Pediatric Cardiac Xenotransplantation: Recommendations for the Ethical Design of Clinical Trials.

For children with complex congenital heart problems, cardiac allotransplantation is sometimes the best therapeutic option. However, availability of hearts for pediatric patients is limited, resulting in a long and growing waitlist, and a high mortality rate while waiting. Cardiac xenotransplantation has been proposed as one therapeutic alternative for neonates and infants, either in lieu of allotransplantation or as a bridge until an allograft becomes available. Scientific and clinical developments in xenotransplantation appear likely to permit cardiac xenotransplantation clinical trials in adults in the coming years. The ethical issues around xenotransplantation of the heart and other organs and tissues have recently been examined, but to date, only limited literature is available on the ethical issues that are attendant with pediatric heart xenotransplantation. Here, we summarize the ethical issues, focusing on (1) whether cardiac xenotransplantation should proceed in adults or children first, (2) pediatric recipient selection for initial xenotransplantation trials, (3) special problems regarding informed consent in this context, and (4) related psychosocial and public perception considerations. We conclude with specific recommendations regarding ethically informed design of pediatric heart xenotransplantation trials.

Genetic disenhancement and xenotransplantation: diminishing pigs' capacity to experience suffering through genetic engineering.

One objection to xenotransplantation is that it will require the large-scale breeding, raising and killing of genetically modified pigs. The pigs will need to be raised in designated pathogen-free facilities and undergo a range of medical tests before having their organs removed and being euthanised. As a result, they will have significantly shortened life expectancies, will experience pain and suffering and be subject to a degree of social and environmental deprivation. To minimise the impact of these factors, we propose the following option for consideration-ethically defensible xenotransplantation should entail the use of genetic disenhancement if it becomes possible to do so and if that pain and suffering cannot be eliminated by other means. Despite not being a morally ideal 'solution', it is morally better to prevent unavoidable pain until a viable non-animal alternative becomes available.

Xenograft recipients and the right to withdraw from a clinical trial.

Preclinical xenotransplantation research using genetically engineered pigs has begun to show some promising results and could one day offer a scalable means of addressing organ shortage. While it is a fundamental tenet of ethical human subject research that participants have a right to withdraw from research once enrolled, several scholars have argued that the right to withdraw from xenotransplant research should be suspended because of the public health risks posed by xenozoonotic transmission. Here, we present a comprehensive critical evaluation of the claim that xenotransplant recipients should be required to waive their right to withdraw from lifelong biosurveillance. We conclude that if xenotransplantation requires participants to waive their right to withdraw, then clinical trials may not be justifiable, given the ethical and legal obstacles involved with doing so. Consequently, if clinical trials are permitted with a right to withdraw, then they may pose a significant public health risk.

Animal rights, animal research, and the need to reimagine science.

What would it look like for researchers to take non-human animal rights seriously? Recent discussions foster the impression that scientific practice needs to be reformed to make animal research ethical: just as there is ethically rigorous human research, so there can be ethically rigorous animal research. We argue that practically little existing animal research would be ethical and that ethical animal research is not scalable. Since animal research is integral to the existing scientific paradigm, taking animal rights seriously requires a radical, wholesale reimagining of science.Trial registration: ClinicalTrials.gov identifier: NCT05340426.

Xenotransplantation Clinical Trials and Equitable Patient Selection.

Xenotransplant patient selection recommendations restrict clinical trial participation to seriously ill patients for whom alternative therapies are unavailable or who will likely die while waiting for an allotransplant. Despite a scholarly consensus that this is advisable, we propose to examine this restriction. We offer three lines of criticism: (1) The risk-benefit calculation may well be unfavorable for seriously ill patients and society; (2) the guidelines conflict with criteria for equitable patient selection; and (3) the selection of seriously ill patients may compromise informed consent. We conclude by highlighting how the current guidance reveals a tension between the societal values of justice and beneficence.

Why humans kill animals and why we cannot avoid it.

Killing animals has been a ubiquitous human behaviour throughout history, yet it is becoming increasingly controversial and criticised in some parts of contemporary human society. Here we review 10 primary reasons why humans kill animals, discuss the necessity (or not) of these forms of killing, and describe the global ecological context for human killing of animals. Humans historically and currently kill animals either directly or indirectly for the following reasons: (1) wild harvest or food acquisition, (2) human health and safety, (3) agriculture and aquaculture, (4) urbanisation and industrialisation, (5) invasive, overabundant or nuisance wildlife control, (6) threatened species conservation, (7) recreation, sport or entertainment, (8) mercy or compassion, (9) cultural and religious practice, and (10) research, education and testing. While the necessity of some forms of animal killing is debatable and further depends on individual values, we emphasise that several of these forms of animal killing are a necessary component of our inescapable involvement in a single, functioning, finite, global food web. We conclude that humans (and all other animals) cannot live in a way that does not require animal killing either directly or indirectly, but humans can modify some of these killing behaviours in ways that improve the welfare of animals while they are alive, or to reduce animal suffering whenever they must be killed. We encourage a constructive dialogue that (1) accepts and permits human participation in one enormous global food web dependent on animal killing and (2) focuses on animal welfare and environmental sustainability. Doing so will improve the lives of both wild and domestic animals to a greater extent than efforts to avoid, prohibit or vilify human animal-killing behaviour.

The Impairment Argument and Future-Like-Ours: A Problematic Dependence.

In response to criticism of the impairment argument for the immorality of abortion, Bruce Blackshaw and Perry Hendricks appeal to Don Marquis's future-like-ours (FLO) account of the wrongness of killing to explain why knowingly causing fetal impairments is wrong. I argue that wedding the success of the impairment argument to FLO undermines all claims that the impairment argument for the immorality of abortion is novel. Moreover, I argue that relying on FLO when there are alternative explanations for the wrongness of causing FAS begs the question. I conclude, therefore, that the impairment argument remains unsuccessful.

In defense of xenotransplantation research: Because of, not in spite of, animal welfare concerns.

It is envisioned that one day xenotransplantation will bring about a future where transplantable organs can be safely and efficiently grown in transgenic pigs to help meet the global organ shortage. While recent advances have brought this future closer, worries remain about whether it will be beneficial overall. The unique challenges and risks posed to humans that arise from transplanting across the species barrier, in addition to the costs borne by non-human animals, has led some to question the value of xenotransplantation altogether. In response, we defend the value of xenotransplantation research, because it can satisfy stringent welfare conditions on the permissibility of animal research and use. Along the way, we respond to the alleged concerns, and conclude that they do not currently warrant a cessation or a curtailing of xenotransplantation research.

Compassionate Conservation is indistinguishable from traditional forms of conservation in practice.

Animal welfare and ethics are important factors influencing wildlife conservation practice, and critics are increasingly challenging the underlying ethics and motivations supporting common conservation practices. "Compassionate Conservationists" argue that all conservationists should respect the rights of individual sentient animals and approach conservation problems from a position of compassion, and that doing so requires implementing practices that avoid direct harm to individual animals. In this way Compassionate Conservationists seek to contrast themselves with "Traditional Conservationists" who often express consequentialist decision-making processes that ostensibly aim to dispassionately minimize net animal harms, resulting in the common use of practices that directly harm or kill some animals. Conservationists and other observers might therefore conclude that the two sides of this debate are distinct and/or that their policy proscriptions produce different welfare outcomes for animals. To explore the validity of this conclusion we review the ethical philosophies underpinning two types of Compassionate Conservation-deontology and virtue ethics. Deontology focusses on animal rights or the moral duties or obligations of conservationists, whereas virtue ethics focusses on acting in ways that are virtuous or compassionate. We demonstrate that both types permit the intentional harm and killing of animals when faced with common conservation problems where animals will be harmed no matter what the conservationist does or does not do. We then describe the applied decision-making processes exhibited by Compassionate Conservationists (of both types) and Traditional Conservationists to show that they may each lead to the implementation of similar conservation practices (including lethal control) and produce similar outcomes for animals, despite the perceived differences in their ethical motivations. The widespread presence of wildlife conservation problems that cannot be resolved without causing at least some harm to some animals means that conservationists of all persuasions must routinely make trade-offs between the welfare of some animals over others. Compassionate Conservationists do this from an explicit position of animal rights and/or compassion, whereas Traditional Conservationists respect animal rights and exhibit this same compassion implicitly. These observations lead to the conclusion that Compassionate Conservation is indistinguishable from traditional forms of conservation in practice, and that the apparent disagreement among conservationists primarily concerns the effectiveness of various wildlife management practices at minimizing animal harm, and not the underlying ethics, motivations or morality of those practices.

The virtue of compassion in compassionate conservation.

The role of ethics is becoming an increasingly important feature of biodiversity conservation dialogue and practice. Compassionate conservationists argue for a prohibition of, or at least a strong presumption against, the adoption of conservation policies that intentionally harm animals. They assert that to be compassionate is to care about animals and that it is antithetical to caring for animals to intentionally harm them. Compassionate conservationists thus criticize many existing conservation practices and policies. Two things together challenge the philosophical foundation of compassionate conservation. First, compassionate conservationists ground their theory in virtue ethics, yet virtue ethics permits exceptions to moral rules, so there cannot be an in-principle prohibition on adopting intentional harm-inducing policies and practices. But not all compassionate conservationists advocate for a prohibition on intentionally harming animals, only a strong presumption against it. This leads to the second point: compassion can motivate a person to adopt a harm-inducing conservation policy or practice when doing so is the best available option in a situation in which animals will be harmed no matter what policy or practice is adopted. Combining these insights with the empirical observation that conservationists regularly find themselves in tragic situations, we arrive at the conclusion that conservationists may regularly advocate for harm-inducing policies and practices from a position of compassion. Article Impact Statement: Compassionate conservationists should accept that the virtuously compassionate person may adopt harm-causing conservation policies.

La Virtud de la Compasión en la Conservación Compasiva Resumen El papel de la ética es una función cada vez más importante para el diálogo y la práctica de la conservación. Los conservacionistas compasivos alegan a favor de la prohibición, o al menos una presunción legal robusta en contra, de la adopción de políticas de conservación que dañan intencionalmente a los animales. Los conservacionistas compasivos afirman que ser compasivo es cuidar a los animales y que es contrario a esto el querer dañarlos intencionalmente. Por lo tanto, estos conservacionistas critican muchas prácticas y políticas de conservación existentes. Hay dos cosas que en conjunto cuestionan el fundamento filosófico de la conservación compasiva. La primera es que los conservacionistas compasivos basan su teoría en la ética de las virtudes, pero esta ética permite excepciones a las reglas morales, por lo que no puede haber una prohibición en principio de la adopción de políticas y prácticas que dañan intencionalmente a los animales. Pero no todos los conservacionistas compasivos abogan por la prohibición del daño intencional a los animales, sino que abogan sólo por una presunción legal robusta en su contra. Esto nos lleva al segundo punto: la compasión puede motivar a una persona a adoptar políticas o prácticas de conservación que causen daño intencional cuando esto es la mejor opción disponible en una situación en la que los animales serán dañados sin importar cuál práctica o política se adopte. Con la combinación de estas percepciones y la observación empírica de que los conservacionistas regularmente se encuentran a sí mismos en situaciones trágicas, llegamos a la conclusión de que los conservacionistas pueden abogar con frecuencia por políticas y prácticas que inducen daños desde una posición compasiva.

Why appeals to the moral significance of birth are saddled with a dilemma.

In 'Dilemma for Appeals to the Moral Significance of Birth', we argued that a dilemma is faced by those who believe that birth is the event at which infanticide is ruled out. Those who reject the moral permissibility of infanticide by appeal to the moral significance of birth must either accept the moral permissibility of a late-term abortion for a non-therapeutic reason or not. If they accept it, they need to account for the strong intuition that her decision is wrong as well as deny the underlying normative principle that killing a viable fetus requires good reason, and not wanting to care for the child when the child could be easily placed for adoption is not a good enough reason to abort. If they reject the moral permissibility of the late-term abortion, they need to explain why her decision is wrong. Doing so, however, will undermine their own project of denying infanticide by appeal to birth. Walter Veit argues that the dilemma relies too much on intuition and does not live up to biological continuity. We explain why his criticisms are unconvincing.

A critical examination of the false hope harms argument.

Marleen Eijkholt presents a new argument in healthcare ethics, the false hope harms (FHH) argument. In brief, false hope promotes a host of individual harms (e.g., financial, physical, and psychological harms) and system-level harms (e.g., distrust of medical practitioners, increased complexity of care and the associated costs), all of which provide reason for healthcare providers to stop promoting false hope in medicine. The goal of this paper is to show that the FHH argument is unsuccessful.

Dilemma for appeals to the moral significance of birth.

Giubilini and Minerva argue that the permissibility of abortion entails the permissibility of infanticide. Proponents of what we refer to as the Birth Strategy claim that there is a morally significant difference brought about at birth that accounts for our strong intuition that killing newborns is morally impermissible. We argue that strategy does not account for the moral intuition that late-term, non-therapeutic abortions are morally impermissible. Advocates of the Birth Strategy must either judge non-therapeutic abortions as impermissible in the later stages of pregnancy or conclude that they are permissible on the basis of premises that are far less intuitively plausible than the opposite conclusion and its supporting premises.

Orphans and the relational significance of birth: a response to Singh.

Prabhpal Singh has defended a relational account of the difference in moral status between fetuses and newborns. Newborns stand in the parent-child relation while fetuses do not, and standing in the parent-child relationship brings with it higher moral status for newborns. Orphans pose a problem for this account because they do not stand in a parent-child relationship. I argue that Singh has not satisfactorily responded to the problem.