AbstractThe Belmont Report continues to be held in high regard, and most bioethical analyses conducted in recent years have presumed that it affects United States federal regulations. However, the assessments of the report’s creators are sharply divided. Understanding the historic reputation of this monumental report is thus crucial. We first recount the historical context surrounding the creation of this report. Subsequently, we review the process involved in developing ethical guidelines and describe the report’s features. Additionally, we analyze the effect of (...) unfolding events on the subsequent creation of federal regulations, especially on gene therapy clinical trials. Moreover, throughout this paper we evaluate the ethical principles outlined in this report and describe how they overlap with the issue of protecting socially vulnerable groups. Based on the analysis, we conclude that the features of the Belmont Report cannot be considered as having affected the basic sections of the federal regulations for ethical reviews that were made uniform in 1981. Nevertheless, regarding the regulations on gene therapy clinical trials—which were at first expected to be applicable to research involving children—in addition to implementing policies regarding the public review of protocols that passed ethical review, this report’s principles are clearly reflected in the key notes that should have been referred to when the report was created. (shrink)

AbstractWhile the literature on oncofertility decision-making was central to the bioethics debate on social egg freezing when the practice emerged in the late 2000s, there has been little discussion juxtaposing the two forms of egg freezing since. This article offers a new perspective on this debate by comparing empirical qualitative data of two previously conducted studies on medical and social egg freezing. We re-analysed the interview data of the two studies and did a thematic analysis combined with interdisciplinary collaborative auditing (...) for empirical ethics projects. Despite their different contexts, major similarities in women’s decision-making and reasoning were found. We developed two main common themes. Firstly, women felt a clear need to plan for future options. Secondly, they manipulated decision-times by postponing definitive decisions and making micro-decisions. The comparison highlights that the passage of time and the preservation of future choice seems to permeate all aspects of the patient experiences in both studies. As a result of considering real-world lived experiences, we suggest that there are many overlaps in women’s reasoning about egg freezing regardless of why they are making a decision to freeze. These overlaps are morally relevant and thus need to be further integrated into the existing arguments that have been canvassed in the flourishing egg freezing and fertility preservation debates across the field, and in policy and practice globally. (shrink)

AbstractDuring the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and 2021. The (...) pharmaceutical company Johnson and Johnson, the National Institutes of Health in the United States, and a private-public partnership of industry, university, and government partners in Britain all undertook preparations. The United Kingdom’s consortium began their Human Challenge Programme in March of 2021.Beyond documenting each effort, the essay puts these scientific and ethical debates in dialogue with the social, epidemiological, and institutional conditions of the pandemic as well as the commercial, intellectual, and political systems in which medical research and Covid-19 challenge studies operated. It shows how different institutions understood risk, benefit, and social value depending on their specific contexts. Ultimately the example of Covid-19 challenge studies highlights the constructedness of such assessments and reveals the utility of deconstructing them retrospectively so as to better understand the interplay of medical research and research ethics with larger social systems and historical contexts. (shrink)

AbstractWe propose an emerging conceptualization of “intervention hesitancy” to address a broad spectrum of hesitancy to disease prevention interventions among healthcare personnel (HCP) beyond vaccine hesitancy. To demonstrate this concept and its analytical benefits, we used a qualitative case-study methodology, identifying a “spectrum” of disease prevention interventions based on (1) the intervention’s effectiveness, (2) how the intervention is regulated among HCP in the Israeli healthcare system, and (3) uptake among HCP in the Israeli healthcare system. Our cases ultimately contribute to (...) a more nuanced conceptualization of hesitancy that HCP express towards disease prevention interventions. Our case interventions included the seasonal influenza vaccine, the Mantoux test, and the hepatitis B (HBV) vaccine. Influenza and HBV are vaccine-preventable diseases, though their respective vaccines vary significantly in effectiveness and uptake among HCP. The Mantoux test is a tuberculin skin test which provides a prevention benchmark for tuberculosis (TB), a non-vaccine preventable disease. We conducted semi-structured interviews with relevant stakeholders and analyzed them within Israeli and international policy context between 2016 and 2019, a period just prior to the COVID-19 pandemic. We propose the conceptualization of “intervention hesitancy”—beyond “vaccine hesitancy”—as “hesitancy towards a wide range of public health interventions, including but not limited to vaccines”. Results suggested that intervention hesitancy among HCP is rooted in weak trust in their employer, poor employment conditions, as well as mixed institutional guidelines and culture. Conceptualizing intervention hesitancy expands the ability of healthcare systems to understand the root of hesitancy and foster a supportive institutional culture and trust, cognizant of diverse disease prevention interventions beyond vaccination. (shrink)

AbstractHow far can smart machines, or carebots, go in performing the profoundly intimate human work of patient caregivers? How will mechanization alter how we understand the essential features of the human task of caregiving and the role of the caregiver? It is these complex questions, with real world implications, that this article discusses in reviewing “Caregiving, Carebots, and Contagion” by philosopher and bioethicist Michael Brannagan.

AbstractDespite the fact that people usually believe that individual health rights have an intrinsic value, they have, in fact, only extrinsic value. They are context dependent. While in normal conditions the current societies try to guarantee individual health rights, the challenge arises in emergency situations. Ones of them are pandemics including current covid-19 pandemic. Emergency situations challenge individual health rights due to insufficient medical resources and non-random criteria of selection of patients. However, there are some reasons to assume that societal (...) and technological processes in the near future will threaten permanently individual health rights in normal conditions. Such processes include progress in commonly available human enhancement technologies, and progress in robotics and automation. In this paper I show how individual health rights will be challenged in both scenarios including catastrophic events and future technological progress. In both cases, the idea of assisted dying is discussed as possibly the unique healthcare principle available for people whose individual health rights will be limited or canceled due to catastrophes or technological and financial exclusion. The special case of future space missions is also discussed as an example of an extreme environment affecting the way moral norms are viewed in health care ethics. (shrink)

This article argues that extended school closures during the Covid-19 pandemic were a moral catastrophe. It focuses on closures in the United States of America and discusses their effect on the pandemic, their harmful effects on children, and other morally relevant factors. It concludes by discussing how these closures came to pass and suggests that the root cause was structural, not individual: the relevant decision-makers were working in an institutional setting that stacked the deck heavily in favor of extended closures.

The global response to the recent coronavirus pandemic has revealed an ethical crisis in public health. This article analyses key pandemic public health policies in light of widely accepted ethical principles: the need for evidence, the least restrictive/harmful alternative, proportionality, equity, reciprocity, due legal process, and transparency. Many policies would be considered unacceptable according to pre-pandemic norms of public health ethics. There are thus significant opportunities to develop more ethical responses to future pandemics. This paper serves as the introduction to (...) this Special Issue of Monash Bioethics Review and provides background for the other articles in this collection. (shrink)

This paper conducts a cost–benefit analysis of Australia’s Covid-19 lockdown strategy relative to pursuit of a mitigation strategy in March 2020. The estimated additional deaths from a mitigation strategy are 11,500 to 40,000, implying a Cost per Quality Adjusted Life Year saved by locking down of at least 11 times the generally employed figure of $100,000 for health interventions in Australia. The lockdowns do not then seem to have been justified by reference to the standard benchmark. Consideration of the information (...) available to the Australian government in March 2020 yields a similar ratio and therefore the same conclusion that lockdown was not warranted. If Australia experiences a new outbreak, and cannot contain it without resort to a nationwide lockdown, the death toll from adopting a mitigation strategy at this point would be even less than had it done so in March 2020, due to the vaccination campaign, lessons learned since March 2020, and because the period over which the virus would then inflict casualties would now be much less than the period from March 2020. This would favour a mitigation policy even more strongly than in March 2020. This approach of assessing the savings in quality adjusted life years and comparing them to a standard benchmark figure ensures that all quality adjusted life years saved by various health interventions are treated equally, which accords with the ethical principle of equity across people. (shrink)

In May 2021, when the Delta variant of SARS-CoV2 was wreaking havoc in India, the Australian Federal Government banned its citizens and residents who were there from coming back to Australia for 14 days on penalty of fines or imprisonment. These measures were justified on the grounds of protecting the broader Australian public from potentially importing the Delta strain, which officials feared would then seed a local outbreak. Those Australians stranded in India, and their families and communities back home, claimed (...) that they were abandoned by Prime Minister Scott Morrison’s government. This case—along with other barriers used as part of border control measures in the name of public health—raises the following question: is it ever morally permissible for a state to ban its citizens and residents from entering their own country during a pandemic? I conclude that it’s impermissible. I argue that persons have a right of entry that should be understood as a security right. This security right should be non-derogable because it’s a foundational good that is necessary for life-planning purposes. Moreover, it is a right that people should be able to rely upon absolutely, even during pandemics. At the very least, should someone believe that there are rare exceptions to the right of entry on public health grounds, governments have a duty—grounded in the principle of reciprocity—to support those who are temporarily denied entry. In the case of Australians stranded in India, I will argue that the Australian Federal Government failed on all accounts. (shrink)

Australia’s experience of the COVID-19 pandemic has been widely perceived to have been a successful one, based on the relatively few number of lives lost to the virus compared to the rest of the world. There remain, nonetheless, serious ethical challenges at the heart of the Australian response to COVID-19. The broadly positive outcomes of Australia’s pandemic response mask more troubling developments within its political culture, and the costs it has imposed on its society. This article examines two concerns in (...) particular: the normalisation of fear and emergency through the language and policy responses adopted by governments, and the significant diminution of individual freedoms and human rights. (shrink)

BackgroundOver the years, Bulgarian bioethics has been mainly an academic enterprise and fallen short of providing health professionals with skills for ethical decision-making. Clinical ethics support (CES) was piloted by the author through two bottom-up models – METAP (Modular, Ethical, Treatment, Allocation of resources, Process) and MCD (Moral Case Deliberation).AimsThis paper aims to present and analyse developments in the area of clinical ethics and the first experiences in CES in Bulgaria.MethodologyThe project reported here included a review of relevant literature on (...) CES methods and evaluation and a documentary review of data from two CES pilot projects: METAP and MCD.ResultsMost of the 69 METAP ethics meetings reviewed were first time meetings (88,4%); the average duration was 36 min and the average number of participants was four (44,9%). The meetings were organized in response to cases of severely or critically ill patients. The ethical dilemmas included choice of treatment (31,9%) and conflicts with the patient or their relatives (23,2%). Consensus was achieved in 34,8% of the cases. The situation was clarified with the patient (27,5%) and within the team (15,9%). The rights and obligations of both sides were discussed in 7,2% of the cases. The experience of the members of the Bulgarian Association of Bioethics and Clinical Ethics (BABCE) with MCD was also presented to justify the inference about the applicability of the two CES models in a Bulgarian context.ConclusionAmong Eastern European countries Bulgaria has made progress in CES. Both METAP and MCD have been found to be useful methods. (shrink)

Regulation and clinical practices regarding end of human life care differ among the nations and countries. These differences reflect the history of the development of state health systems, different societal values, and different understandings of dignity and what it means to protect or respect dignity. The result is variation in the ethical, legal, and practical approaches to end-of-life issues. The article analyzes the diversity of strategies to strengthen dignity at the end of life of terminally ill patients and to highlight (...) the legal preconditions and limitations for implementing these strategies in independent Lithuania, as a former state of the Soviet Union. It is based on the critical analysis of philosophical literature, legal national and international documents and scientific evidence related to the issue. The author argues that the legal system in Lithuania is not sufficient to ensure the patient’s dignity at the end of life and remains far behind other Western European countries. Legal regulations in Lithuania do not guarantee the right of the patient to express his or her will regarding the future treatment, including the refusal of resuscitation, do not regulate the termination of burdensome, non-viable and meaningless treatment that is undesired by the patient, and limit the accessibility of palliative care with its necessary quality and comfort. (shrink)

This article assesses the role of an important Russian public institution, the Russian Orthodox Church (ROC), in shaping the religious discourse on bioethics in Russia. An important step in this process was the approval of ‘The Basis of the Social Concept of the Russian Orthodox Church’ (2000), one chapter of which is devoted to bioethics. However, certain inadequacies in the creation of this document resulted in the absence of a clear position of the Russian Orthodox Church on some end-of-life issues, (...) reproductive technologies, embryo stem cells, and other topics.Using the example of reproductive dilemmas, the author researches how the ROC clarifies its teaching on issues relating to bioethics. In the 2010s the ROC introduced a new method of taking into account the views of believers and the articulation of the church’s position. This article examines the extensive public discussion of a new document, ‘Ethical issues Associated with In Vitro Fertilization’. (shrink)

Lockdowns in Australia have been strict and lengthy. Policy-makers appear to have given the preservation of quantity of lives strong priority over the preservation of quality of lives. But thought-experiments in population ethics suggest that this is not always the right priority. In this paper, I'll discuss both negative impacts on quantity of lives caused by the lockdowns themselves, including an increase in domestic violence, and negative impacts on quality of lives caused by lockdowns, in order to raise the question (...) of whether we each had reason to choose quantity over quality in our own lives in a way that would justify the lockdowns we had. (shrink)