Interventions to address antimicrobial resistance: an ethical analysis of key tensions and how they apply in low- income and middle-income countries.

Antimicrobial resistance (AMR) is a global health and one health problem. Efforts to mitigate the problem of AMR are challenging to implement due to unresolved ethical tensions. We present an in-depth ethical analysis of tensions that might hinder efforts to address AMR. First, there is a tension between access and excess in the current population: addressing lack of access requires facilitating use of antimicrobials for some populations, while addressing excessive use for other populations. Second, there is a tension between personal interests and a wider, shared interest in curbing AMR. These personal interests can be viewed from the perspective of individuals seeking care and healthcare providers whose livelihoods depend on using or selling antimicrobials and who profit from the sales and use of antimicrobials. Third, there is a tension between the interests of current populations and the interests of future generations. Last, there is a tension between addressing immediate health threats such as pandemics, and AMR as a 'silent', chronic threat. For each of these tensions, we apply 'descriptive ethics' methods that draw from existing evidence and our experiences living and working in low-income and middle-income countries to highlight how these ethical tensions apply in such settings.

Ethics of early detection of disease risk factors: A scoping review.

BACKGROUND: Scientific and technological advancements in mapping and understanding the interrelated pathways through which biological and environmental exposures affect disease development create new possibilities for detecting disease risk factors. Early detection of such risk factors may help prevent disease onset or moderate the disease course, thereby decreasing associated disease burden, morbidity, and mortality. However, the ethical implications of screening for disease risk factors are unclear and the current literature provides a fragmented and case-by-case picture. METHODS: To identify key ethical considerations arising from the early detection of disease risk factors, we performed a systematic scoping review. The Scopus, Embase, and Philosopher's Index databases were searched for peer-reviewed, academic records, which were included if they were written in English or Dutch and concerned the ethics of (1) early detection of (2) disease risk factors for (3) disease caused by environmental factors or gene-environment interactions. All records were reviewed independently by at least two researchers. RESULTS: After screening 2034 titles and abstracts, and 112 full papers, 55 articles were included in the thematic synthesis of the results. We identified eight common ethical themes: (1) Reliability and uncertainty in early detection, (2) autonomy, (3) privacy, (4) beneficence and non-maleficence, (5) downstream burdens on others, (6) responsibility, (7) justice, and (8) medicalization and conceptual disruption. We identified several gaps in the literature, including a relative scarcity of research on ethical considerations associated with environmental preventive health interventions, a dearth of practical suggestions on how to address expressed concerns about overestimating health capacities, and a lack of insights into preventing undue attribution of health responsibility to individuals. CONCLUSIONS: The ethical concerns arising with the early detection of risk factors are often interrelated and complex. Comprehensive ethical analyses are needed that are better embedded in normative frameworks and also assess and weigh the expected benefits of early risk factor detection. Such research is necessary for developing and implementing responsible and fair preventive health policies.

Antimicrobial stewardship in low- and middle-income countries: Developing a broader perspective through an ethical analysis.

The increase in the number of cases of antimicrobial resistance has gained attention worldwide. The main drivers of this situation are the misuse and overuse of antimicrobials for human and animal health. The imbalance between ensuring appropriate use of antimicrobials and providing equal access in the community makes this an ethical issue. The antimicrobial stewardship programme was initiated in response to this global crisis. Its framework includes interventions targeting the optimisation of antimicrobials in hospitals. Various countries have adopted stewardship interventions, and many success stories have been published. However, the steering of this programme faces hurdles due to the complexity that surrounds decision making in antimicrobial prescription, and the challenges of health systems in lower and middle income countries like India. Addressing these issues will extend the reach of these programmes, increase their sustainability and promote health-related justice to the community.

Ethics of college vaccine mandates, using reasonable comparisons.

In the paper 'COVID-19 vaccine boosters for young adults: a risk-benefit assessment and ethical analysis of mandate policies at universities,' Bardosh et al argued that college mandates of the COVID-19 booster vaccine are unethical. The authors came to this conclusion by performing three different sets of comparisons of benefits versus risks using referenced data and argued that the harm outweighs the risk in all three cases. In this response article, we argue that the authors frame their arguments by comparing values that are not scientifically or reasonably comparable and that the authors used values that represent grossly different risk profiles and grouped them into a set of figures to create an illusion of fair comparisons. We argue that absent the falsely skewed portrayals of a higher level of risk over benefit in their misrepresented figures, the five ethical arguments they presented completely fall apart.

Anti-natalism is incompatible with Theory X.

The anti-natalist philosopher David Benatar defends a position asserting that all life is harmful, and that it is, therefore, wrong to have children. In this paper, I critique Benatar's less-discussed claim that his anti-natalism provides solutions to population ethics problems, such as the Non-Identity Problem, the Repugnant Conclusion, and the Mere Addition Problem, all of which are presented in Derek Parfit's Reasons and Persons. Since the publication of his Better Never to Have Been, Benatar has continued to claim that its provision of such solutions strengthens his defense of anti-natalism. Although Benatar's view has received much criticism, this argument has not been discussed at length. I undertake a thorough examination of the argument and identify reasons to reject it. The central point of my critique is that the implications of Benatar's views in determining ranges of wrong and not-wrong cases of procreation are extensionally inadequate when applied to the problems of population ethics.

Toward a Social Bioethics Through Interpretivism: A Framework for Healthcare Ethics.

Recent global events demonstrate that analytical frameworks to aid professionals in healthcare ethics must consider the pervasive role of social structures in the emergence of bioethical issues. To address this, the authors propose a new sociologically informed approach to healthcare ethics that they term "social bioethics." Their approach is animated by the interpretive social sciences to highlight how social structures operate vis-à-vis the everyday practices and moral reasoning of individuals, a phenomenon known as social discourse. As an exemplar, the authors use social bioethics to reframe common ethical issues in psychiatric services and discuss potential implications. Lastly, the authors discuss how social bioethics illuminates the ways healthcare ethics consultants in both policy and clinical decision-making participate in and shape broader social, political, and economic systems, which then cyclically informs the design and delivery of healthcare.

Translational or translationable? A call for ethno-immersion in (empirical) bioethics research.

The shift towards "empirical bioethics" was largely triggered by a recognition that stakeholders' views and experiences are vital in ethical analysis where one hopes to produce practicable recommendations. Such perspectives can provide a rich resource in bioethics scholarship, perhaps challenging the researcher's perspective. However, overreliance on a picture painted by a group of research participants-or on pre-existing literature in that field-can lead to a biased view of a given context, as the subjectivity of data generated in these ways cannot (and should not wholly) be escaped. In response, we propose the implementation of a complementary approach of ethno-immersion in bioethics research. By positioning oneself in the context being researched, the researcher can better understand the realities of that context. The researcher's understanding will, naturally, be subjective too. However, it will act as a better developed and more informed outsider view, when considering the picture painted by participants and previous studies, thus enabling the researcher to introduce more nuance when analysing data. We introduce this approach after examining what we call the context detachment problem, whereby some bioethics scholarship-empirical or otherwise-fails to reflect the reality of the healthcare setting it concerns. Our proposed ethno-immersion (which differs from formal ethnography) is then explored as a response, highlighting its benefits, and answering the question of timing within a research project. Finally, we reflect on the applicability of our proposal to non-empirical bioethics scholarship, concluding that it remains important but may require some adjustments.

Scientists' Views on the Ethics, Promises and Practices of Synthetic Biology: A Qualitative Study of Australian Scientific Practice.

Synthetic biology is a broad term covering multiple scientific methodologies, technologies, and practices. Pairing biology with engineering, synbio seeks to design and build biological systems, either through improving living cells by adding in new functions, or creating new structures by combining natural and synthetic components. As with all new technologies, synthetic biology raises a number of ethical considerations. In order to understand what these issues might be, and how they relate to those covered in ethics literature on synbio, we conducted an interview study with practicing synthetic biologists affiliated with a synthetic biology centre in Australia. Scientists identified a range of ethical challenges germane to the field, including precarious employment, pressures from industry, gender inequity, and the negative effects of the hyping of synbio. These challenges differed markedly from those identified in the ethics literature, whose treatment of the harms and benefits of synbio remains largely speculative and abstract. In our discussion of the pragmatic, every day ethical issues synthetic biologists face, we illustrate how issues of waste or research integrity play pivotal roles in everything from lived experiences in the laboratory, to long-term research trajectories guiding the field. In a confirmation of the ethical relevance of our participant's views on the field, we argue that the subjects they raise must be included in any ethical analysis of synbio as a field.

HPV Primary and Co-testing: An Ethical Analysis Exploring the Role of Cytology in Cervical Cancer Screening and Management.

With the advancement in our understanding of the causative agents involved with cancer, there has been a considerable amount of debate within the laboratory and cytology community regarding how best to screen for cervical cancer. This paper attempts to review the three different approaches to cervical cancer screening through the lens of the four facie prima principles of biomedical ethics, including the respect for autonomy, principle of beneficence, non-maleficence, and justice. Analyzing the debate on cervical cancer screening platforms through the lens of the four principles of biomedical ethics ensures a comprehensive examination of all facets of the discussion, including a review of not only benefits and harm but also ensures that the final policy is fair and respectful for all the stakeholders. The conclusion from the analysis favors the use of co-testing but also supports making HPV primary and Pap testing viable options, depending on the needs of the community, patients, and providers.

The risk of normative bias in reporting empirical research: lessons learned from prenatal screening studies about the prominence of acknowledged limitations.

Empirical data can be an extremely powerful and influential tool in bioethical research. However, when researchers or policy makers look for answers to ethical questions by engaging with empirical research, there can be a tendency (conscious or unconscious) to shape, report, and use empirical research in a way that confirms their own preferred ethical conclusions. This skewing effect - what we call 'normative bias' - is often so subtle it falls short of clear misconduct and thus can be difficult to call out. However, we argue that this subtle influence of bias has the potential to significantly influence debate and policy around highly sensitive ethical issues and must be guarded against. In this paper we share the lessons we have learned through a journey of self-reflection around the effect that normative bias can have when reporting on and referring to empirical data relating to ethical issues. We use a variety of papers from our area of the ethics of routine prenatal screening to illustrate these subtle but often powerfully distorting effects of bias. Our aim in doing so is not to criticise the work of others, as we recognise our own normative bias, but to improve awareness of this issue, remind the need for reflexivity to guard against our own biases, and introduce a new criterion - the idea of a 'limitation prominence assessment' - that can work as a practical way to evaluate the seriousness of the limitations of an empirical study and thus, the risks of the study being misread or misinterpreted through superficial reading.

How Smart are Smart Materials? A Conceptual and Ethical Analysis of Smart Lifelike Materials for the Design of Regenerative Valve Implants.

It may soon become possible not just to replace, but to re-grow healthy tissues after injury or disease, because of innovations in the field of Regenerative Medicine. One particularly promising innovation is a regenerative valve implant to treat people with heart valve disease. These implants are fabricated from so-called 'smart', 'lifelike' materials. Implanted inside a heart, these implants stimulate re-growth of a healthy, living heart valve. While the technological development advances, the ethical implications of this new technology are still unclear and a clear conceptual understanding of the notions 'smart' and 'lifelike' is currently lacking. In this paper, we explore the conceptual and ethical implications of the development of smart lifelike materials for the design of regenerative implants, by analysing heart valve implants as a showcase. In our conceptual analysis, we show that the materials are considered 'smart' because they can communicate with human tissues, and 'lifelike' because they are structurally similar to these tissues. This shows that regenerative valve implants become intimately integrated in the living tissues of the human body. As such, they manifest the ontological entanglement of body and technology. In our ethical analysis, we argue this is ethically significant in at least two ways: It exacerbates the irreversibility of the implantation procedure, and it might affect the embodied experience of the implant recipient. With our conceptual and ethical analysis, we aim to contribute to responsible development of smart lifelike materials and regenerative implants.

A response to Al et al. Trials 2023;24:233.

In their recent paper, Al and colleagues (Trials 2023;24:233) argue that manipulation of the methods of recruitment using well-known techniques in order to increase enrollment can be ethically acceptable. This brief response challenges that notion as an affront to voluntariness and a devolution of the ethics of human subjects research to the "ethics" of the marketplace.

Defending explicability as a principle for the ethics of artificial intelligence in medicine.

The difficulty of explaining the outputs of artificial intelligence (AI) models and what has led to them is a notorious ethical problem wherever these technologies are applied, including in the medical domain, and one that has no obvious solution. This paper examines the proposal, made by Luciano Floridi and colleagues, to include a new 'principle of explicability' alongside the traditional four principles of bioethics that make up the theory of 'principlism'. It specifically responds to a recent set of criticisms that challenge the supposed need for such a principle to perform an enabling role in relation to the traditional four principles and therefore suggest that these four are sufficient without the addition of explicability. The paper challenges the critics' premise that explicability cannot be an ethical principle like the classic four because it is explicitly subordinate to them. It argues instead that principlism in its original formulation locates the justification for ethical principles in a midlevel position such that they mediate between the most general moral norms and the contextual requirements of medicine. This conception of an ethical principle then provides a mold for an approach to explicability on which it functions as an enabling principle that unifies technical/epistemic demands on AI and the requirements of high-level ethical theories. The paper finishes by anticipating an objection that decision-making by clinicians and AI fall equally, but implausibly, under the principle of explicability's scope, which it rejects on the grounds that human decisions, unlike AI's, can be explained by their social environments.

Values, decision-making and empirical bioethics: a conceptual model for empirically identifying and analyzing value judgements.

It can be assumed that value judgements, which are needed to judge what is 'good' or 'better' and what is 'bad' or 'worse', are involved in every decision-making process. The theoretical understanding and analysis of value judgements is, therefore, important in the context of bioethics, for example, to be able to ethically assess real decision-making processes in biomedical practice and make recommendations for improvements. However, real decision-making processes and the value judgements inherent in them must first be investigated empirically ('empirical bioethics'). For this to succeed, what exactly a 'value judgement' is and of what components it might consist must initially be theoretically clarified. A corresponding conceptual model can then support or even enable empirical data collection and analysis and, above all, subsequent ethical analysis and evaluation. This paper, therefore, presents a value judgement model with its theoretical derivation. It also illustrates its application in an interview study of decision-making between animal experimentation and alternative methods in the context of biomedical research. Though the model itself can be theoretically deepened and extended, the application of the model works in general and helps to uncover what value judgements can enter into decision-making. However, the empirical methods, for example, qualitative interviews, can also be better oriented towards eliciting value judgements (as understood according to the model). Further applications of the model to other topics or by means of other empirical methods are conceivable.

Rules, practices and principles: Putting bioethical principles in their place.

Bioethics seems preoccupied with establishing, debating, promoting and sometimes debunking principles. While these tasks trade on the status of the word 'principle' in our ordinary language, scant attention is paid to the way principles operate in language. In this paper, we explore how principles relate to rules and practices so as to better understand their logic. We argue that principles gain their sense and power from the practices which give them sense. While general principles can be, and are, establishable in abstraction from specific practices, as they are in principlist bioethics, such principles are impotent as moral guides to action. We show that the purchase any principle has as a moral guide to action emerges from its indexical properties as a principle which has sense in a specific practice. The meaning of any principle is internal to the practice and context in which it is invoked and, therefore, principles are not kinds of master rule which dictate moral judgement in new contexts but rather chameleon-like rules which change with the contexture in which they are invoked.

Ethics information retrieval in HTA: state of current practice.

OBJECTIVES: Though there have been longstanding discussions on the value of ethics in health technology assessment (HTA), less awareness exists on ethics information retrieval methods. This study aimed to scope available evidence and determine current practices for ethics information retrieval in HTA. METHODS: Literature searches were conducted in Ovid MEDLINE, LISTA, Scopus, and Google Scholar. Once a list of relevant articles was determined, citation tracking was conducted via Scopus. HTA agency websites were searched for published guidance on ethics searching, and for reports which included ethical analyses. Methods sections of each report were analyzed to determine the databases, subject headings, and keywords used in search strategies. The team also reached out to information specialists for insight into current search practices. RESULTS: Findings from this study indicate that there is still little published guidance from HTA agencies, few HTAs that contain substantial ethical analysis, and even less information on the methodology for ethics information retrieval. The researchers identified twenty-five relevant HTAs. Ten of these reports did not utilize subject-specific databases outside health sciences. Eight reports published ethics searches, with significant overlap in subject headings and text words. CONCLUSIONS: This scoping study of current practice in HTA ethics information retrieval highlights findings of previous studies-while ethics analysis plays a crucial role in HTA, methods for literature searching remain relatively unclear. These findings provide insight into the current state of ethics searching, and will inform continued work on filter development, database selection, and grey literature searching.