An ethical and legal framework is needed to regulate the rapidly developing human brain organoid research field properly. However, considering the legal issues involved in human brain organoid research remains underdeveloped and scattered. This article reviews the legal issues of human brain organoid research, grouping them into the following five broad themes: (1) consciousness, (2) legal status, (3) consent, (4) ownership, and (5) transplantation. The issues in each topic include both the urgent (e.g., appropriate forms of consent) and the speculative (...) (e.g., protection of conscious human brain organoids). Therefore, we have attempted to be as explicit as possible about the timescale within which each issue will be realized and to prioritize each. Examining these issues has revealed legal issues specific to human brain organoid research and issues common to research in other fields. Further discussion of human brain organoid research from a legal perspective is needed in the future, considering discussions in related fields. (shrink)

Organ donation after the circulatory determination of death requires the permanent cessation of circulation while organ donation after the brain determination of death requires the irreversible cessation of brain functions. The unified brain-based determination of death connects the brain and circulatory death criteria for circulatory death determination in organ donation as follows: permanent cessation of systemic circulation causes permanent cessation of brain circulation which causes permanent cessation of brain perfusion which causes permanent cessation of brain function. The relevant circulation that (...) must cease in circulatory death determination is that to the brain. Eliminating brain circulation from the donor ECMO organ perfusion circuit in thoracoabdominal NRP protocols satisfies the unified brain-based determination of death but only if the complete cessation of brain circulation can be proved. Despite its medical and physiologic rationale, the unified brain-based determination of death remains inconsistent with the Uniform Determination of Death Act. (shrink)

Looking to Scripture through the eyes of contemporary medical experience, I analyze the meaning of the criteria used for determining death, specifically in the light of Jesus’ final moments and the resurrection of the Shunammite’s son in 2 Kings, chapter 4. I argue that four theses are consistent with, and informed by, these passages that can help guide Christian belief and decision-making about how death is determined in the clinical context: (1) death is neither permanent nor irreversible; (2) something like (...) the “brain dead” state is, at best, a confounding state that requires one to “pace and pray” or let go; (3) that the case for determining death by neurologic criteria depends on the “working togetherness” of the body's parts for the sake of impacting its environment; and (4) that the practice of neurologically-based death determination is a response to the problem of disaggregation of the human form into its organ systems that modern critical care medicine makes possible. I end with advice about how Christians might approach the debates over the law and practice even if they cannot come to a consensus. (shrink)

Plans to attempt what has been called a head transplant, a body transplant, and a head-to-body transplant in human beings raise numerous ethical, social, and legal questions, including the circumstances, if any, under which it would be ethically permissible to attempt whole-body transplantation (WBT) in human beings, the possible effect of WBT on family relationships, and how families should shape WBT decisions. Our assessment of many of these questions depends partially on how we respond to sometimes centuries-old philosophical thought experiments (...) about personal identity. As with so much in bioethics, it is impossible to escape, or at least inadvisable to try to bypass, the relevant foundational philosophical concerns. (shrink)

I defend the position argued previously by Germain Grisez and me that total brain death is a valid criterion of death on the grounds that a human being is essentially a rational animal, and a brain-dead body lacks the radical capacity for rational actions. I reply to Josef Seifert’s objection that our positions rest on a reductionist view of the human person, and to other objections concerning the inter-relation between the human soul, its powers, and functions of the brain. I (...) argue that a brain-dead body lacks the material dispositions needed for having the form or soul of a human being. (shrink)

This is the third installment in a Christian Bioethics series that gathers leading voices in Christian bioethics to examine the themes and issues they find most pressing. The papers address fundamental theoretical questions about the nature of Christian bioethics itself, long-standing ethical issues that remain significant today, including physician-assisted suicide, euthanasia, the definition of death, the allocation of scarce resources, and finally, more futuristic questions regarding transhumanism. The contributions underscore the enduring significance of Christian engagement in bioethics.

Psychological accounts of personal identity claim that the human person is not identical to the human animal. Advocates of such accounts maintain that the definition and criterion of death for a human person should differ from the definition and criterion of death for a human animal. My contention is instead that psychological accounts of personal identity should have human persons dying deaths that are defined biologically, just like the deaths of human animals. Moreover, if brain death is the correct criterion (...) for the death of a human animal, then it is also the correct criterion for the death of a human person. What the nonidentity of persons and animals requires is only that they have distinct criteria for ceasing to exist. (shrink)

Although death statutes permitting physicians to declare brain death are relatively uniform throughout the United States, academic debate persists over the equivalency of human death and brain death. Alan Shewmon showed that the formerly accepted integration rationale was conceptually incomplete by showing that brain-dead patients demonstrated a degree of integration. We provide a more complete rationale for the equivalency of human death and brain death by defending a deeper understanding of the organism as a whole and by using a novel (...) strategy with shared objectives to justify death determination criteria. Our OaaW account describes different types of OaaW, defining human death as the loss of status as a human OaaW. We defend human death as similar to nonhuman death in terms of wakefulness, but also distinct in terms of the sui generis properties, particularly conscious awareness. We thereby defend the equivalency of brain death and human death using a resulting neurocentric rationale. (shrink)

The biophilosophic justification for the idea that “brain death” is death needs to support two claims: that what dies in human death is a human organism, not merely a psychological entity distinct from it; that total brain failure signifies the end of the human organism as a whole. Defenders of brain death typically assume without argument that the first claim is true and argue for the second by defending the “integrative unity” rationale. Yet the integrative unity rationale has fallen on (...) hard times. In this article, I give reasons for why we should think of ourselves as organisms, and why the “fundamental work” rationale put forward by the 2008 President’s Council is better than the integrative unity rationale, despite persistent objections to it. (shrink)

Humans often seek to improve themselves, whether through self-discipline or through the use of science and technology. At some point in the future, techniques might become available that will change humans to such a degree that they might have to be regarded as something other than human: posthuman. This essay tries to define the point at which such a human-to-posthuman metamorphosis may occur. This is achieved by discerning what is it that makes human substance distinct, i.e. what is the human (...) essence. This is accomplished by examining the features of the human body, looking at the mode of human existence in society and trying to grasp the importance of the body–soul relationship. Throughout the process, humans are compared to animals as well as entities from literature, film, and the gaming world. These are used as case studies to shape and test the ideas developed throughout the essay. This essay's conclusions might become useful when decisions will have to be made as to the legal status of posthumans,... (shrink)

This paper aims to determine whether it is necessary to propose the extreme of putrefaction as the only unmistakable sign in diagnosing the death of the human organism, as David Oderberg does in a recent paper. To that end, we compare Oderberg’s claims to those of other authors who align with him in espousing the so-called theory of hylomorphism but who defend either a neurological or a circulatory-respiratory criterion for death. We then establish which interpretation of biological phenomena is the (...) most reasonable within the metaphysical framework of hylomorphism. In this regard, we hold that technology does not obscure the difference between life and death or confect metaphysically anomalous beings, such as living human bodies who are not organisms or animals of the human species who are informed by a vegetative soul, but instead demands a closer and more careful look at the “fuzzy area” between a healthy organism and a decaying corpse. In the light of hylomorphism, we conclude that neurological and circulatory-respiratory criteria are not good instruments for diagnosing death, since they can offer only probabilistic prognoses of death. Of the two, brain death is further away from the moment of death as it merely predicts cardiac arrest that will likely result in death. Putrefaction, the criterion that Oderberg proposes, is at the opposite end of the fuzzy area. This is undoubtedly a true diagnosis of death, but it is not necessary to wait for putrefaction proper—a relatively late stage of decomposition—to be sure that death has already occurred. Rather, early cadaveric phenomena demonstrate that the matter composing a body is subject to the basic forces governing all matter in its environment and has thus succumbed to the universal current of entropy, meaning that the entropy-resisting activity has ceased to constitute an organismal unity. When this unity is lost, there is no possibility of return. (shrink)

For decades, physicians, philosophers, theologians, lawyers, and the public considered brain death a settled issue. However, a series of recent cases in which individuals were declared brain dead yet physiologically maintained for prolonged periods of time has challenged the status quo. This signals a need for deeper reflection and reexamination of the underlying philosophical, scientific, and clinical issues at stake in defining death. In this paper, I consider four levels of philosophical inquiry regarding death: the ontological basis, actual states of (...) affairs, epistemological standards, and clinical criteria for brain death. I outline several candidates for the states of affairs that may constitute death, arguing that we should strive for a single, unified ontological definition of death as a loss of integrated functioning as a unified organism, while acknowledging that two states of affairs may satisfy this concept. I argue that the clinical criteria for determining whole-brain death should be bolstered to meet the epistemic demand of sufficient certainty in defining death by adding indicators of cerebro-somatic dis-integration to the traditional triad of loss of consciousness, loss of brainstem function, and absence of confounding explanations. (shrink)

The basic question concerning the compatibility of donation after circulatory death 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. (shrink)

In the ongoing ‘brain death’ controversy, there has been a constant push for the use of the ‘higher brain’ formulation as the criterion for the determination of death on the grounds that brain-dead individuals are no longer human beings because of their irreversible loss of consciousness and mental functions. This essay demonstrates that such a position flows from a Lockean view of human persons. Compared to the ‘consciousness-related definition of death,’ the substance view is superior, especially because it provides a (...) holistic vision of the human person, and coheres with the perennial axiom about the ‘whole and parts.’. (shrink)

I develop and refine an argument for the total brain death criterion of death previously advanced by Germain Grisez and me: A human being is essentially a rational animal, and so must have a radical capacity for rational operations. For rational animals, conscious sensation is a pre-requisite for rational operation. But total brain death results in the loss of the radical capacity for conscious sensation, and so also for rational operations. Hence, total brain death constitutes a substantial change—the ceasing to (...) be of the human being. Objections are considered, including the objection that total brain death need not result in the loss of capacity for sensation, and that damage to the brain less than total brain death can result in loss of capacity for rational operations. (shrink)

Human life is operationally defined by the onset and cessation of organismal function. At postnatal stages of life, organismal integration critically and uniquely requires a functioning brain. In this article, a distinction is drawn between integrated and coordinated biologic activities. While communication between cells can provide a coordinated biologic response to specific signals, it does not support the integrated function that is characteristic of a living human being. Determining the loss of integrated function can be complicated by medical interventions that (...) uncouple elements of the natural biologic hierarchy underlying our intuitive understanding of death. Such medical interventions can allow living human beings who are no longer able to function in an integrated manner to be maintained in a living state. In contrast, medical intervention can also allow the cells and tissues of an individual who has died to be maintained in a living state. To distinguish between a living human being and living human cells, two criteria are proposed: either the persistence of any form of brain function or the persistence of autonomous integration of vital functions. Either of these criteria is sufficient to determine a human being is alive. (shrink)

The mainstream concept of death—the biological one—identifies death with the cessation of an organism. In this article, I challenge the mainstream position, showing that there is no single well-established concept of an organism and no universal concept of death in biological terms. Moreover, some of the biological views on death, if applied in the context of bedside decisions, might imply unacceptable consequences. I argue the moral concept of death—one similar to that of Robert Veatch—overcomes such difficulties. The moral view identifies (...) death with the irreversible cessation of a patient’s moral status, that is, a state when she can no longer be harmed or wronged. The death of a patient takes place when she is no longer capable of regaining her consciousness. In this regard, the proposal elaborated herein resembles that of Veatch yet differs from Veatch’s original project since it is universal. In essence, it is applicable in the case of other living beings such as animals and plants, provided that they have some moral status. (shrink)

According to the mainstream position in the bioethical definition of death debate, death is to be equated with the cessation of an organism. Given such a perspective, some bioethicists uphold the position that brain-dead patients are dead, while others claim that they are alive. Regardless of the specific opinion on the status of brain-dead patients, the mere bioethical concept of death, according to many bioethicists, has the merit of being unanimous and univocal, as well as grounded in biology. In the (...) present article, we challenge such a thesis. We provide evidence that theoretical biology operates with a plurality of equally valid organismic concepts, which imply different conclusions regarding the organismal status of a brain-dead patient. Moreover, the theoretical biology concepts of an organism are very distant from the view on an organism that appears by way of bioethicists theorizing on death. We conclude that if death is to be understood as the cessation of an organism, there is no single correct answer to the question of whether a brain-dead patient is alive or dead. (shrink)

Several bioethicists have recently discussed the complexity of defining human death, and considered in particular how our definition of death affects our understanding of the ethics of vital organ procurement. In this brief paper, we challenge the mainstream medical definition of human death—namely, that death is equivalent to total brain failure—and argue with Nair-Collins and Miller that integrated biological functions can continue even after total brain failure has occurred. We discuss the implications of Nair-Collins and Miller’s argument and suggest that (...) it may be necessary to look for alternative biological markers that reliably indicate the death of a human being. We reject the suggestion that we should abandon the dead-donor criteria for organ donation. Rather than weaken the ethical standards for vital organ procurement, it may be necessary to make them more demanding. The aim of this paper is not to justify the dead donor rule. Rather, we aim to explore the perspective of those who agree with critiques of the whole brain and cardiopulmonary definitions of death but yet disagree with the proposal that we should abandon the dead-donor rule. We will consider what those who want to retain the dead-donor rule must argue in light of Nair-Collins and Miller’s critique. (shrink)

John P. Lizza has long been a major figure in the scholarly literature on criteria for death. His searching and penetrating critiques of the dominant biological paradigm, and his defense of a theory of death of the person as a psychophysical entity, have both significantly advanced the literature. In this special issue, Lizza reinforces his critiques of a strictly biological approach. In my commentary, I take up Lizza’s challenge regarding a biological concept of death. He is certainly right to point (...) out that science is not value-free; however, this does not imply that there cannot be a characterization of biological death that can be shown to be superior to other concepts. After characterizing and justifying such a theory of biological death, I show that patients who meet the diagnostic criteria for brain death are unequivocally biologically alive. However, with respect to concepts of personhood and related ideas, I urge the acceptance of a pluralism of such concepts for matters of public policy. (shrink)

The established view regarding ‘brain death’ in medicine and medical ethics is that patients determined to be dead by neurological criteria are dead in terms of a biological conception of death, not a philosophical conception of personhood, a social construction or a legal fiction. Although such individuals show apparent signs of being alive, in reality they are dead, though this reality is masked by the intervention of medical technology. In this article, we argue that an appeal to the distinction between (...) appearance and reality fails in defending the view that the ‘brain dead’ are dead. Specifically, this view relies on an inaccurate and overly simplistic account of the role of medical technology in the physiology of a ‘brain dead’ patient. We conclude by offering an explanation of why the conventional view on ‘brain death’, though mistaken, continues to be endorsed in light of its connection to organ transplantation and the dead donor rule. (shrink)

Although the term integration is central to the definition of brain death, there is little agreement on what it means. Through a genealogical analysis, this essay argues that there have been two primary ways of understanding integration in regard to organismal wholeness. One stems from neuroscience, focusing on the role of the brain in responding to external stimuli, which was taken up in phenomenological accounts of life. A second, arising out of cybernetics, focuses on the brain’s role in homeostasis. Recent (...) debates over brain death are largely over this cybernetic understanding of integration. However, the phenomenological understanding of organismal wholeness can be seen in arguments by the President’s Council on Bioethics in favor of brain death. This essay argues that the cybernetic understanding of life is problematic and should be discarded. A phenomenological understanding of life can provide a better basis for arguments over definitions of life and death. (shrink)

The breadth of themes addressed in this issue of the Journal of Medicine and Philosophy is striking. These articles brim with some of the most foundational questions one can ask in bioethics and the philosophy of medicine: Under what circumstances might we risk some harm in pursuit of a greater good? In the setting of experimental therapies, how should we weigh the potential risk and benefit for an individual patient against the broader potential benefit realized for society as a whole? (...) How might we consistently differentiate health from pathology? Under what circumstances might we say that a human being has died? Does acknowledging particular things as good generate duties? Duties for whom and enforced by whom? These articles share a preoccupation with foundational questions that must be addressed in any sound bioethics curriculum, and they make clear that our answers to these questions are not simply theoretical but manifest in policy and in practice. (shrink)

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. (shrink)

In this paper, I argue that brain death is death because, despite the appearance of genuine integration, the brain-dead body does not in fact possess the unity that is proper to a human organism. A brain-dead body is not a single entity, but a multitude of organs and tissues functioning in a coordinated manner with the help of artificial life support. In order to support this claim, I first lay out Hoffmann and Rosenkrantz’s ontological account of the requirements for organismal (...) unity and summarize an earlier paper in which I apply this account to the brain death debate. I then further support this ontological argument by developing an analogy between the requirements for the unity of an organism and the requirements for the unity of an orchestra. To do so, I begin by examining the role that a conductor plays in unifying a traditional orchestra, and then go on to show that the human organism functions like a traditional orchestra that relies upon a conductor for its unity. Next, I consider the conditions required to achieve orchestral unity in conductorless orchestras and show that, in contrast to simpler organisms like plants, the postnatal human organism lacks those conditions. I argue, in other words, that although conductorless orchestras do exist, the human organism is not one of them. Like a traditional orchestra without a conductor, the brain-dead body is not a unified whole. (shrink)