Ethics in disaster, mass casualty care, and critical care.

The primary ethical principle guiding general medical practice is autonomy. However, in mass casualty (MASCAL) or disaster scenarios, the principles of beneficence and justice become of foremost concern. Despite multiple reviews, publications, and training courses available to prepare for a MASCAL incident, a minority of physicians and healthcare providers are abreast of these. In this review, we describe several MASCAL scenarios and their associated ethical, moral, and medicolegal quandaries in attempts to curb potential future misadventures.

Is it ethically permissible for GPs to promote non-directed altruistic kidney donation to healthy adults?

Doctors hold coexisting ethical duties to avoid causing deliberate harm to their patients (non-maleficence), to act in patients' best interests (beneficence), to respect patients' right to self-determination (autonomy) and to ensure that costs and benefits are fairly distributed among patients (justice). In the context of non-directed altruistic kidney donations (NDAKD), doctors' duties of autonomy and justice are in tension with those of non-maleficence and beneficence. This article examines these competing duties across three scenarios in which general practitioners (GPs) could promote NDAKD to healthy adults. In the first-when a healthy adult patient prompts the GP to discuss NDAKD-the GP is ethically obligated to counsel the patient about NDAKD to respect their autonomy, yet this does not constitute any form of promotion of NDAKD. In the remaining scenarios, healthy adult patients are unaware of the possibility of NDAKD. In the second, it is ethically permissible for GPs to indirectly raise awareness of NDAKD among healthy adults by displaying recruitment campaign material to non-specified groups of patients in their waiting rooms. In the third, it is ethically impermissible for GPs to directly promote NDAKD to individual healthy adults by raising the possibility of NDAKD with such individuals. The major counterarguments raised against this position are problems with kinds of counselling that fail to reach expected professional standards, rather than problems with the ethical claims made in this article.

The ethical canary: narrow reflective equilibrium as a source of moral justification in healthcare priority-setting.

Healthcare priority-setting institutions have good reason to want to demonstrate that their decisions are morally justified-and those who contribute to and use the health service have good reason to hope for the same. However, finding a moral basis on which to evaluate healthcare priority-setting is difficult. Substantive approaches are vulnerable to reasonable disagreement about the appropriate grounds for allocating resources, while procedural approaches may be indeterminate and insufficient to ensure a just distribution. In this paper, we set out a complementary, coherence-based approach to the evaluation of healthcare priority-setting. Drawing on Rawls, we argue that an institutional priority-setter's claim to moral justification can be assessed, in part, based on the extent to which its many normative commitments are mutually supportive and free from dissonance; that is, on the ability to establish narrow reflective equilibrium across the normative content of a priority-setter's policy and practice. While we do not suggest that the establishment of such equilibrium is sufficient for moral justification, we argue that failure to do so might-like the proverbial canary in the coalmine-act as a generalised warning that something is awry. We offer a theoretical argument in support of this view and briefly outline a practical method for systematically examining coherence across priority-setting policy and practice.

Tsunami-tendenko follows the antiextinction principle, not utilitarianism.

This paper examines the concept of 'tsunami-tendenko,' a guideline suggesting that individuals prioritise their own safety over aiding others during large-scale disasters. Kodama defends tsunami-tendenko against accusations of egoism by arguing that the principle can be justified ethically on consequentialist (or more precisely, utilitarian) grounds. Kodama asserts that attempting to assist others during such disasters heightens the risk of 'tomo-daore,' where both the rescuer and the victim may perish. He claims that having people focus solely on saving themselves can maximise the overall number of lives saved. However, we challenge Kodama's assertion that utilitarianism inherently favours tsunami-tendenko over mutual assistance during disasters. Instead, this paper proposes an alternative ethical foundation for tsunami-tendenko grounded in the 'antiextinction principle,' which prioritises minimising the potential for catastrophic outcomes. When considering the ethics of responding to disaster, it is important to distinguish between maximising the number of lives saved (utilitarianism) and minimising the risk of tomo-daore (antiextinction principle). This distinction may be overlooked if the distribution of probabilities is not considered. We conclude that the antiextinction principle aligns more naturally with tsunami-tendenko, emphasising the avoidance of catastrophic outcomes-a concern not always addressed by utilitarianism. Therefore, tsunami-tendenko should be regarded as a societal guideline aimed at preserving community sustainability by averting total destruction.

Ethical argument for establishing good manufacturing practice for phage therapy in the UK.

Antimicrobial resistance (AMR) poses an increasing threat to patient care and population health and there is a growing need for novel therapies to tackle AMR. Bacteriophage (phage) therapy is a re-emerging antimicrobial strategy with the potential to transform how bacterial infections are treated in patients and populations. Currently, in the UK, phages can be used as unlicensed medicinal products on a 'named-patient' basis. We make an ethical case for why it is crucially important for the UK to invest in Good Manufacturing Practice (GMP) for both ongoing unlicensed and future licensed phage therapy. Access to phages produced to GMP (GMP phages) will ensure effective patient care and better outcomes as well as health systems benefits. The UK also has the potential to become a global leader in the timely and cost-efficient manufacturing and supply of a therapy that meets internationally recognised standards.

Beyond coercion: reframing the influencing other in medically assisted death.

This essay considers how we are to understand the decision to end one's life under medical aid-in-dying (MAID) statutes and the role of influencing others. Bioethical concerns about the potential for abuse in MAID have focused predominantly on the risk of coercion and other forms of undue influence. Most bioethical analyses of relational influences in MAID have been made by opponents of MAID, who argue that MAID is unethical, in part, because it cannot cleanly accommodate relational influences. In contrast, proponents of MAID have downplayed the role of relational influences because they may threaten the pillars of autonomy and voluntariness on which the ethics of MAID rest. Drawing on a case study collected as part of an ethnographic study of MAID in Vermont, we show how relations of care are central to MAID decision-making. Such relations may muddle motives for assisted death, exposing the limits of conventional bioethics thinking on MAID and relational influence. Here, we argue that ethical frameworks for MAID should account for the role of relational influences in decision-making, and acknowledge that relational influences may support, as well as undermine, a decision for MAID. We then outline an evaluative framework for determining whether relational influences are undue that identifies six key domains for consideration: mental competence, authenticity, relationship context, having an adequate range options, financial considerations and irremediability. We conclude by suggesting that social relationships may constitute an important source of value in end-of-life decision-making and not only a liability.

Advance directives for oral feeding in dementia: a response to Shelton and Geppert.

In a recent paper in JME, Shelton and Geppert use an approach by Menzel and Chandler-Cramer to sort out ethical dilemmas about the oral feeding of patients in advanced dementia, ultimately arguing that the usefulness of advance directives about such feeding is highly limited. They misunderstand central aspects of Menzel's and Chandler-Cramer's approach, and in making their larger claim that such directives are much less useful than typically presumed, they fail to account for five important elements in writing good directives for dementia and implementing them properly: (1) Directives should be paired with appointment of trusted agents. (2) Appointed agents' authority can be greatly weakened without advance directives to guide them. (3) Directives' implementation does not require clinically precise assessment of dementia's stage. (4) Palliative support is typically required for withholding of oral feeding to be compassionate. (5) The central purpose of stopping feeding is often not the avoidance of suffering but not prolonging unwanted life.

What does it mean for a clinical AI to be just: conflicts between local fairness and being fit-for-purpose?

There have been repeated calls to ensure that clinical artificial intelligence (AI) is not discriminatory, that is, it provides its intended benefit to all members of society irrespective of the status of any protected characteristics of individuals in whose healthcare the AI might participate. There have also been repeated calls to ensure that any clinical AI is tailored to the local population in which it is being used to ensure that it is fit-for-purpose. Yet, there might be a clash between these two calls since tailoring an AI to a local population might reduce its effectiveness when the AI is used in the care of individuals who have characteristics which are not represented in the local population. Here, I explore the bioethical concept of local fairness as applied to clinical AI. I first introduce the discussion concerning fairness and inequalities in healthcare and how this problem has continued in attempts to develop AI-enhanced healthcare. I then discuss various technical aspects which might affect the implementation of local fairness. Next, I introduce some rule of law considerations into the discussion to contextualise the issue better by drawing key parallels. I then discuss some potential technical solutions which have been proposed to address the issue of local fairness. Finally, I outline which solutions I consider most likely to contribute to a fit-for-purpose and fair AI.

Ethical preparedness in genomic medicine: how NHS clinical scientists navigate ethical issues.

Much has been published about the ethical issues encountered by clinicians in genetics/genomics, but those experienced by clinical laboratory scientists are less well described. Clinical laboratory scientists now frequently face navigating ethical problems in their work, but how they should be best supported to do this is underexplored. This lack of attention is also reflected in the ethics tools available to clinical laboratory scientists such as guidance and deliberative ethics forums, developed primarily to manage issues arising within the clinic.We explore what ethical issues are being experienced by clinical scientists, how they think such issues could be best analysed and managed, and whether their practice might be enhanced by more situated approaches to ethics deliberation and practice such as ethical preparedness. From thematic analysis of cases presented by clinical scientists at a specially convened meeting of the UK Genethics Forum, we derived three main ethical themes: (1) the redistribution of labour and responsibilities resulting from the practice of genomic medicine; (2) the interpretation and certainty of results and (3) the proposal that better standardisation and consistency of ethical approaches (for example, more guidelines and policy) could resolve some of the challenges arising.We argue that although standardisation is important for promoting shared understandings of good (including ethical) practice, supplementary approaches to enhance and sustain ethical preparedness will be important to help clinical scientists and others in the recently expanded genetic/genomic medicine environment foster quality ethical thinking.

Mitochondrial replacement techniques for treating infertility.

Mitochondrial replacement techniques (MRTs) usually aim to prevent the genetic transmission of maternally inherited mitochondrial diseases. Until now, only the UK and Australia have implemented specific legal regulations of MRTs. In both countries, clinical trials on these techniques are only permissible for cases with a high risk of severe mitochondrial disease in the offspring. However, these techniques can also be applied to treat infertility, especially for older women with impaired oocyte quality. In some countries without legal regulation of these techniques, MRTs are already offered for this purpose. Yet, this application of MRTs has received insufficient attention in the bioethical literature so far.In this paper, I examine whether there are ethical reasons to prohibit trials on MRTs in the context of infertility when they are permitted for preventing mitochondrial disease. Allowing MRTs in one context but not the other might be justified either because their application in the context of mitochondrial disease (1) is supported by a more convincing evidence base, (2) has a higher potential benefit or (3) has a lower risk. I compare both applications of MRTs with respect to these three factors. I conclude that there is no convincing reason to prohibit clinical trials on MRTs for infertility when they are permitted in the context of mitochondrial disease.

Cardiology researchers' practices and perceived barriers to open science: an international survey.

OBJECTIVE: Open science is a movement and set of practices to conduct research more transparently. Implementing open science will significantly improve public access and supports equity. It also has the potential to foster innovation and reduce duplication through data and materials sharing. Here, we survey an international group of researchers publishing in cardiovascular journals regarding their perceptions and practices related to open science. METHODS: We identified the top 100 'Cardiology and Cardiovascular Medicine' subject category journals from the SCImago journal ranking platform. This is a publicly available portal that draws from Scopus. We then extracted the corresponding author's name and email from all articles published in these journals between 1 March 2021 and 1 March 2022. Participants were sent a purpose-built survey about open science. The survey contained primarily multiple choice and scale-based questions for which we report count data and percentages. For the few text-based responses we conducted thematic content analysis. RESULTS: 198 participants responded to our survey. Participants had a mean response of 6.8 (N=197, SD=1.8) on a 9-point scale with endpoints, not at all familiar (1) and extremely familiar (9), when indicating how familiar they were with open science. When asked about where they obtained open science training, most participants indicated this was done on the job self-initiated while conducting research (n=103, 52%), or that they had no formal training with respect to open science (n=72, 36%). More than half of the participants indicated they would benefit from practical support from their institution on how to perform open science practices (N=106, 54%). A diversity of barriers to each of the open science practices presented to participants were acknowledged. Participants indicated that funding was the most essential incentive to adopt open science. CONCLUSIONS: It is clear that policy alone will not lead to the effective implementation of open science. This survey serves as a baseline for the cardiovascular research community's open science performance and perception and can be used to inform future interventions and monitoring.

Availability of results of clinical trials registered on EU Clinical Trials Register: cross sectional audit study.

Objective: To identify the availability of results for trials registered on the European Union Clinical Trials Register (EUCTR) compared with other dissemination routes to understand its value as a results repository. Design: Cross sectional audit study. Setting: EUCTR protocols and results sections, data extracted 1-3 December 2020. Population: Random sample of 500 trials registered on EUCTR with a completion date of more than two years from the beginning of searches (ie, 1 December 2018). Main outcome measures: Proportion of trials with results across the examined dissemination routes (EUCTR, ClinicalTrials.gov, ISRCTN registry, and journal publications), and for each dissemination route individually. Prespecified secondary outcomes were number and proportion of unique results, and the timing of results, for each dissemination route. Results: In the sample of 500 trials, availability of results on EUCTR (53.2%, 95% confidence interval 48.8% to 57.6%) was similar to the peer reviewed literature (58.6%, 54.3% to 62.9%) and exceeded the proportion of results available on other registries with matched records. Among the 383 trials with any results, 55 (14.4%, 10.9% to 17.9%) were only available on EUCTR. Also, after the launch of the EUCTR results database, median time to results was fastest on EUCTR (1142 days, 95% confidence interval 812 to 1492), comparable with journal publications (1226 days, 1074 to 1551), and exceeding ClinicalTrials.gov (3321 days, 1653 to undefined). For 117 trials (23.4%, 19.7% to 27.1%), however, results were published elsewhere but not submitted to the EUCTR registry, and no results were located in any dissemination route for 117 trials (23.4%, 19.7% to 27.1). Conclusions: EUCTR should be considered in results searches for systematic reviews and can help researchers and the public to access the results of clinical trials, unavailable elsewhere, in a timely way. Reporting requirements, such as the EU's, can help in avoiding research waste by ensuring results are reported. The registry's true value, however, is unrealised because of inadequate compliance with EU guidelines, and problems with data quality that complicate the routine use of the registry. As the EU transitions to a new registry, continuing to emphasise the importance of EUCTR and the provision of timely and complete data is critical. For the future, EUCTR will still hold important information from the past two decades of clinical research in Europe. With increased efforts from sponsors and regulators, the registry can continue to grow as a source of results of clinical trials, many of which might be unavailable from other dissemination routes.