Translational bioethics: Reflections on what it can be and how it should work.

Translational ethics (TE) has been developed into a specific approach, which revolves around the argument that strategies for bridging the theory-practice gap in bioethics must themselves be justified on ethical terms. This version of TE incorporates normative, empirical and foundational ethics research and continues to develop through application and in the face of new ethical challenges. Here, I explore the idea that the academic field of bioethics has not yet sufficiently analysed its own philosophical foundation for how it can, and should, be practically relevant; neither has it comprehensively discussed the limitations on what impacts bioethicists should pursue. As a result, there has not been adequate training on how to suitably and appropriately impact real-world practices. Moreover, bioethical perspectives are often competing with other strong interests, for example, economic and political, which may weaken their impact on policy-making. The TE approach I propose can not only facilitate practical impacts of academic bioethics by being better informed by real-world ethical issues but it also supports targeted and ethical justifications of the actual impact of academic work in real-world contexts. In this paper, I clarify the premises for this TE approach, identify further challenges and sketch out potential solutions for the implementation of this methodological framework.

On the Anatomy of Health-related Actions for Which People Could Reasonably be Held Responsible: A Framework.

Should we let personal responsibility for health-related behavior influence the allocation of healthcare resources? In this paper, we clarify what it means to be responsible for an action. We rely on a crucial conceptual distinction between being responsible and holding someone responsible, and show that even though we might be considered responsible and blameworthy for our health-related actions, there could still be well-justified reasons for not considering it reasonable to hold us responsible by giving us lower priority. We transform these philosophical considerations into analytical use first by assessing the general features of health-related actions and the corresponding healthcare needs. Then, we identify clusters of structural features that even adversely affected people cannot reasonably deny constitute actions for which they should be held responsible. We summarize the results in an analytical framework that can be used by decision-makers when considering personal responsibility for health as a criterion for setting priorities.

Pursuing impact in research: towards an ethical approach.

BACKGROUND: Research proactively and deliberately aims to bring about specific changes to how societies function and individual lives fare. However, in the ever-expanding field of ethical regulations and guidance for researchers, one ethical consideration seems to have passed under the radar: How should researchers act when pursuing actual, societal changes based on their academic work? MAIN TEXT: When researchers engage in the process of bringing about societal impact to tackle local or global challenges important concerns arise: cultural, social and political values and institutions can be put at risk, transformed or even hampered if researchers lack awareness of how their 'acting to impact' influences the social world. With today's strong focus on research impacts, addressing such ethical challenges has become urgent within in all fields of research involved in finding solutions to the challenges societies are facing. Due to the overall goal of doing something good that is often inherent in ethical approaches, boundaries to researchers' impact of something good is neither obvious, nor easy to detect. We suggest that it is time for the field of bioethics to explore normative boundaries for researchers' pursuit of impact and to consider, in detail, the ethical obligations that ought to shape this process, and we provide a four-step framework of fair conditions for such an approach. Our suggested approach within this field can be useful for other fields of research as well. CONCLUSION: With this paper, we draw attention to how the transition from pursuing impact within the Academy to trying to initiate and achieve impact beyond the Academy ought to be configured, and the ethical challenges inherent in this transition. We suggest a stepwise strategy to identify, discuss and constitute consensus-based boundaries to this academic activity. This strategy calls for efforts from a multi-disciplinary team of researchers, advisors from the humanities and social sciences, as well as discussants from funding institutions, ethical committees, politics and the society in general. Such efforts should be able to offer new and useful assistance to researchers, as well as research funding agencies, in choosing ethically acceptable, impact-pursuing projects.

The Future Ethics of Artificial Intelligence in Medicine: Making Sense of Collaborative Models.

This article examines the role of medical doctors, AI designers, and other stakeholders in making applied AI and machine learning ethically acceptable on the general premises of shared decision-making in medicine. Recent policy documents such as the EU strategy on trustworthy AI and the research literature have often suggested that AI could be made ethically acceptable by increased collaboration between developers and other stakeholders. The article articulates and examines four central alternative models of how AI can be designed and applied in patient care, which we call the ordinary evidence model, the ethical design model, the collaborative model, and the public deliberation model. We argue that the collaborative model is the most promising for covering most AI technology, while the public deliberation model is called for when the technology is recognized as fundamentally transforming the conditions for ethical shared decision-making.

Responsibility Considerations and the Design of Health Care Policies: A Survey Study of the Norwegian Population.

The objective of this article is to explore people's attitudes toward responsibility in the allocation of public health care resources. Special attention is paid to conceptualizations of responsibility involving blame and sanctions. A representative sample of the Norwegian population was asked about various responsibility mechanisms that have been proposed in the theoretical literature on health care and personal responsibility, from denial of treatment to a tax on unhealthy consumer goods. Survey experiments were employed to study treatment effects, such as whether fairness considerations affect attitudes about responsibility. We find that, overall, a substantial minority of the respondents find it fair to let the health care system sanction people-in one way or another-for voluntary behaviors that increase the risk of becoming ill. Quite surprisingly, we find that people are more prone to report that they should themselves be held responsible for unhealthy lifestyles than others.

How to achieve trustworthy artificial intelligence for health.

Artificial intelligence holds great promise in terms of beneficial, accurate and effective preventive and curative interventions. At the same time, there is also awareness of potential risks and harm that may be caused by unregulated developments of artificial intelligence. Guiding principles are being developed around the world to foster trustworthy development and application of artificial intelligence systems. These guidelines can support developers and governing authorities when making decisions about the use of artificial intelligence. The High-Level Expert Group on Artificial Intelligence set up by the European Commission launched the report Ethical guidelines for trustworthy artificial intelligence in2019. The report aims to contribute to reflections and the discussion on the ethics of artificial intelligence technologies also beyond the countries of the European Union (EU). In this paper, we use the global health sector as a case and argue that the EU's guidance leaves too much room for local, contextualized discretion for it to foster trustworthy artificial intelligence globally. We point to the urgency of shared globalized efforts to safeguard against the potential harms of artificial intelligence technologies in health care.

L'intelligence artificielle regorge de potentiel en matière d'interventions préventives et curatives précises, efficaces et bénéfiques. Mais par la même occasion, elle présente certains risques et peut s'avérer nocive si son développement n'est pas encadré par des règles. Partout dans le monde, des principes directeurs sont instaurés afin de promouvoir un niveau de fiabilité optimal dans l'évolution et l'application des systèmes basés sur l'intelligence artificielle. Ces principes peuvent aider les développeurs et les autorités gouvernementales à prendre des décisions relatives à l'intelligence artificielle. Le Groupe d'experts de haut niveau sur l'intelligence artificielle créé par la Commission européenne a récemment publié un rapport intitulé Lignes directrices en matière d'éthique pour une IA digne de confiance. Objectif de ce rapport : contribuer aux réflexions et discussions portant sur l'éthique des technologies fondées sur l'intelligence artificielle, y compris dans les pays n'appartenant pas à l'Union européenne (UE). Dans ce document, nous utilisons le secteur mondial de la santé comme exemple et estimons que les directives de l'UE accordent un pouvoir discrétionnaire trop important aux autorités locales et au contexte pour véritablement encourager la fiabilité de l'intelligence artificielle dans le monde. Nous insistons également sur l'urgence de mettre en place une protection globale commune contre les éventuels préjudices liés aux technologies d'intelligence artificielle dans le domaine des soins de santé.

La inteligencia artificial es muy prometedora en términos de intervenciones preventivas y curativas beneficiosas, precisas y eficaces. Al mismo tiempo, también hay conciencia de los posibles riesgos y daños que pueden causar los desarrollos no regulados de la inteligencia artificial. Se están elaborando principios fundamentales en todo el mundo para fomentar el desarrollo y la aplicación confiables de los sistemas de inteligencia artificial. Estas directrices pueden servir de apoyo a los desarrolladores y a las autoridades gobernantes en la toma de decisiones sobre el uso de la inteligencia artificial. El Grupo de Expertos de Alto Nivel sobre Inteligencia Artificial establecido por la Comisión Europea ha publicado recientemente el informe Ethical guidelines for trustworthy artificial intelligence (Directrices éticas para una inteligencia artificial confiable). El informe tiene por objeto contribuir a la reflexión y el debate sobre la ética de las tecnologías de inteligencia artificial incluso más allá de los países de la Unión Europea (UE). En este documento, se recurre al sector sanitario mundial como caso de referencia y se argumenta que las directrices de la UE conceden demasiado margen a la discreción local y contextualizada como para fomentar una inteligencia artificial confiable a nivel mundial. Se destaca la urgencia de compartir los esfuerzos internacionales para protegerse de los posibles daños de las tecnologías de inteligencia artificial en la atención sanitaria.

How to reach trustworthy decisions for caesarean sections on maternal request: a call for beneficial power.

Caesarean delivery is a common and life-saving intervention. However, it involves an overall increased risk for short-term and long-term complications for both mother and child compared with vaginal delivery. From a medical point of view, healthcare professionals should, therefore, not recommend caesarean sections without any anticipated medical benefit. Consequently, caesarean sections requested by women for maternal reasons can cause conflict between professional recommendations and maternal autonomy. How can we assure ethically justified decisions in the case of caesarean sections on maternal request in healthcare systems that also respect patients' autonomy and aspire for shared decisions? In the maternal-professional relationship, which can be characterised in terms of reciprocal obligations and rights, women may not be entitled to demand a C-section. Nevertheless, women have a right to respect for their deliberative capacity in the decision-making process. How should we deal with a situation of non-agreement between a woman and healthcare professional when the woman requests a caesarean section in the absence of obvious medical indications? In this paper, we illustrate how the maternal-professional relationship is embedded in a nexus of power, trust and risk that reinforces a structural inferiority for women. To accommodate for beneficial use of power, these decision processes need to be trustworthy. We propose a framework, inspired by Lukes' three-dimensional notion of power, which serves to facilitate trust and allows for beneficial power in shared processes of decision-making about the delivery mode for women requesting planned C-sections.

The need for empathetic healthcare systems.

Medicine is not merely a job that requires technical expertise, but a profession concerned with making the best decisions and recommendations with reference to, and in consultation with, the patient. This means that the skill set required for healthcare professionals in order to provide good care is a combination of scientific knowledge, technical aptitude, and affective qualities or virtues such as compassion and empathy.

Maternal reasons for requesting planned cesarean section in Norway: a qualitative study.

BACKGROUND: Pregnant women who request a cesarean section in the absence of obstetric indication have become a highly debated issue in academic as well as popular literature. In order to find adequate, targeted treatment and preventive strategies, we need a better understanding of this phenomenon. The aim of this study is to provide a qualitative exploration of maternal requests for a planned cesarean section in Norway, in the absence of obstetric indications. METHODS: A descriptive qualitative study was conducted consisting of 17 semi-structured, in-depth interviews with women requesting cesarean section and six focus group discussions with 20 caregivers (nine midwives, 11 obstetricians) working at a university hospital in Norway. Data were analyzed with Systematic Text Condensation, a method for thematic cross-case analysis. RESULTS: Fear of birth emerged most commonly as a result of a previous traumatic birth experience that prompted a preference for a planned cesarean to avoid a repetition of the trauma. For some women in our study, postnatal care and the puerperal period were their crucial past experiences, and giving birth by planned cesarean was seen as a way to ensure mental rather than physical capability to care for the expected child after birth. Others were under the impression of being at high risk for an emergency C-section, and requesting a planned one was based on their perceived risk. Such perceptions included having a narrow pelvis, hereditary factors or previous birth outcomes. Some primiparas requested a planned cesarean based on a deep-seated fear since their early teens, accompanied by alienation towards the idea of giving birth. Some obstetricians participating in our study also experienced requests that lacked what they regarded as any well-grounded reason or significant fear. CONCLUSIONS: Behind a maternal request for a planned cesarean section are various rationales and life experiences needing carefully targeted attention and health care. Previous births are an important driver; thus, maternally requested cesareans should be regarded partly as an iatrogenic problem.

Towards theoretically robust evidence on health equity: a systematic approach to contextualising equity-relevant randomised controlled trials.

Reducing inequalities in health and the determinants of health is a widely acknowledged health policy goal, and methods for measuring inequalities and inequities in health are well developed. Yet, the evidence base is weak for how to achieve these goals. There is a lack of high-quality randomised controlled trials (RCTs) reporting impact on the distribution of health and non-health benefits and lack of methodological rigour in how to design, power, measure, analyse and interpret distributional impact in RCTs. Our overarching aim in this paper is to contribute to the emerging effort to improve transparency and coherence in the theoretical and conceptual basis for RCTs on effective interventions to reduce health inequity. We endeavour to achieve this aim by pursuing two more specific objectives. First, we propose an overview of three broader health equity frameworks and clarify their implications for the measurement of health inequality in RCTs. Second, we seek to clarify the relationship between theory and translational challenges that researchers would need to attend to, in order to ensure that equity-relevant RCTs are coherently grounded in theory.

Can clinical ethics committees be legitimate actors in bedside rationing?

BACKGROUND: Rationing and allocation decisions at the clinical level - bedside rationing - entail complex dilemmas that clinicians and managers often find difficult to handle. There is a lack of mechanisms and aids for promoting fair decisions, especially in hard cases. Reports indicate that clinical ethics committees (CECs) sometimes handle cases that involve bedside rationing dilemmas. Can CECs have a legitimate role to play in bedside rationing? MAIN TEXT: Aided by two frameworks for legitimate priority setting, we discuss how CECs can contribute to enhanced epistemic, procedural and political legitimacy in bedside rationing decisions. Drawing on previous work we present brief case vignettes and outline several potential roles that CECs may play, and then discuss whether these might contribute to rationing decisions becoming legitimate. In the process, key prerequisites for such legitimacy are identified. Legitimacy places demands on aspects such as the CEC's deliberation process, the involvement of stakeholders, transparency of process, the opportunity to appeal decisions, and the competence of CEC members. On these conditions, CECs can help strengthen the legitimacy of some of the rationing decisions clinicians and managers have to make. CONCLUSIONS: On specified conditions, CECs can have a well-justified advisory role to play in order to enhance the legitimacy of bedside rationing decisions.

Could information about herd immunity help us achieve herd immunity? Evidence from a population representative survey experiment.

AIMS: Immunisation causes dramatic reductions in morbidity and mortality from infectious diseases; however, resistance to vaccination is nonetheless widespread. An understudied issue - explored here - is whether appeals to collective as opposed to individual benefits of vaccination encourage people to vaccinate. Knowledge of this is important not least with respect to the design of public health campaigns, which often lack information about the collective benefits of vaccination. METHODS: Using a between-subjects experimental survey design, we test whether information about the effects of herd immunity influences people's decision to vaccinate. A representative sample of Norwegians was confronted with a hypothetical scenario in which a new and infectious disease is on its way to Norway. The sample was split in three - a control group and two treatment groups. The one treatment group was provided information about collective benefits of vaccination; the other was provided information about the individual benefits of vaccination. RESULTS: Both treatments positively affect people's decision to vaccinate; however, informing about the collective benefits has an even stronger effect than informing about the individual benefits. CONCLUSIONS: Our results suggest that people's decision about whether to vaccinate and thus contribute to herd immunity is influenced by concern for others. Thus, stressing the collective benefits of vaccination could increase the effectiveness of health campaigns.

Standards of practice in empirical bioethics research: towards a consensus.

BACKGROUND: This paper reports the process and outcome of a consensus finding project, which began with a meeting at the Brocher Foundation in May 2015. The project sought to generate and reach consensus on standards of practice for Empirical Bioethics research. The project involved 16 academics from 5 different European Countries, with a range of disciplinary backgrounds. METHODS: The consensus process used a modified Delphi approach. RESULTS: Consensus was reached on 15 standards of practice, organised into 6 domains of research practice (Aims, Questions, Integration, Conduct of Empirical Work, Conduct of Normative Work; Training & Expertise). CONCLUSIONS: Through articulating these standards we outline a position that encourages responses, and through those responses we will be able to identify points of agreement and contestation that will drive the conversation forward. In that vein, we would encourage researchers, funders and journals to engage with what we have proposed, and respond to us, so that our community of practice of empirical bioethics research can develop and evolve further.

On classifying the field of medical ethics.

In 2014, the editorial board of BMC Medical Ethics came together to devise sections for the journal that would (a) give structure to the journal (b) help ensure that authors' research is matched to the most appropriate editors and (c) help readers to find the research most relevant to them. The editorial board decided to take a practical approach to devising sections that dealt with the challenges of content management. After that, we started thinking more theoretically about how one could go about classifying the field of medical ethics. This editorial elaborates and reflects on the practical approach that we took at the journal, then considers an alternative theoretically derived approach, and reflects on the possibilities, challenges and value of classifying the field more broadly.

Phase-dependent justification: the role of personal responsibility in fair healthcare.

The main aim of this paper is to examine the fairness of different ways of holding people responsible for healthcare-related choices. Our focus is on conceptualisations of responsibility that involve blame and sanctions, and our analytical approach is to provide a systematic discussion based on interrelated and successive health-related, lifestyle choices of an individual. We assess the already established risk-sharing, backward-looking and forward-looking views on responsibility according to a variety of standard objections. In conclusion, all of the proposed views on holding people responsible for their lifestyle choices are subjected to reasonable critiques, although the risk-sharing view fare considerably better than the others overall considered. With our analytical approach, we are able to identify how basic conditions for responsibility ascription alter along a time axis. Repeated relapses with respect to healthcare associated with persistent, unhealthy lifestyle choices, call for distinct attention. In such situations, contextualised reasoning and transparent policy-making, rather than opaque clinical judgements, are required as steps towards fair allocation of healthcare resources.