Artificial intelligence in clinical decision-making: Rethinking personal moral responsibility.

Artificially intelligent systems (AISs) are being created by software developing companies (SDCs) to influence clinical decision-making. Historically, clinicians have led healthcare decision-making, and the introduction of AISs makes SDCs novel actors in the clinical decision-making space. Although these AISs are intended to influence a clinician's decision-making, SDCs have been clear that clinicians are in fact the final decision-makers in clinical care, and that AISs can only inform their decisions. As such, the default position is that clinicians should hold responsibility for the outcomes of the use of AISs. This is not the case when an AIS has influenced a clinician's judgement and their subsequent decision. In this paper, we argue that this is an imbalanced and unjust position, and that careful thought needs to go into how personal moral responsibility for the use of AISs in clinical decision-making should be attributed. This paper employs and examines the difference between prospective and retrospective responsibility and considers foreseeability as key in determining how personal moral responsibility can be justly attributed. This leads us to the view that moral responsibility for the outcomes of using AISs in healthcare ought to be shared by the clinical users and SDCs.

Clinicians and AI use: where is the professional guidance?

With the introduction of artificial intelligence (AI) to healthcare, there is also a need for professional guidance to support its use. New (2022) reports from National Health Service AI Lab & Health Education England focus on healthcare workers' understanding and confidence in AI clinical decision support systems (AI-CDDSs), and are concerned with developing trust in, and the trustworthiness of these systems. While they offer guidance to aid developers and purchasers of such systems, they offer little specific guidance for the clinical users who will be required to use them in patient care.This paper argues that clinical, professional and reputational safety will be risked if this deficit of professional guidance for clinical users of AI-CDDSs is not redressed. We argue it is not enough to develop training for clinical users without first establishing professional guidance regarding the rights and expectations of clinical users.We conclude with a call to action for clinical regulators: to unite to draft guidance for users of AI-CDDS that helps manage clinical, professional and reputational risks. We further suggest that this exercise offers an opportunity to address fundamental issues in the use of AI-CDDSs; regarding, for example, the fair burden of responsibility for outcomes.

Vaccine confidence, public understanding and probity: time for a shift in focus?

Lack of vaccine confidence can contribute to drops in vaccination coverage and subsequent outbreaks of diseases like measles and polio. Low trust in vaccines is attributed to a combination of factors, including lack of understanding, vaccine scares, flawed policies, social media and mistrust of vaccine manufacturers, scientists and decision-makers. The COVID-19 crisis has laid bare societies' vulnerability to new pathogens and the critical role of vaccines (and their acceptability) in containing this and future pandemics. It has also put science at the forefront of the response, with several governments relying on academics to help shape policy and communicate with the public. Against this backdrop, protecting public trust in scientists and scientific output is arguably more important than ever. Yet, conflicts of interest (CoI) in biomedical research remain ubiquitous and harmful, and measures to curb them have had limited success. There is also evidence of bias in industry-sponsored vaccine studies and academics are voicing concerns about the risks of working in a CoI prevalent research area. Here, we set out to challenge established thinking with regard to vaccine confidence, by shifting the gaze from a deficit in public understanding towards probity in research relationships and suggesting an alternative and perhaps complementary strategy for addressing vaccine mistrust. We argue that a concerted effort needs to be made to revisit the norms that undergird contemporary vaccine research, coupled with a willingness of all stakeholders to reimagine those relationships with an emphasis on demonstrating trustworthiness and probity.

Fallacious, misleading and unhelpful: The case for removing 'systematic review' from bioethics nomenclature.

Attempts to conduct systematic reviews of ethical arguments in bioethics are fundamentally misguided. All areas of enquiry need thorough and informative literature reviews, and efforts to bring transparency and systematic methods to bioethics are to be welcomed. Nevertheless, the raw materials of bioethical articles are not suited to methods of systematic review. The eclecticism of philosophy may lead to suspicion of philosophical methods in bioethics. Because bioethics aims to influence medical and scientific practice it is tempting to adopt scientific language and methods. One manifestation is the increasing innovation in, and use of, systematic reviews of ethical arguments in bioethics. Yet bioethics, as a broadly philosophical area of enquiry, is unsuited to systematic review. Bioethical arguments are evaluative, so notions of quality and bias are inapplicable. Bioethical argument is conceptual rather than numerical, and the classification of concepts is itself a process of argument that cannot aspire to neutrality. Any 'systematic review' of ethical arguments in bioethics thus falls short of that name. Furthermore, labels matter. Although the bioethics research community may find that adopting the language and the outward methods of clinical science offers apparent prospects of credibility, policy influence and funding, we argue that such misdirection carries risks and is unlikely to pay dividends in the long term. Bioethical sources are amenable to the review methods of the social sciences, and it is on these methods that specific methods of bioethics literature review should be built.

The moral distress model: An empirically informed guide for moral distress interventions.

AIMS AND OBJECTIVES: To explore moral distress empirically and conceptually, to understand the factors that mitigate and exacerbate moral distress and construct a model that represents how moral distress relates to its constituent parts and related concepts. BACKGROUND: There is ongoing debate about how to understand and respond to moral distress in nursing practice. DESIGN: The overarching design was feminist empirical bioethics in which feminist interpretive phenomenology provided the tools for data collection and analysis, reported following the COREQ guidelines. Using reflexive balancing, the empirical data were combined with feminist theory to produce normative recommendations about how to respond to moral distress. The Moral Distress Model presented in this paper is a culmination of the empirical data and theory. METHODS: Using feminist interpretive phenomenology, critical care nurses in the United Kingdom (n = 21) were interviewed and data analysed. Reflexive Balancing was used to integrate the data with feminist theory to provide normative recommendations about how to understand moral distress. RESULTS: There are five compounding factors that exacerbate/ mitigate nurses' experiences of moral distress: epistemic injustice; the roster lottery; conflict between one's professional and personal responsibilities; ability to advocate and team dynamics. In addition to the causal connection and responses to moral distress, these factors make up the moral distress model which can guide approaches to mitigate moral distress. CONCLUSIONS: The Moral Distress Model is the culmination of these data and theorising formulated into a construct to explain how each element interacts. We propose that this model can be used to inform the design of interventions to address moral distress.

Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines.

Importance: Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use. Objective: To develop international, consensus-based, PRO-specific ethical guidelines for clinical research. Evidence Review: The PRO ethics guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network's guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance. Findings: Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n = 25 participants). The final wording of the PRO ethical guidelines was agreed on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans. Conclusions and Relevance: The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.

REASONS TO REDEFINE MORAL DISTRESS: A FEMINIST EMPIRICAL BIOETHICS ANALYSIS.

There has been increasing debate in recent years about the conceptualization of moral distress. Broadly speaking, two groups of scholars have emerged: those who agree with Jameton's 'narrow definition' that focuses on constraint and those who argue that Jameton's definition is insufficient and needs to be broadened. Using feminist empirical bioethics, we interviewed critical care nurses in the United Kingdom about their experiences and conceptualizations of moral distress. We provide our broader definition of moral distress and examples of data that both challenge and support our conceptualization. We pre-empt and overcome three key challenges that could be levelled at our account and argue that there are good reasons to adopt our broader definition of moral distress when exploring prevalence of, and management strategies for, moral distress.

Dialysis decisions concerning cognitively impaired adults: a scoping literature review.

BACKGROUND: Chronic kidney disease is a significant cause of global deaths. Those who progress to end-stage kidney disease often commence dialysis as a life-extending treatment. For cognitively impaired patients, the decision as to whether they commence dialysis will fall to someone else. This scoping review was conducted to map existing literature pertaining to how decisions about dialysis are and should be made with, for, and on behalf of adult patients who lack decision-making capacity. In doing so, it forms the basis of a larger body of work that is exploring how these decisions ought to be made. METHODS: To identify relevant papers, searches were conducted on Ovid MEDLINE(R), Embase, PsychINFO, The Cochrane Library, and Web of Science. Inclusion criteria were then applied, requiring that papers: report on empirical studies about how decisions about dialysis are made and/or discuss how decisions about dialysis should be made with, for, and on behalf of adult patients who lack decision-making capacity; be published from 1961 onwards; and be published in English. This resulted in 27 papers eligible for inclusion. RESULTS: Of note, the majority of papers originated in the United States. There was wide variation across the included papers. Extracted data were grouped under the following themes: involving various parties (patient involvement, family dominance, and wider communication); objectivity about care options (including difficulties with family detachment); cultural sensitivity; medical versus non-medical factors; managing nonadherent patients; and the role and prevalence of substituted judgement. The literature shows that there is inconsistency in the principles and processes surrounding decisions made about dialysis with, for, and on behalf of adult patients who lack decision-making capacity. CONCLUSIONS: This scoping review demonstrates that there is significant variation in both the practice and theory of dialysis decision making with, for, and on behalf of cognitively impaired adult patients. Complexity arises in considering who should get a say, how influential their say should be in a decision, and what factors are most relevant to the decision. A lack of up-to-date literature exploring this issue is highlighted, with this scoping review providing a useful groundwork from which further research can be undertaken.

Principles for pandemics: COVID-19 and professional ethical guidance in England and Wales.

BACKGROUND: During the arrival of the COVID-19 pandemic, various professional ethical guidance was issued to (and for) health and social care professionals in England and Wales. Guidance can help to inform and support such professionals and their patients, clients and service users, but a plethora of guidance risked information overload, confusion, and inconsistency. METHODS: During the early months of the pandemic, we undertook a rapid review, asking: what are the principles adopted by professional ethical guidance in England and Wales for dealing with COVID-19? We undertook thematic content analysis of the 29 documents that met our inclusion criteria. RESULTS: The 29 documents captured 13 overlapping principles: respect, fairness, minimising harm, reciprocity, proportionality, flexibility, working together, inclusiveness, communication, transparency, reasonableness, responsibility, and accountability. CONCLUSIONS: We intend this attempt to collate and outline the prominent principles to be helpful, particularly, for healthcare practice during the COVID-19 pandemic and, hopefully, for future pandemic planning. We also offer some reflections on the guidance and the principles therein. After describing the principles, we reflect on some of the similarities and differences in the guidance, and the challenges associated not only with the specific guidance reviewed, but also with the nature and import of "professional ethical guidance".

Tangible co-production? Engaging and creating with fathers.

This paper adds to an increasing body of social science literature, which engages with the research practice of "co-production." It aims to make a distinctive contribution by suggesting that what is produced under this process should be given greater attention. Previous literature has focused on the "co" (cooperative) element: debating whether and under what conditions wider participation between academic and non-academic actors can be genuinely emancipatory, and the degree to which more radical research approaches centred on empowering marginalised groups have been usurped through management discourses of participatory governance. Drawing on a case study of a pilot project that developed support resources for new fathers under the auspices of a co-production research design, the paper highlights the dynamics and limitations of the process, but additionally and distinctively suggests an important way in which the success of co-production can be judged that includes practical and tangible outputs beyond academic knowledge and takes objects and materiality seriously as a dimension of co-production in an academic setting.

Conceptualising Surgical Innovation: An Eliminativist Proposal.

Improving surgical interventions is key to improving outcomes. Ensuring the safe and transparent translation of such improvements is essential. Evaluation and governance initiatives, including the IDEAL framework and the Macquarie Surgical Innovation Identification Tool have begun to address this. Yet without a definition of innovation that allows non-surgeons to identify when it is occurring, these initiatives are of limited value. A definition seems elusive, so we undertook a conceptual study of surgical innovation. This indicated common conceptual areas in discussions of (surgical) innovation, that we categorised alliteratively under the themes of "purpose" (about drivers of innovation), "place" (about contexts of innovation), "process" (about differentiating innovation), "product" (about tangible and intangible results of innovation) and "person" (about personal factors and viewpoint). These conceptual areas are used in varying-sometimes contradictory-ways in different discussions. Highlighting these conceptual areas of surgical innovation may be useful in clarifying what should be reported in registries of innovation. However our wider conclusion was that the term "innovation" carries too much conceptual baggage to inform normative inquiry about surgical practice. Instead, we propose elimination of the term "innovation" from serious discourse aimed at evaluation and regulation of surgery. In our view researchers, philosophers and policy-makers should consider what it is about surgical activity that needs attention and develop robust definitions to identify these areas: for our own focus on transparency and safety, this means finding criteria that can objectively identify certain risk profiles during the development of surgery.

What is 'moral distress' in nursing? A feminist empirical bioethics study.

BACKGROUND: The phenomenon of 'moral distress' has continued to be a popular topic for nursing research. However, much of the scholarship has lacked conceptual clarity, and there is debate about what it means to experience moral distress. Moral distress remains an obscure concept to many clinical nurses, especially those outside of North America, and there is a lack of empirical research regarding its impact on nurses in the United Kingdom and its relevance to clinical practice. RESEARCH AIM: To explore the concept of moral distress in nursing both empirically and conceptually. METHODOLOGY: Feminist interpretive phenomenology was used to explore and analyse the experiences of critical care nurses at two acute care trauma hospitals in the United Kingdom. Empirical data were analysed using Van Manen's six steps for data analysis. ETHICAL CONSIDERATIONS: The study was approved locally by the university ethics review committee and nationally by the Health Research Authority in the United Kingdom. FINDINGS: The empirical findings suggest that psychological distress can occur in response to a variety of moral events. The moral events identified as causing psychological distress in the participants' narratives were moral tension, moral uncertainty, moral constraint, moral conflict and moral dilemmas. DISCUSSION: We suggest a new definition of moral distress which captures this broader range of moral events as legitimate causes of distress. We also suggest that moral distress can be sub-categroised according to the source of distress, for example, 'moral-uncertainty distress'. We argue that this could aid in the development of interventions which attempt to address and mitigate moral distress. CONCLUSION: The empirical findings support the notion that narrow conceptions of moral distress fail to capture the real-life experiences of this group of critical care nurses. If these experiences resonate with other nurses and healthcare professionals, then it is likely that the definition needs to be broadened to recognise these experiences as 'moral distress'.

Mapping, framing, shaping: a framework for empirical bioethics research projects.

BACKGROUND: There is growing interest in the use and incorporation of empirical data in bioethics research. Much of the recent focus has been on specific "empirical bioethics" methodologies, which attempt to integrate the empirical and the normative. Researchers in the field are, however, beginning to explore broader questions, including around acceptable standards of practice for undertaking such research. The framework: In this article, we further widen the focus to consider the overall shape of an empirical bioethics research project. We outline a framework that identifies three key phases of such research, which are conveyed via a landscaping metaphor of Mapping-Framing-Shaping. First, the researcher maps the field of study, typically by undertaking literature reviews. Second, the researcher frames particular areas of the field of study, exploring these in depth, usually via qualitative research. Finally, the researcher seeks to (re-)shape the terrain by issuing recommendations that draw on the findings from the preceding phases. To qualify as empirical bioethics research, the researcher will utilise a methodology that seeks to bridge these different elements in order to arrive at normative recommendations. We illustrate the framework by citing examples of diverse projects which broadly adopt the three-phase framework. Amongst the strengths of the framework are its flexibility, since (as the examples indicate) it does not prescribe any specific methods or particular bridging methodology. However, the framework might also have its limitations, not least because it appears particularly to capture projects that involve qualitative - as opposed to quantitative - research. CONCLUSIONS: Despite its possible limitations, we offer the Mapping-Framing-Shaping framework in the hope that this will prove useful to those who are seeking to plan and undertake empirical bioethics research projects.

Moral Distress and Austerity: An Avoidable Ethical Challenge in Healthcare.

Austerity, by its very nature, imposes constraints by limiting the options for action available to us because certain courses of action are too costly or insufficiently cost effective. In the context of healthcare, the constraints imposed by austerity come in various forms; ranging from the availability of certain treatments being reduced or withdrawn completely, to reductions in staffing that mean healthcare professionals must ration the time they make available to each patient. As austerity has taken hold, across the United Kingdom and Europe, it is important to consider the wider effects of the constraints that it imposes in healthcare. Within this paper, we focus specifically on one theorised effect-moral distress. We differentiate between avoidable and unavoidable ethical challenges within healthcare and argue that austerity creates additional avoidable ethical problems that exacerbate clinicians' moral distress. We suggest that moral resilience is a suitable response to clinician moral distress caused by unavoidable ethical challenges but additional responses are required to address those that are created due to austerity. We encourage clinicians to engage in critical resilience and activism to address problems created by austerity and we highlight the responsibility of institutions to support healthcare professionals in such challenging times.

What is 'moral distress'? A narrative synthesis of the literature.

AIMS: The aim of this narrative synthesis was to explore the necessary and sufficient conditions required to define moral distress. BACKGROUND: Moral distress is said to occur when one has made a moral judgement but is unable to act upon it. However, problems with this narrow conception have led to multiple redefinitions in the empirical and conceptual literature. As a consequence, much of the research exploring moral distress has lacked conceptual clarity, complicating attempts to study the phenomenon. DESIGN: Systematic literature review and narrative synthesis (November 2015-March 2016). DATA SOURCES: Ovid MEDLINE® In-Process & Other Non-Indexed Citations 1946-Present, PsycINFO® 1967-Present, CINAHL® Plus 1937-Present, EMBASE 1974-24 February 2016, British Nursing Index 1994-Present, Social Care Online, Social Policy and Practice Database (1890-Present), ERIC (EBSCO) 1966-Present and Education Abstracts. REVIEW METHODS: Literature relating to moral distress was systematically retrieved and subjected to relevance assessment. Narrative synthesis was the overarching framework that guided quality assessment, data analysis and synthesis. RESULTS: In all, 152 papers underwent initial data extraction and 34 were chosen for inclusion in the narrative synthesis based on both quality and relevance. Analysis revealed different proposed conditions for the occurrence of moral distress: moral judgement, psychological and physical effects, moral dilemmas, moral uncertainty, external and internal constraints and threats to moral integrity. CONCLUSION: We suggest the combination of (1) the experience of a moral event, (2) the experience of 'psychological distress' and (3) a direct causal relation between (1) and (2) together are necessary and sufficient conditions for moral distress.

Who gets the gametes? An argument for a points system for fertility patients.

This paper argues that the convention of allocating donated gametes on a 'first come, first served' basis should be replaced with an allocation system that takes into account more morally relevant criteria than waiting time. This conclusion was developed using an empirical bioethics methodology, which involved a study of the views of 18 staff members from seven U.K. fertility clinics, and 20 academics, policy-makers, representatives of patient groups, and other relevant professionals, on the allocation of donated sperm and eggs. Against these views, we consider some nuanced ways of including criteria in a points allocation system. We argue that such a system is more ethically robust than 'first come, first served', but we acknowledge that our results suggest that a points system will meet with resistance from those working in the field. We conclude that criteria such as a patient's age, potentially damaging substance use, and parental status should be used to allocate points and determine which patients receive treatment and in what order. These and other factors should be applied according to how they bear on considerations like child welfare, patient welfare, and the effectiveness of the proposed treatment.

Setting standards for empirical bioethics research: a response to Carter and Cribb.

This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and significance of the concept of 'integrating' empirical methods and ethical argument as a standard for research practice within empirical bioethics.