There has been considerable debate over regulated organ markets. Especially current markets, where people sell one of their kidneys while still alive, have received increased attention. Futures markets remain an interesting and under-discussed alternative specification of a market-based solution to the organ shortage. Futures markets pertain to the sale of the right to procure people’s organs after they die. There is a wide range of possible specifications of the futures market. There are, however, some major unaddressed efficiency concerns. This article (...) presents this class of concerns and discusses the implication for organ futures markets. It identifies a number of inefficiency sources pertaining to crowding out, bad organs, costs and missed opportunities, family refusals, moral hazard and strength of the provided incentive. However, a complete assessment of futures market requires better knowledge regarding the potential reaction from donors, families and health professionals. (shrink)

Some say that consent is essentially just a state of mind. Others say it is essentially just a communication. Many say it is both. I say it is neither. Instead it is an act, or rather a pair of acts—an internal mental act in the first instance, an external performative act in the second. Each of those acts is an act of commitment, intrapersonally in the first case and interpersonally in the second. The content of the commitment is, familiarly enough, (...) to give permission to someone else to do something that it would be wrong for them to do without your permission. The novelty lies in seeing consent as an act of commitment in those two dimensions and in seeing those as commitments that persist until and unless undone by an act of a similar sort. (shrink)

In this chapter, we provide an overview of the ethical considerations relevant to the use of nudges in organ donation policy. We do not defend a position on the permissibility of nudging in this context, but instead aim to clearly outline the strongest arguments on the different sides of this issue that have been presented in the English-language scholarly bioethics literature. We also highlight the questions that are in need of further investigation. In part 1, we briefly discuss nudging before (...) considering proposals to use nudges to increase the number of registered organ donors, including opt-out donor registration systems and the use of “nudge statements.” In part 2, we discuss the use of nudges to influence the decision-making of family members in circumstances where they have a veto over the donation of their loved one’s organs. (shrink)

This thesis addresses the tension in pragmatic cluster-randomized trials between their social value and the requirement to respect the autonomy of research participants. Pragmatic trials are designed to evaluate the effectiveness of treatments in real-world settings to inform clinical decision-making and promote cost-efficient care. These trials are often embedded into clinical settings and ideally include all patients who would receive the treatments under investigation as a part of routine care. Trialists increasingly adopt cluster-randomized designs—in which intact groups, such as hospitals (...) or clinics, are allocated randomly to study interventions—to simplify the inclusion of all patients. But including all-comers conflicts with the requirement to obtain written informed consent from research participants. Since informed consent is central to respecting patient autonomy, the question arises: how can the ends of autonomy and pragmatism be served simultaneously? Some philosophers argue that patients have an obligation to participate in clinical research and that this may negate consent requirements. I argue that while there may be grounds for a prima facie obligation for patients to participate in clinical research, no compelling argument has demonstrated that the obligation is enforceable. Others assert that broad application of a waiver of consent will facilitate the conduct of pragmatic cluster-randomized trials. I demonstrate that this proposal sharply conflicts with the historical origins of the waiver. I articulate a novel moral foundation for the use of a waiver of consent and show that when trials evaluate treatments delivered directly to patients, the autonomy interests at stake for participants are too substantial to permit its use. My solution draws a distinction between consent requirements in existing policy and consent as an autonomous authorization. As many pragmatic cluster-randomized trials are conducted in primary care settings with no research staff, I argue that patient autonomy can be promoted and protected using clinical-style consent, in which health providers seek verbal informed consent from patients and document it in the electronic health record. This approach has been associated with high rates of recruitment and, thus, may satisfy both requirements for social value and respect for autonomy. (shrink)

This collection features comprehensive overviews of the various ethical challenges in organ transplantation. International readings well-grounded in the latest developments in the life sciences are organized into systematic sections and engage with one another, offering complementary views. All core issues in the global ethical debate are covered: donating and procuring organs, allocating and receiving organs, as well as considering alternatives. Due to its systematic structure, the volume provides an excellent orientation for researchers, students, and practitioners alike to enable a deeper (...) understanding of some of the most controversial issues in modern medicine. (shrink)

“Opt-out” organ procurement policies based on presumed consent are typically advertised as being superior to “opt-in” policies based on explicit consent at securing organs for transplantation. However, Michael Gill has argued that presumed consent policies are also better than opt-in policies at respecting patient autonomy. According to Gill’s Fewer Mistakes Argument, we ought to implement the procurement policy that results in the fewest frustrated wishes regarding organ donation. Given that the majority of Americans wish to donate their organs, it is (...) plausible that a presumed consent policy would result in fewer frustrated wishes compared to the current opt-in policy. It follows that we ought to implement a policy of presumed consent. In this paper, I first consider and find wanting an objection to the Fewer Mistakes Argument developed recently by Douglas MacKay. I also consider an objection put forth by James Taylor but argue that there is a methodological reason to prefer my own argument to Taylor’s. Finally, I argue for two theses: first, that Gill’s major argument in favor of the crucial premise of the Fewer Mistakes Argument is flawed, and second, that the major premise of the Fewer Mistakes Argument is false. (shrink)

In the last ten or fifteen years, realism has emerged as a distinct approach in political theory. Realists are skeptical about the merits of abstract theories of justice. They regard peace, order, and stability as the primary goals of politics. One of the more concrete aims of realists is to develop a realist perspective on legitimacy. I argue that realist accounts of legitimacy are unconvincing, because they do not solve what I call the “puzzle of legitimacy”: the puzzle of how (...) some persons can have the right to rule over others, given that all persons are equals. I focus on the realist accounts of legitimacy developed by Bernard Williams and John Horton. (shrink)

This article explores the meaning and moral significance of presumed consent with particular reference to an opt-out policy for postmortem organ donation. It does so under two general categories: circumstances where we believe consent to have been given and those where we have no reason to believe that it has either been given or been refused. In the context of an opt-out policy, the first category would relate to the idea of tacit consent. It is argued both that substituting the (...) term ‘presumed consent’ would be misleading and that it is unlikely that the conditions for tacit consent would be met in practice. Regarding the second category, where the claim would be one regarding counterfactual consent, two main points are made: that claims about consent are unwarranted, and also that they are unnecessary to moral argument, given that the moral work is done by reasons other than any supposedly provided by a presumption of consent. (shrink)

Where a person is unable to make medical decisions for themselves, law and practice allows others to make decisions on their behalf. This is common at the end of a person’s life where decision-making capacity is often lost. A further, and separate, decision that is often considered at the time of death (and often preceding death) is whether the person wanted to act as an organ or tissue donor. However, in some jurisdictions, the lawful decision-maker for the donation decision (the (...) ‘donation decision-maker’) is different from the person who was granted decision-making authority for medical decisions during the person’s life. To date, little attention has been given in the literature to the ethical concerns and practical problems that arise where this shift in legal authority occurs. Such a change in decision-making authority is particularly problematic where premortem measures are suggested to maximise the chances of a successful organ donation. This paper examines this shift in decision-making authority and discusses the legal, ethical and practical implications of such frameworks. (shrink)

Organ shortage is a major survival issue for millions of people worldwide. Globally 1.2 million people die each year from kidney failure. In this paper, we critically examine and find lacking extant proposals for increasing organ supply, such as opting in and opt out for deceased donor organs, and parochial altruism and paired kidney exchange for live organs. We defend two ethical solutions to the problem of organ shortage. One is to make deceased donor organs automatically available for transplant without (...) requiring consent from the donor or their relatives. The other is for society to buy nonvital organs in a strictly regulated market and provide them to people in need for free. (shrink)

In this reply to Wilkinson and De Wispelaere, I argue that an opt-out donation system can be regarded as tacit consent. I first separate the opt-in/opt-out issue from that of the role that the family ought to play. I then argue that what De Wispelaere calls minimal approval-tracking is not obviously necessary and that, even if it were, opt-out schemes can satisfy this requirement.

This essay is about the timing of research consent, a process that involves participants being given information about, among other things, upcoming research interventions and then being invited to waive their claims against those interventions being undertaken. The standard practice, as regards timing, is as follows: participants are invited to waive all their claims at a single moment in time, and that point in time immediately follows the information-provision. I argue that there we’re not justified in keeping to this practice. (...) What we ought to do is disaggregate the claim-waiving part of the process and move it later, such that the participant is invited to waive her claim against the undertaking of any given intervention only the immediate moment before that intervention is to be undertaken. (shrink)

BackgroundOrgan transplantation represents the most effective and acceptable therapy for end-stage organ failure. However, its frequent practice often leads to a shortage of organs worldwide. To solve this dilemma, some countries, such as Portugal, have switched from an opt-in to an opt-out system, which has raised concerns about respect for individual autonomy. We aimed to evaluate whether young university students are aware of this opt-out system so that they can make informed, autonomous and conscious decisions, as well as to identify (...) the factors that determine a positive attitude toward post-mortem organ donation.MethodsAn observational, cross-sectional study was developed and a questionnaire was administered to first-year students from six faculties of the University of Porto.ResultsOf the 841 participants, 60% were unaware that Portugal had adopted an opt-out system. Among the informed individuals, their main sources of information included social media, internet, and family. Furthermore, only 48% of all participants agreed with the current opt-out system. Female sex (p = 0.049; OR 1.393), knowledge of the law (p < 0.001; OR 4.749) and family being the primary source of information (p < 0.001; OR 2.855) were independent factors associated with a positive attitude toward post-mortem organ donation law.ConclusionsThere is a significant lack of knowledge among young university students regarding the presumed post-mortem organ donation law and how it works. Female sex, having family as a primary source of information and being aware of the presumed post-mortem organ donation law are the strongest independent factors that determine a positive attitude toward the opt-out system. (shrink)

The Organ Donation Act 2019 has introduced an opt-out organ donor register in England, meaning that consent to the donation of organs upon death is presumed unless an objection during life was actively expressed. By assessing the rights of the dead over their organs, the sick to those same organs, and the role of consent in their requisition, this paper interrogates whether such paradigms for deceased organ donation are ethically justifiable. Where legal considerations are applicable, I focus on the recent (...) changes in England as a case in point; however, this paper ultimately challenges the justifiability of opt-out systems in any form, concluding that ethical solutions to organ shortage do not lie in opt-out systems of deceased organ procurement. (shrink)

The last decade has seen significant developments in UK health policy, with are largely claimed to be evidence based. However, such a characterisation ought, in many cases, to be questioned. Policies can be broadly understood as based primarily on either a logical or empirical case. In the absence of relevant empirical evidence, policymakers understandably appeal to logical cases. Once such evidence is available, however, it can inform policy and enable the logical case to be set aside. Such a linear policy (...) process is not always the reality, and logical cases often continue to guide policy decisions in direct opposition to empirical evidence. In this paper, I discuss two recent examples of this disconnect between logical and empirical cases in UK health policy. The first—organ donation—illustrates an example of a significant policy change being made in opposition to the evidence. I refer to this as the improvidence approach. The second—abortion—provides an example of policymakers not making a change that has extensive supporting data. I refer to this using the more recognisable language of the precautionary approach. Ultimately, I argue that both the improvidence and precautionary approaches are examples of problematic public policy where policymakers provide no explicit justification for going against the evidence. (shrink)

All four UK nations have, in recent years, introduced “opt out” organ donation systems. Whilst these systems are largely similar, they operate independently. A key feature of each policy is a residency requirement, stipulating that opt out may only apply where the deceased had been ordinarily resident in that nation for at least 12 months. A resident of Scotland who dies in England, for example, would not fall under opt out. Public awareness is the underlying reasoning for such stipulations. A (...) residency requirement was appropriate when Wales was the only UK nation with an opt out system, but, I suggest, the continued imposition of intra-UK borders on organ donation is unjustified now that all four nations operate the same policy. Further, it has the potential to limit organ donation. There is a need for all four systems to be amended to allow for UK-wide applicability, such that providing the deceased was ordinarily resident in the UK, they can fall under opt out in any of the four nations. I argue that such an amendment is ethically justified – continuing to satisfy the public awareness criterion – and practically straightforward. In doing so, I emphasise that my proposed amendment should extend only to the four UK nations, stopping short of the Crown Dependencies even though they also operate opt out systems for organ donation. (shrink)

BackgroundThis 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.MethodsConceptual, philosophical, and ethical analysis.ResultsI 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.ConclusionsMy 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. (shrink)

Deceased organ donation is widely considered as a case of easy rescue―that is, a case in which A may bestow considerable benefits on B while incurring negligent costs herself. Yet, the policy implications of this observation remain unclear. Drawing on Christopher H. Wellman’s samaritan account of political obligations, the paper develops a case for a so-called opt-out system, i.e., a scheme in which people are defaulted into being donors. The proposal’s key idea is that we may arrange people’s options in (...) specific ways for the sake of others. (shrink)

Altruism and solidarity are concepts that are closely related to organ donation for transplantation. On the one hand, they are typically used for encouraging people to donate. On the other hand, they also underpin the regulations in force in each country to different extents. They are often used indistinctly and equivocally, despite the different ethical implications of each concept. This paper aims to clarify to what extent we can speak of altruism and solidarity in the predominant models of organ donation. (...) It also raises the ethical question of whether these categories are adequate as a basis for such models, bearing in mind that organs are a scarce resource and that a shortage of them may mean that fewer lives are saved or improved. (shrink)

A chief objection to opt-out organ donor registration policies is that they do not secure people's actual consent to donation, and so fail to respect their autonomy rights to decide what happens to their organs after they die. However, scholars have recently offered two powerful responses to this objection. First, Michael B Gill argues that opt-out policies do not fail to respect people's autonomy simply because they do not secure people's actual consent to donation. Second, Ben Saunders argues that opt-out (...) policies do secure people's actual—if not explicit—consent, provided that certain conditions are satisfied. I argue that Gill and Saunders’ arguments are not successful. My conclusion does not imply that jurisdictions should not implement opt-out policies—their failure to secure people's actual consent may be outweighed by other considerations. But, my conclusion does imply that Gill and Saunders are mistaken to claim that opt-out policies are respectful of people's autonomy. (shrink)

This paper looks at the ethics of opt-in vs. opt-out of organ donation as Scotland has transitioned its systems to promote greater organ availability. We first analyse studies that compare the donation rates in other regions due to such a system switch and find that organ increase is inconclusive and modest at best. This is due to a lack of explicit opt-out choices resulting in greater resistance and family override unless there are infrastructures and greater awareness to support such change. (...) The paper then looks at the difference between informed consent of the opt-in vs. presumed consent in the opt-out approaches. Patient autonomy and dignity are better reflected with informed consent. Eighteen months have passed since the new organ donation policy has come into effect, this paper recommends more research into organ donors’ psychological motivations to help governments and the healthcare profession obtain more organs for transplantation. (shrink)

Is there a rational and ethical basis for efforts to rescue individuals in dire straits? When does rescue have ethical support, and when does it reflect an irrational impulse? This paper defines a Rule of Rescue and shows its intuitive appeal. It then proceeds to argue that this rule lacks support from standard principles of justice and from ethical principles more broadly, and should be rejected in many situations. I distinguish between agent-relative and agent-neutral reasons, and argue that the Rule (...) of Rescue qualifies only in a narrow range of cases where agent-relative considerations apply. I conclude that it would be wise to set aside the Rule of Rescue in many cases, especially those involving public policies, where it has only weak normative justification. The broader implications of this analysis are noted. (shrink)

In 2008 the Australian Government introduced a national reform agenda to increase organ and tissue donation. Australia continues to perform poorly by international standards on measures of organ procurement, however. This paper outlines three proposals to improve donation rates and considers the empirical evidence available for each. A number of ethical objections frequently given to resist such proposals are also addressed. Firstly, it is recommended that Australia implement an ‘opt-out’ system of organ donation. Secondly, the existing veto rules should be (...) changed to better protect the wishes of those who wish to donate. Finally, a numer of incentives should be offered to increase donation rates; these could include incentives of financial value, but also non-financial incentives such as prioritisation for the receipt of organs for previous donors. (shrink)

I argue against various versions of the ‘attitude’ view of consent and of the ‘action’ view of consent: I show that neither an attitude nor an action is either necessary or sufficient for consent. I then put forward a different view of consent based on the idea that, given a legitimate epistemic context, absence of dissent is sufficient for consent: what is crucial is having access to dissent. In the latter part of the paper I illustrate my view of consent (...) by applying it to the case of consenting to being an organ donor. (shrink)