Maxwell J. Smith

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.

Casting Light and Doubt on Uncontrolled DCDD Protocols

The ever-increasing demand for organs led Spain, France, and other European countries to promote uncontrolled donation after circulatory determination of death (uDCDD). For the same reason, New York City has recently developed its own uDCDD protocol, which differs from European programs in some key ways. The New York protocol incorporates a series of technical and management improvements that address some practical problems identified in response to European uDCDD protocols. However, the more fundamental issue of whether uDCDD donors are dead when organs are procured remains problematic for the New York City protocol and, indeed, for all uDCDD protocols. In the United States, two amendments to the legal criteria of death have been suggested to avoid a formal violation of the dead donor rule in DCDD protocols: first, replacing the requirement “irreversible” with the weaker term “permanent,” and second, using the term “circulatory” instead of “cardiac” to identify the key function that must be lost to declare death. While intended to facilitate controlled DCDD, these modifications create a problem for uDCDD protocols: if extracorporeal membrane oxygenation is introduced to preserve the organs, then circulation is restored after death is declared. In this issue of the Hastings Center Report, Kevin Munjal and colleagues call for a new ethical construct and policy so that uncontrolled and controlled DCDD can coexist.

Ebola and Learning Lessons from Moral Failures: Who Cares about Ethics?

Abstract The exercise of identifying lessons in the aftermath of a major public health emergency is of immense importance for the improvement of global public health emergency preparedness and response. Despite the persistence of the Ebola Virus Disease (EVD) outbreak in West Africa, it seems that the Ebola ‘lessons learned’ exercise is now in full swing. On our assessment, a significant shortcoming plagues recent articulations of lessons learned, particularly among those emerging from organizational reflections. In this article we argue that, despite not being recognized as such, the vast majority of lessons proffered in this literature should be understood as ethical lessons stemming from moral failures, and that any improvements in future global public health emergency preparedness and response are in large part dependent on acknowledging this fact and adjusting priorities, policies and practices accordingly such that they align with values that better ensure these moral failures are not repeated and that new moral failures do not arise. We cannot continue to fiddle at the margins without critically reflecting on our repeated moral failings and committing ourselves to a set of values that engenders an approach to global public health emergencies that embodies a sense of solidarity and global justice.

Ethics for pandemics beyond influenza: Ebola, drug-resistant tuberculosis, and anticipating future ethical challenges in pandemic preparedness and response.

The unprecedented outbreak of Ebola virus disease (EVD) in West Africa has raised several novel ethical issues for global outbreak preparedness. It has also illustrated that familiar ethical issues in infectious disease management endure despite considerable efforts to understand and mitigate such issues in the wake of past outbreaks. To improve future global outbreak preparedness and response, we must examine these shortcomings and reflect upon the current state of ethical preparedness. To this end, we focus our efforts in this article on the examination of one substantial area: ethical guidance in pandemic plans. We argue that, due in part to their focus on considerations arising specifically in relation to pandemics of influenza origin, pandemic plans and their existing ethical guidance are ill-equipped to anticipate and facilitate the navigation of unique ethical challenges that may arise in other infectious disease pandemics. We proceed by outlining three reasons why this is so, and situate our analysis in the context of the EVD outbreak and the threat posed by drug-resistant tuberculosis: (1) different infectious diseases have distinct characteristics that challenge anticipated or existing modes of pandemic prevention, preparedness, response, and recovery, (2) clear, transparent, context-specific ethical reasoning and justification within current influenza pandemic plans are lacking, and (3) current plans neglect the context of how other significant pandemics may manifest. We conclude the article with several options for reflecting upon and ultimately addressing ethical issues that may emerge with different infectious disease pandemics.

Disadvantaging the disadvantaged: When public health policies and practices negatively affect marginalized populations.

Public health is intimately related to social justice, which is why practice and research in the field seek to improve the social determinants of health. Despite the best intentions of those working in public health, however, some policies and practices inadvertently further disadvantage pre-existing marginalized populations. In this paper, we provide a diagnosis of possible reasons why this phenomenon might occur. We posit that the challenges associated with further marginalizing certain populations stem from a) not acknowledging the normative aspects of apparently objective data, b) a misunderstanding and an uncritical alignment of public health goals with the ethics theory of utilitarianism, and c) assuming that those working in public health might be able to fully understand the experiences of marginalized populations. It is our view that the trend of public consultation with marginalized persons, the explicit teaching of ethics and philosophy of science in graduate departments of public health, and the increased use of health equity impact assessments might help protect against public health policies and practices that disadvantage marginalized populations.RésuméLa santé publique est intimement liée à la justice sociale, ce qui explique pourquoi la pratique et la recherche sur le terrain visent à améliorer les déterminants sociaux de la santé. Malgré les meilleures intentions des personnes qui travaillent en santé publique toutefois, certaines politiques et pratiques défavorisent encore davantage, sans le vouloir, des populations déjà marginalisées. Dans cet article, nous diagnostiquons les raisons possibles d’un tel phénomène. Nous faisons valoir que les difficultés associées à la marginalisation accrue de certaines populations découlent: a) de la non-reconnaissance des aspects normatifs de données apparemment objectives, b) d’une méconnaissance des objectifs de santé publique et de leur réglage sans discernement sur la théorie éthique de l’utilitarisme et c) de l’hypothèse selon laquelle les personnes qui travaillent en santé publique pourraient être capables de comprendre pleinement les expériences de populations marginalisées. Nous considérons que la tendance à la consultation publique des personnes marginalisées, l’enseignement explicite de l’éthique et de la philosophie de la science dans les départements d’études supérieures en santé publique et l’utilisation accrue des évaluations de l’impact sur l’équité en matière de santé pourraient être des mesures de protection contre les politiques et les pratiques sanitaires qui défavorisent les populations marginalisées.

Ethical considerations in post-market-approval monitoring and regulation of vaccines

The objective of this paper is to identify and articulate ethical considerations to help guide decision-making around the regulation and monitoring of vaccines post-licensure. While these considerations are not intended to be an exhaustive account of the ethical concerns, they can facilitate the explicit examination of ethical issues in this context. We identify the protection of public from harm as the primary consideration, and identify others that help in the discharging of this governmental obligation. Others include: transparency, a publicly acceptable risk-benefit profile, public trust, minimization of stigma, and special obligations to vulnerable populations. Regulators and researchers can use these ethical considerations to help enhance their reasoning and to improve the accountability of their decision-making. These considerations can be used to inform rational deliberations about how to balance the obligation to protect the public from harm with other relevant considerations such as the need to be transparent, while taking into account the contextual features of the situation. Further research and debate on the relevance and refinement of these ethical considerations is desirable.

“With Human Health It’s a Global Thing”: Canadian Perspectives on Ethics in the Global Governance of an Influenza Pandemic

We live in an era where our health is linked to that of others across the globe, and nothing brings this home better than the specter of a pandemic. This paper explores the findings of town hall meetings associated with the Canadian Program of Research on Ethics in a Pandemic (CanPREP), in which focus groups met to discuss issues related to the global governance of an influenza pandemic. Two competing discourses were found to be at work: the first was based upon an economic rationality and the second upon a humanitarian rationality. The implications for public support and the long-term sustainability of new global norms, networks, and regulations in global public health are discussed.

Uncontrolled Donation After Circulatory Determination of Death Protocols: Ethical Challenges and Suggestions for Improvement

To the Editor: Although uncontrolled donation after circulatory determination of death protocols can save and improve the lives of thousands of individuals, they pose ethical, clinical, and logistical challenges. We raise here 3 concerns about these protocols and propose suggestions for improvement. In some uncontrolled donation after circulatory determination of death donors, in whom organ preservation measures have been initiated after a failed attempt at cardiopulmonary resuscitation, a return of spontaneous circulation and significant neurologic recovery have been reported. Moreover, selected patients who experience out-of-hospital cardiac arrests and for whom ordinary resuscitation efforts have failed can benefit from continuing resuscitation as a bridge to nonconventional procedures that treat the cause of the out-of-hospital cardiac arrest while preserving neurologic function. If they fail to offer certain lifesaving interventions to such patients, uncontrolled donation after circulatory determination of death protocols might include individuals who may have a chance of meaningful survival. We support that “protocols must instill faith that all life-sustaining measures [have been] exhausted” and “[a]ll resuscitations . . . meet the highest standards.” In European protocols, the EMS team who failed to resuscitate the individual initiates organ preservation measures before he or she is officially declared dead. However, the measures should be “initiated by a member of the organ transplant team rather than the emergency provider” to avoid a conflict of loyalties between the care of the patient and the interests of organ recipients. This measure has been d

Conceptualizing the “Self” in Neuroethics: An Appeal to Philosophy of Mind

The ontological and metaphysical status of the “self” and self-identity involves contentious debate in philosophy of mind and has great implications in neuroscience and neuroethics. Indeed, contemporary conceptions regarding selfidentity may have significant impact on the practice of medicine and bioethics, particularly surrounding the moral considerations for individuals in compromised or diminished states of consciousness and for those affected by neuropsychiatric treatments. It is thus appreciated that Anderson-Shaw and colleagues (2010) have sparked a discussion regarding the conception and role of the “self” and self-identity in medicine, particularly in relation to our ethical response to the clinical dysfunction of these concepts. Anderson-Shaw and colleagues ask us whether we lose our “self” if we can no longer remember our past or have the ability to plan for our future, or if there is dissonance between our present experience and previous conceptions of ourselves. The authors recognize the “untidy” nature of the concept of the “self”; however, I feel that without providing a clear understanding of such a concept, the implications for neuroscience and neuroethics become elusive. This is not to fault the authors, though, as these conceptions are indeed untidy, and for pragmatic reasons, some assumptions are necessary for these discussions to exist. However, as we move forward in the burgeoning field of neuroethics it will be important to thoroughly address and evaluate these assumptions. Moreover, as neuroscience, neurotechnology, and cognitive science provide us with arguments and evidence that may profoundly alter our theories regarding fundamental concepts of the “self” and self-identity, it is imperative to reflect this progress concomitantly in neuroethics. As a testament of this imperative, in the following I point to the contentious nature of the concept of the “self” and show how the invocation of such concepts in current neuroethics discourse makes presuppositions that do not represent consensus in philosophy of mind. Thus, I also suggest that, in order to adequately address such concepts in neuroethics, it will be necessary to appeal to philosophy of mind to provide insight and theoretical discussion into these foundational issues.

Systems thinking and ethics in public health: a necessary and mutually beneficial partnership

Systems thinking has emerged as a means of conceptualizing and addressing complex public health problems, thereby challenging more commonplace understanding of problems and corresponding solutions as straightforward explanations of cause and effect. Systems thinking tries to address the complexity of problems through qualitative and quantitative modeling based on a variety of systems theories, each with their own assumptions and, more importantly, implicit and unexamined values. To date, however, there has been little engagement between systems scientists and those working in bioethics and public health ethics. The goal of this paper is to begin to consider what it might mean to combine systems thinking with public health ethics to solve public health challenges. We argue that there is a role for ethics in systems thinking in public health as a means of elucidating implicit assumptions and facilitating ethics debate and dialogue with key stakeholders.