation and the continual reluctance of the public to voluntarily donate has prompted consideration of alternative strategies for organ procurement. This paper explores the development of market approaches for procuring human organs for transplantation and considers the social and moral implications of organ donation as both a “gift of life” and a “commodity exchange.” The problematic and paradoxical articulation of individual autonomy in relation to property rights and marketing human body parts is addressed. We argue that beliefs about proprietorship over human body parts and the capacity to provide consent for organ donation are culturally constructed. We contend that the political and economic framework of biomedicine, in western and non-western nations, influences access to transplantation technology and shapes the form and development of specific market approaches. Finally, we suggest that marketing approaches for organ procurement are and will be negotiated within cultural parameters constrained by several factors: beliefs about the physical body and personhood, religious traditions, economic conditions, and the availability of technological resources.     

The Pastor and Bioethics

This essay presents bioethics or ethics in health care as a challenge to pastors. Common professional struggles are experienced by pastoral and health professionals. Thus, first, we need to consider the meaning of being a professional especially as pastors. Second, pastors might explore at least four specific medical issues: namely physician-assisted death or euthanasia, complementary or alternative treatments, the exercise of consent to medical procedures by patients or parishioners and families, and the crucial need for the donation of vital organs to save lives. Embedded within all four issues, there is a significant religious concern which requires the pastor's expertise.     

我国人体器官捐赠移植立法问题研究

通过对我国人体器官捐赠移植立法的必要性和立法模式问题,以及我国人体器官捐赠移植法的体系和基本原则进行深入研究,指出我国人体器官捐赠移植立法宜采用统一立法模式,并遵循知情同意、人民健康第一、效用与公平、规范程序与便于操作、违法必究五项原则。     

Real Donors, Real Consent: Testing the Theory of Reasoned Action on Organ Donor Consent

In an attempt to apply the theory of reasoned action (TRA) to the process underlying organ donor consent, participants completed questionnaires concerning their affective responses to organ donation, as well as their intentions to donate. Participants were given the opportunity to sign an organ donor card. Those who chose to sign the card had more positive attitudes about donation, perceived donation as something that their reference group would encourage, and had stronger intentions to consent to signing a card. The current investigation extends the organ donor literature by using a true behavioral outcome measure indicating consent. Moreover, the pattern of results between attitudes, norms, intention, and behavior illustrates the usefulness of applying the TRA to yet another health-related behavior.     

When are you dead enough to be a donor? Can any feasible protocol for the determination of death on circulatory criteria respect the dead donor rule?

The basic question concerning the compatibility of donation after circulatory death (DCD) protocols with the dead donor rule is whether such protocols can guarantee that the loss of relevant biological functions is truly irreversible. Which functions are the relevant ones? I argue that the answer to this question can be derived neither from a proper understanding of the meaning of the term “death” nor from a proper understanding of the nature of death as a biological phenomenon. The concept of death can be made fully determinate only by stipulation. I propose to focus on the irreversible loss of the capacity for consciousness and the capacity for spontaneous breathing. Having accepted that proposal, the meaning of “irreversibility” need not be twisted in order to claim that DCD protocols can guarantee that the loss of these functions is irreversible. And this guarantee does not mean that reversing that loss is either conceptually impossible or known to be impossible with absolute certainty.

     

Death and organ procurement: public beliefs and attitudes

Although "brain death" and the dead donor rule--i.e., patients must not be killed by organ retrieval--have been clinically and legally accepted in the U.S. as prerequisites to organ removal, there is little data about public attitudes and beliefs concerning these matters. To examine the public attitudes and beliefs about the determination of death and its relationship to organ transplantation, 1351 Ohio residents >18 years were randomly selected and surveyed using random digit dialing (RDD) sample frames. The RDD telephone survey was conducted using computer-assisted telephone interviews. The survey instrument was developed from information provided by 12 focus groups and a pilot study of the questionnaire. Three scenarios based on hypothetical patients were presented: "brain dead," in a coma, or in a persistent vegetative state (PVS). Respondents provided personal assessments of whether the patient in each scenario was dead and their willingness to donate that patient's organs in these circumstances. More than 98 percent of respondents had heard of the term "brain death," but only one-third (33.7%) believed that someone who was "brain dead" was legally dead. The majority of respondents (86.2%) identified the "brain dead" patient in the first scenario as dead, 57.2 percent identified the patient in a coma as dead (Scenario 2), and 34.1 percent identified the patient in a PVS as dead (Scenario 3). Nearly one-third (33.5%) were willing to donate the organs of patients they classified as alive for at least one scenario, in seeming violation of the dead donor rule. Most respondents were not willing to violate the dead donor rule, although a substantial minority was. However, the majority of respondents were unaware, misinformed, or held beliefs there were not congruent with current definitions of "brain death." This study highlights the need for more public dialogue and education about "brain death" and organ donation.     

Cognitive obstacles against organ donation: The influence of negative attitudes,norms, and traditional beliefs on Chinese people's intention to donate organs after death

In China, the organ supply is severely insufficient to cover all people on the waiting list for donated organs, and numerous patients die awaiting transplant. To achieve a better understanding of cadaveric organ donation in Chinese culture, this study examined 300 Chinese adults, in both Fujian Province and Macao, regarding attitudes towards organ donation, subjective norms about organ donation and traditional beliefs about the body and death, examining the influences of these factors on respondents' donation intentions. Multiple hierarchical regression results suggest that more negative attitudes, unfavourable norms and traditional beliefs lead to lower donation intentions. Copyright © 2010 John Wiley & Sons, Ltd.     

<Emphasis Type="Italic">Darurah</Emphasis> (Necessity) and Its Application in Islamic Ethical Assessment of Medical Applications: A Review on Malaysian Fatwa

The discovery and invention of new medical applications may be considered blessings to humankind. However, some applications which might be the only remedy for certain diseases may contain ingredients or involve methods that are not in harmony with certain cultural and religious perspectives. These situations have raised important questions in medical ethics; are these applications completely prohibited according to these perspectives, and is there any room for mitigation? This paper explores the concept of darurah (necessity) and its deliberation in the formulation of fatwas on medicine issued by the National Fatwa Council of Malaysia. Darurah has explicitly been taken into consideration in the formulation of 14 out of 45 fatwas on medicine thus far, including one of the latest fatwas regarding uterine donation and transplantation. These fatwas are not only limited to the issues regarding the use of unlawful things as remedies. They include issues pertaining to organ transplantation, management of the corpse and treatment of brain dead patients. While deliberation of darurah in medicine may vary from issue to issue, darurah applies in a dire situation in which there are no lawful means to prevent harm that may be inflicted upon human life. Nevertheless, other aspects must also be taken into the deliberation. For example, consent must be obtained from the donor or his next of kin (after his death) to conduct a cadaveric organ transplantation.     

Can Consent be Presumed?

Opt‐out systems of postmortal organ procurement are often referred to as ‘presumed consent’ systems. A presumption directs us, in a case in which no compelling evidence is available to hold that P, nevertheless to proceed as if P were true, unless there is sufficient evidence that it is false. It is recommended to presume consent in this case, because, in the absence of registered objections of the deceased, it is held to be more probable that she consented than that she did not. Whether this suggestion makes sense, however, turns out to depend on the proper interpretation of the concept of ‘consent’. On a mental state conception of consent we are allowed to presume it if we have reason to suppose the deceased to have been in favour of donation. However, we should rather understand consent to be a public action of authorisation. On that view consent cannot be presumed, and the opt‐out systems as we presently know them on the European continent and elsewhere do not satisfy the requirement that the deceased should have consented to the removal of his organs.     

Organ donation terminology: are we communicating life or death?

The continued functioning of organ transplantation depends on obtaining the permission of the next of kin. This communication process between medical or transplant professionals and a donor family hinges heavily on the understanding of certain critical terms like brain dead, life support, and transplantation. Communication issues in obtaining organ donation consent were examined, with particular focus on what are literally life-and-death decisions. Using an experimental simulation methodology, data are offered in support of the claim that much miscommunication occurs in such situations. Directions for improving such communication by allaying latent fears and more carefully defining crucial terminology are offered.