Background Requirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations (OPOs) increasingly use the Internet for organ donation consent. Methods An analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services for informed consent. Content scores (...) were calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent. Results There were 60 Web sites for organ donation enrollment serving the 52 states. The median percent (10 percentile-90 percentile) content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33% (20–47), 79% (57–86), and 75% (50–100), respectively. The informed consent score was 0% (0–33). The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites (P < .05). The content scores for the four categories were similar among the 11 regions of the United Network for Organ Sharing. Conclusion The Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent. (shrink)

Richard Thaler and Cass Sunstein (2008) contend that mandated choice is the most practical nudge for increasing organ donation. We argue that they are wrong, and their mistake results from failing to appreciate how perceptions of meaning can influence people's responses to nudges. We favor a policy of default to donation that is subject to immediate family veto power, includes options for people to opt out (and be educated on how to do so), and emphasizes the role of organ procurement (...) organizations and in-house transplant donation coordinators creating better environments for increasing the supply of organs and tissues obtained from cadavers. This policy will provide better opportunities for offering nudges in contexts where in-house coordinators work with families. We conclude by arguing that nudges can be introduced ethically and effectively into these contexts only if nudge designers collaborate with in-house coordinators and stakeholders. (shrink)

Background Requirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations increasingly use the Internet for organ donation consent. Methods An analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services for informed consent. Content scores were (...) calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent. Results There were 60 Web sites for organ donation enrollment serving the 52 states. The median percent content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33%, 79%, and 75%, respectively. The informed consent score was 0%. The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites ( P Conclusion The Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent. (shrink)

In 1968, the Harvard criteria equated irreversible coma and apnea with human death and later, the Uniform Determination of Death Act was enacted permitting organ procurement from heart-beating donors. Since then, clinical studies have defined a spectrum of states of impaired consciousness in human beings: coma, akinetic mutism, minimally conscious state, vegetative state and brain death. In this article, we argue against the validity of the Harvard criteria for equating brain death with human death. Brain death does not disrupt somatic (...) integrative unity and coordinated biological functioning of a living organism. Neurological criteria of human death fail to determine the precise moment of an organism’s death when death is established by circulatory criterion in other states of impaired consciousness for organ procurement with non-heart-beating donation protocols. The criterion of circulatory arrest 75 s to 5 min is too short for irreversible cessation of whole brain functions and respiration controlled by the brain stem. Brain -based criteria for determining death with a beating heart exclude relevant anthropologic, psychosocial, cultural, and religious aspects of death and dying in society. Clinical guidelines for determining brain death are not consistently validated by the presence of irreversible brain stem ischemic injury or necrosis on autopsy; therefore, they do not completely exclude reversible loss of integrated neurological functions in donors. The questionable reliability and varying compliance with these guidelines among institutions amplify the risk of determining reversible states of impaired consciousness as irreversible brain death. The scientific uncertainty of defining and determining states of impaired consciousness including brain death have been neither disclosed to the general public nor broadly debated by the medical community or by legal and religious scholars. Heart-beating or non-heart-beating organ procurement from patients with impaired consciousness is de facto a concealed practice of physician-assisted death, and therefore, violates both criminal law and the central tenet of medicine not to do harm to patients. Society must decide if physician-assisted death is permissible and desirable to resolve the conflict about procuring organs from patients with impaired consciousness within the context of the perceived need to enhance the supply of transplantable organs. (shrink)

No one really believes that literally all functions of the entire brain must be lost for an individual to be dead. A better definition of death involves a higher brain orientation.

The mainstream rationale for equating brain death (BD) with death is that the brain confers integrative unity upon the body, transforming it from a mere collection of organs and tissues to an organism as a whole. In support of this conclusion, the impressive list of the brains myriad integrative functions is often cited. Upon closer examination, and after operational definition of terms, however, one discovers that most integrative functions of the brain are actually not somatically integrating, and, conversely, most integrative (...) functions of the body are not brain-mediated. With respect to organism-level vitality, the brains role is more modulatory than constitutive, enhancing the quality and survival potential of a presupposedly living organism. Integrative unity of a complex organism is an inherently nonlocalizable, holistic feature involving the mutual interaction among all the parts, not a top-down coordination imposed by one part upon a passive multiplicity of other parts. Loss of somatic integrative unity is not a physiologically tenable rationale for equating BD with death of the organism as a whole. (shrink)

Presumed consent to organ donation looks increasingly unlikely to be a palatable option for increasing organ procurement in the UK following the publication of the report into events at Alder Hey and elsewhere. Yet, given that the alternative to increasing the number of cadaveric organs available is either to accept a greater number of live donations, or accept that people will continue to die for the want of an organ, public policy makers remain obliged to consider other means of increasing (...) the procurement rate.In this paper, we meet the main objections to mandated choice . We have modified the traditional approach to mandated choice to take into account the force of the objection that mandated donation is preferable, by accepting that people can and do make bad decisions about organ donation and proposing that all accompanying public education and information about cadaveric donation should be directed in favour of donation. (shrink)

Many accounts of informed consent in medical ethics claim that it is valuable because it supports individual autonomy. Unfortunately there are many distinct conceptions of individual autonomy, and their ethical importance varies. A better reason for taking informed consent seriously is that it provides assurance that patients and others are neither deceived nor coerced. Present debates about the relative importance of generic and specific consent do not address this issue squarely. Consent is a propositional attitude, so intransitive: complete, wholly specific (...) consent is an illusion. Since the point of consent procedures is to limit deception and coercion, they should be designed to give patients and others control over the amount of information they receive and opportunity to rescind consent already given. (shrink)

The controversy over brain death and the dead donor rule continues unabated, with some of the same key points and positions starting to see repetition in the literature. One might wonder whether some of the participants are talking past each other, not all debating the same issue, even though they are using the same words (e.g., “death”). One reason for this is the complexity of the debate: It’s not merely about the nature of human life and death. Interwoven into this (...) debate are deep philosophical issues on realism, the normative/descriptive distinction, the relation of thought and language to the world, the mind–body problem, personhood, moral status, and the ethics of killing. There are also social and legal .. (shrink)

“Brain death,” the determination of human death by showing the irreversible loss of all clinical functions of the brain, has become a worldwide practice. A biophilosophical account of brain death requires four sequential tasks: agreeing on the paradigm of death, a set of preconditions that frame the discussion; determining the definition of death by making explicit the consensual concept of death; determining the criterion of death that proves the definition has been fulfilled by being both necessary and sufficient for death; (...) and determining the tests of death for physicians to employ at the patient's bedside to demonstrate that the criterion of death has been fulfilled. The best definition of death is “the cessation of functioning of the organism as a whole.” The whole-brain criterion is the only criterion that is both necessary and sufficient for death. Brain death tests are used only in the unusual case in which a patient's ventilation is being supported. Brain death critics have identified weaknesses in its formulation. But despite its shortcomings, the whole-brain death formulation comprises a concept and public policy that make intuitive and practical sense and that has been well accepted by many societies. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

Expressing doubts about death criteria can serve healthy purposes, but can also cause a number of harms, including decreased organ donation rates and distress for donor families and health care staff. This paper explores the various causes of doubts about death criteria—including religious beliefs, misinformation, mistrust, and intellectual questions—and recommends responses to each of these. Some recommended responses are relatively simple and noncontroversial, such as providing accurate information. However, other responses would require significant changes to the way we currently do (...) business. Policymakers should establish minimum national standards for determining death to foster a trustworthy system; academics and publishers have a duty to publish only materials that substantially engage and advance the debate to minimize the harm caused by divided expert opinion; and opposition to the dead donor rule should be conceptually separated from doubts about death criteria. (shrink)

The concept of brain death — first defined decades ago — still presents medical, ethical, and legal challenges despite its widespread acceptance in clinical practice and in law. This article reviews the medicine, law, and ethics of brain death, including the current inconsistencies in brain death determinations, which a lack of standardized federal policy promotes, and argues that a standard brain death policy to be used by all hospitals in all states should be created.

The concept of brain death evolved because advancements in medical science permitted unprecedented artificial maintenance of vital body functions by external means. Although the concept of brain death is accepted clinically, ethically, and legally in the United States, there is no national standard for the determination of brain death. There is evidence that variability and inconsistency in the process of determining brain death exist both in clinical settings and in State statutes. Several studies demonstrate that medical personnel determine brain death (...) in variable ways, and have variable understandings of the definition of brain death. The declaration of death has significant legal consequences such as probate proceedings and liability issues for wrongful death. Inconsistencies in the determination of death may therefore be medically, ethically, and legally problematic. (shrink)

The definition of death is one of the oldest and most enduring problems in biophilosophy and bioethics. Serious controversies over formally defining death began with the invention of the positive-pressure mechanical ventilator in the 1950s. For the first time, physicians could maintain ventilation and, hence, circulation on patients who had sustained what had been previously lethal brain damage. Prior to the development of mechanical ventilators, brain injuries severe enough to induce apnea quickly progressed to cardiac arrest from hypoxemia. Before the (...) 1950s, the loss of spontaneous breathing and heartbeat were perfect predictors of death because the functioning of the brain and of all other organs ceased rapidly and nearly simultaneously thereafter, producing a unitary death phenomenon. In the pretechnological era, physicians and philosophers did not have to consider whether a human being who had lost certain “vital functions” but had retained others was alive, because such cases were technically impossible. (shrink)

The practice of obtaining informed consent has its history in, and gains its meaning from, medicine and biomedical research. Discussions of disclosure and justified nondisclosure have played a significant role throughout the history of medical ethics, but the term “informed consent” emerged only in the 1950s. Serious discussion of the meaning and ethics of informed consent began in medicine, research, law, and philosophy only around 1972.

Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

The book challenges the values of much of contemporary bioethics and health care policy by confronting their failure to secure the moral norms they seek to apply.

This review essay examines H. Tristram Engelhardt, Jr.'s The Foundations of Bioethics, a contemporary nonfeminist text in mainstream biomedical ethics. It focuses upon a central concept, Engelhardt's idea of the moral community and argues that the most serious problem in the book is its failure to take account of the political and social structures of moral communities, structures which deeply affect issues in biomedical ethics.