In their target article, “Proposed Principles for International Bioethics Conferencing: Anti-Discriminatory, Global, and Inclusive,” Jecker et al. (2024) highlight the growing international scope o...

Formal clinical trials of pig-to-human organ transplant—known as xenotransplantation—may begin this decade, with the first trials likely to consist of either adult renal transplants or pediatric cardiac transplant patients. Xenotransplantation as a systematic scientific study only reaches back to the latter half of the 20th century, with episodic xenotransplantation events occurring prior to that. As the science of xenotransplantation has progressed in the 20th and 21st centuries, the public's knowledge of the potential therapy has also increased. With this, there have (...) been shifting ethical stances toward xenotransplantation in key areas, such as religious and public viewpoints towards xenotransplantation, animal rights, and public health concerns. This review provides a historical–ethical account of xenotransplantation and details if or how viewpoints have shifted over time. (shrink)

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. (shrink)

In the United States, the field of bioethics has expanded over the last two decades. Several institutions offer graduate-level training at both the masters and doctoral level. However, a lack of published literature on the outcomes of doctoral training in bioethics from the perspective of graduates exists. Researchers conducted an online survey of doctoral students who had finished all doctoral requirements but their dissertation, as well as doctoral graduates, of four US-based institutions to ascertain their perspectives on a number of (...) items regarding their doctoral training and their perception of how that training prepared them for their current role in the workforce. Responses from 34 participants were assessed. Respondents had positive overall views on the utility of a bioethics doctorate and the educational training they received in their respective programs. A number of areas for improvement were identified, including better structured clinical ethics training, greater opportunities for research and publishing, and having the ability to teach during their doctoral program, as well as formal pedagogy training. Greater exposure to clinical ethics consultation during the doctoral program was associated with feeling fully prepared as a clinical ethics consultant. This is the first study to assess the perspectives of bioethics doctoral graduates and ABD students regarding the utility of a bioethics doctorate. Per the perspectives of graduates and ABD students, bioethics doctorates are important and effective to train professional bioethicists. We recommend that a few key changes to these programs’ curricula can further bolster their effectiveness. (shrink)

In public health, the issue of pharmaceutical pricing is a perennial problem. Recent high-profile examples, such as the September 2015 debacle involving Martin Shkreli and Turing Pharmaceuticals, are indicative of larger, systemic difficulties that plague the pharmaceutical industry in regards to drug pricing and the impact it yields on their reputation in the eyes of the public. For public health ethics, the issue of pharmaceutical pricing is rather crucial. Simply, individuals within a population require pharmaceuticals for disease prevention and management. (...) In order to be effective, these pharmaceuticals must be accessibly priced. This analysis will explore the notion of corporate social responsibility in regards to pharmaceutical pricing with an aim of restoring a positive reputation upon the pharmaceutical industry in the public eye. The analysis will utilize the 2005 United Nations Educational, Scientific, and Cultural Organization’s Universal Declaration on Bioethics and Human Rights to establish implications regarding the societal responsibilities of pharmaceutical companies in a global context. To accomplish this, Article 14 of the UDBHR—social responsibility and health—will be articulated in order to advocate a viewpoint of socially responsible capitalism in which pharmaceutical companies continue as profit-making ventures, yet establish moral concern for the welfare of all their stakeholders, including the healthcare consumer. (shrink)

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. (shrink)

Clinical trials of xenotransplantation may begin early in the next decade, with kidneys from genetically modified pigs transplanted into adult humans. If successful, transplanting pig hearts into children with advanced heart failure may be the next step. Typically, clinical trials have a specified end date, and participants are aware of the amount of time they will be in the study. This is not so with XTx. The current ethical consensus is that XTx recipients must consent to lifelong monitoring. While this (...) presents challenges to the right to withdraw in the adult population, additional and unanswered questions also linger in the paediatric population. In paediatric XTx, parents or guardians consent not only to the initial treatment of the child but also to lifelong monitoring, thus making a decision whose consequences will remain present as the child develops the capacity for assent, and finally the capacity for informed consent or refusal. This article presents and evaluates unanswered paediatric ethical questions in regard to the right to withdraw from XTx follow-up in the paediatric population. (shrink)

Each year, many young professionals forego advanced education in the traditional doctoral programs of medicine, law, and philosophy in favor of pursuing a PhD or professional doctorate in bioethics or healthcare ethics that is offered by several major institutes of higher education across the United States. These graduates often leverage their degrees into careers within the broader field of bioethics. As such, they represent a growing percentage of professional bioethicists in both academia and healthcare nationwide. Given the significant role that (...) doctoral bioethics programs play in the training of future professional bioethicists, it is imperative that programs conferring bioethics degrees are attuned to the knowledge and skills students will need as they transition to professional positions, especially where this training substantially differs from more traditional doctoral degree tracks. Yet, even given this need, there is nothing in the professional literature regarding doctoral bioethics graduates’ perspectives or the overall efficacy of a bioethics doctorate as compared to more traditional doctoral degree tracks for future professional bioethicists. This paper then gives the perspective of five recent doctoral bioethics graduates on the utility of a bioethics doctorate and areas where the doctorate prepared or underprepared them in their roles as early-career professional bioethicists. (shrink)

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 disenhancementifit becomes possible to do so and if that pain and suffering cannot be eliminated by other means. Despite not being a morally ideal ‘solution’, itismorally better to prevent unavoidable pain until a viable non-animal alternative becomes available. (shrink)

There is a global consensus of ethicists, politicians, physicians, and international documents that reject any sort of market in human organs. Indeed, this issue has received much attention in the literature in the past few decades, with the majority of commentators placing a high correlation between the sale of organs and financial exploitation. While this argument may be tenable, this analysis seeks to draw out further implications of organ sale, including the idea of moralistic exploitation and the concept that providing (...) a market in a nonmarket good may crowd out certain morals that we should care about. This article will initially discuss the issue of moralistic exploitation, drawing implications from the 2005 UNESCO Declaration on Bioethics and Human Rights and will conclude with applying Michael Sandel’s concept that markets crowd out morals to the issue of organ markets. (shrink)

Due to the state of globalized clinical research, questions have been raised as to what, if any, benefits those who contribute to research should receive. One model for compensating research participants is “benefit sharing,” and the basic premise is that, as a matter of justice, those who contribute to scientific research should share in its benefits. While incorporated into several international documents for over two decades, benefit sharing has only been sparsely implemented. This analysis begins by addressing the concept of (...) benefit sharing, its historical development, and how it has been applied in the context of virus sharing for influenza research. The second portion of this analysis presents recommendations for ensuring benefit sharing. These recommendations are threefold: 1) an emphasis on social pressure, 2) the revision of international documents as means to ensure benefit sharing, and 3) greater collaboration between sponsor IRB and host country IRB. Because clinical research is a globalized industry, a global model will be proposed in the second that focuses on collaboration between the sponsor and host country. This collaboration is vital in order to ensure that proper forms of benefit sharing are accomplished as a matter of justice. (shrink)

The importance of bioethics education as a valuable tool to be responsive to medicine’s complexities is affirmed by graduate medical education accreditation bodies and professional organizations alike. The Accreditation Council for Graduate Medical Education, the body that accredits the majority of medical residency and fellowship programs in the United States, affirms the importance of ethics training for physicians in training. How this is accomplished is largely left to the prerogative of individual programs to manage, as benchmarks or milestones to ascertain (...) this are not firmly in place. However, there is doubt that significant education in bioethics is being accomplished by individual residency programs. This review searched the PubMed database for relevant articles on the scope and objectives of ethics education in US and Canadian family medicine residency programs. (shrink)

The importance of bioethics education as a valuable tool to be responsive to medicine’s complexities is affirmed by graduate medical education accreditation bodies and professional organizations alike. The Accreditation Council for Graduate Medical Education, the body that accredits the majority of medical residency and fellowship programs in the United States, affirms the importance of ethics training for physicians in training. How this is accomplished is largely left to the prerogative of individual programs to manage, as benchmarks or milestones to ascertain (...) this are not firmly in place. However, there is doubt that significant education in bioethics is being accomplished by individual residency programs. This review searched the PubMed database for relevant articles on the scope and objectives of ethics education in US and Canadian family medicine residency programs. (shrink)