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BackgroundOutcomes for neonatal intestinal failure (IF) have improved significantly over the past two decades, however, there is no consensus for decision making among UK paediatric subspecialists.ObjectivesThe aim was to describe clinician’s attitudes to decision making in neonatal IF and examine variation between subspecialties.MethodsNeonatologists, paediatric surgeons and gastroenterologists were surveyed electronically. They were asked if they would recommend active or palliative care or allow the parents to decide in several scenarios; or if they considered treatment morally obligatory or impermissible.ResultsOf 147 respondents, 81% of gastroenterologists would recommend active care (34.6% regardless of parental decision) for a term infant with total gut Hirschsprung’s compared with 46% and 33% of surgeons and neonatologists. No gastroenterologist would recommend palliation while 23% of both neonatologists and surgeons would. Similarly, 77% of surgeons and 73% of neonatologists would recommend palliation for a 28-week infant with IF and bilateral parenchymal haemorrhages compared with 27% of gastroenterologists.Prognostic estimates also varied. A term baby with IF was estimated to have a survival of >80% at 5 years by 58% of gastroenterologists compared with 11.5% and 2.7% of surgeons and neonatologists. Only 11.5% of surgeons and 2.6% of neonatologist believed a 26-week preterm with IF would have a 5-year survival >60% compared with 59% of gastroenterologists.ConclusionThere is substantial variation in views about outcomes and management choices both within and between specialties; with gastroenterologists being consistently more positive. This is likely to lead to unjustified variation in counselling and parental choices.

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.

Our article aims to provide a comprehensive portrayal of how seven Asian jurisdictions have sought to address the challenge of genetic discrimination (GD) by presenting an analysis of the relevant legislation, policies, and practices. Based on our findings, policy discussion and action on preventing or mitigating GD have been narrowly framed in terms of employment, insurance, disability, marriage, and family planning. Except for South Korea, none of the jurisdictions we examined has adopted specific legislation to prevent GD. However, for Asia to truly benefit from its recent scientific and technological progress in genomics, we highlight the need for these jurisdictions to engage more proactively with the challenges of GD through a coordinated regulatory and governance mechanism.

This paper draws on a case study of a pilot project that developed support resources for new fathers under the auspices of a co‐production research design. It 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., 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.

Attempts to conduct systematic reviews of ethical arguments in bioethics are fundamentally misguided. All areas of inquiry 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 inquiry, 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.

Systematic reviews (SR) are very well elaborated and established for synthesizing statistical information, for example of clinical studies, for determining whether a clinical intervention is effective. SRs are also becoming more and more popular in bioethics. However, the established approach of conducting and reporting a SR cannot be transferred to corresponding work on ethically sensible questions directly. This is because the object of investigation is not statistical information, but conceptual or normative information, e.g., ethical norms, principles, arguments or conclusions. There is some evidence that the quality of reporting of SRs on ethics literature could be improved in many regards. Although insufficient reporting is not a problem specific to bioethics, as poor study reports are also very common in SRs in e.g. medicine, authors of such SRs have the possibility to follow a reporting guideline – the well-established statement on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). For SRs on ethics literature, the PRISMA Statement can only be partially adopted due to the different type of information searched and analyzed.Thus, an international group of authors with years of experience in conducting and reviewing SRs on ethics literature adapted PRISMA for its application in the field of bioethics (“PRISMA-Ethics”). As methods stemming from qualitative research are often used for analysis and synthesis in SRs on ethics literature, also elements of the ENTREQ Guideline were incorporated in PRISMA-Ethics. The resulting reporting guideline has 22 items and is intended to provide authors of SRs on ethics literature with all information necessary for an adequate reporting of their SRs. It also allows readers, reviewers and journal editors critically evaluating the presented results and conclusions made. In this paper, we explain the rationale and give examples for each item. While we acknowledge heterogeneity on how to conduct a SR on ethics literature, we still maintain that there is a need for general reporting standards for improving transparency, understandability and verifiability of such SRs. We invite authors of SRs on ethics literature to test PRISMA-Ethics and to evaluate its usefulness. We hope for a critical discussion of the guideline and welcome its broad implementation.

We welcome this article from Sisk et al. (2020), which argues that principles of implementation science ought to be incorporated into ethics research. We view this work as closely connected to the ...

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”.

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.

BackgroundChronic 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.MethodsTo 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 madeand/ordiscuss 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.ResultsOf 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.ConclusionsThis 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.

When providing care, nephrologists are subject to various ethical duties.Beyond the Hippocratic notion of doing no harm to their patients, nephrologistsalso have duties to respect their patients’ autonomy and dignity, to meet theirpatients’ care goals in the least invasive way, to act impartially, and, ultimately,to do what is (clinically) beneficial for their patients. Juggling these often conflicting duties can be challenging at the best of times but can prove especially difficult when patients are not fully adherent to treatment. When a patient’s nonadherence begins to cause harm to themselves and/or others, it may be questioned whether discontinuation of care is appropriate. We discuss how nephrologists can meet their ethical duties when faced with nonadherence in patients undergoing haemodialysis, including: episodic extreme agitation, poor renal diet, missed haemodialysis sessions, and emergency presentations brought on by nonadherence. Further, we consider the impact of cognitive impairment and provider-family conflict when making care decisions in a nonadherence context, as well as how the COVID-19 pandemic might affect responses to nonadherence. Suggestions are provided for ethically informed responses, prioritising a patient narrative approach that is attentive to patients' values and preferences, multi-disciplinarity, and the use of behavioural contracts and/ortechnology where appropriate.

IntroductionThe post-2005 rise in clinical trials and clinical research conducted in India was accompanied by frequent reports of unethical practices, leading to a series of regulatory changes. We conducted a systematic scoping review to obtain an overview of empirical research pertaining to the ethics of clinical trials/research in India.MethodsOur search strategy combined terms related to ethics/bioethics, informed consent, clinical trials/research and India, across nine databases, up to November 2019. Peer-reviewed research exploring ethical aspects of clinical trials/research in India with any stakeholder groups was included. We developed an evidence map, undertook a narrative synthesis and identified research gaps. A consultation exercise with stakeholders in India helped contextualise the review and identify additional research priorities.ResultsTitles/Abstracts of 9699 articles were screened, full text of 282 obtained and 80 were included. Research on the ethics of clinical trials/research covered a wide range of topics, often conducted with little to no funding. Studies predominantly examined what lay (patients/public) and professional participants (eg, healthcare staff/students/faculty) know about topics such as research ethics or understand from the information given to obtain their consent for research participation. Easily accessible groups, namely ethics committee members and healthcare students were frequently researched. Research gaps included developing a better understanding of the recruitment-informed consent process, including the doctor-patient interaction, in multiple contexts and exploring issues of equity and justice in clinical trials/research.ConclusionThe review demonstrates that while a wide range of topics have been studied in India, the focus is largely on assessing knowledge levels across different population groups. This is a useful starting point, but fundamental questions remain unanswered about informed consent processes and broader issues of inequity that pervade the clinical trials/research landscape. A priority-setting exercise and appropriate funding mechanisms to support researchers in India would help improve the clinical trials/research ecosystem.

Dear Editor We welcome the letter from Dr Sheah, which raises important points, including that the COVID-19 pandemic is more than just a medical crisis which has exposed 'massive inequalities in wealth, income and power' Dr Sheah also correctly notes that a health service borne from solidarity with the most vulnerable in society 'requires a sense of unity beyond what we have historically displayed' Dr Sheah further observes that 'it is science and not mere ideology , which will give us hope as we face uncertainties around the pandemic' Some ideologies may indeed be problematic, but we would nevertheless emphasize that science alone will not provide the solutions Science itself is a tool that can be used for good or for ill, and how we use science matters as much as the science itself Questions about how we should use it are external to science itself As we noted in a BMJ editorial 1 , the UK government may insist it is 'following the science' but 'this implies that the science alone will tell us what to do Not only does this rhetoric shift the responsibility for difficult decisions on to 'the science', it is also wrong Science may provide evidence on which to base decisions, but our values will determine what we do with that evidence and how we select the evidence to use It is disingenuous and misleading to imply that value-free science leads the way' What we need is close interaction between science and ethics-not the dominance of one The problems we collectively face and the solutions we must collectively craft are not just about science;they require just science

Importance Patient-reported outcomes (PROs) can inform healthcare decisions, regulatory decisions, and healthcare policy, and also can be used for audit/benchmarking and to monitor symptoms and provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use. Objective To develop an international, consensus-based, PRO-specific ethical guidelines for clinical research.Evidence ReviewThe PRO ethics guidelines were developed following the Enhancing 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 May 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 two-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: six relevant candidate items from the systematic review and seventeen 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 twelve 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 by consensus meeting participants with input from six additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts/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 minimising participant risk, burden and harm and protecting participant and researcher welfare.

AimsAuditory Verbal Hallucinations (AVH) are a hallmark of psychosis, but affect many other clinical populations. Patients’ understanding and self-management of AVH may differ between diagnostic groups, change over time, and influence clinical outcomes.We aimed to explore patients’ understanding and self-management of AVH in a young adult clinical population.Method35 participants reporting frequent AVH were purposively sampled from a youth mental health service, to capture experiences across psychosis and non-psychosis diagnoses. Diary and photo-elicitation methodologies were used – participants were asked to complete diaries documenting experiences of AVH, and to take photographs representing these experiences. In-depth, unstructured interviews were held, using participant-produced materials as a topic guide. Conventional content analysis was conducted, deriving results from the data in the form of themes.ResultThree themes emerged: (1)Searching for answers, forming identities – voice-hearers sought to explain their experiences, resulting in the construction of identities for voices, and descriptions of relationships with them. These identities were drawn from participants’ life-stories (e.g., reflecting trauma), and belief-systems (e.g., reflecting supernatural beliefs, or mental illness). Some described this process as active / volitional. Participants described re-defining their own identities in relation to those constructed for AVH (e.g. as diseased, 'chosen', or persecuted), others considered AVH explicitly as aspects of, or changes in, their personality.(2)Coping strategies and goals – patients’ self-management strategies were diverse, reflecting the diverse negative experiences of AVH. Strategies were related to a smaller number of goals, e.g. distraction, soothing overwhelming emotions, 'reality-checking', and retaining agency.(3)Outlook – participants formed an overall outlook reflecting their self-efficacy in managing AVH. Resignation and hopelessness in connection with disabling AVH are contrasted with outlooks of “acceptance” or integration, which were described as positive, ideal, or mature.ConclusionTrans-diagnostic commonalities in understanding and self-management of AVH are highlighted - answer-seeking and identity-formation processes; a diversity of coping strategies and goals; and striving to accept the symptom. Descriptions of “voices-as-self”, and dysfunctional relationships with AVH, could represent specific features of voice-hearing in personality disorder, whereas certain supernatural/paranormal identities and explanations were clearly delusional. However, no aspect of identity-formation was completely unique to psychosis or non-psychosis diagnostic groups. The identity-formation process, coping strategies, and outlooks can be seen as a framework both for individual therapies and further research.

BACKGROUND Ubiquitous, smart technology has the potential to assist humans in numerous ways, including with health and social care. COVID-19 has notably hastened the move to remotely delivering many health services. A variety of stakeholders are involved in the process of developing technology. Where stakeholders are research participants, this poses practical and ethical challenges, particularly if the research is conducted in people’s homes. Researchers must observe prima facie ethical obligations linked to participants’ interests in having their autonomy and privacy respected. OBJECTIVE This study aims to explore the ethical considerations around consent, privacy, anonymization, and data sharing with participants involved in SPHERE (Sensor Platform for Healthcare in a Residential Environment), a project for developing smart technology for monitoring health behaviors at home. Participants’ unique insights from being part of this unusual experiment offer valuable perspectives on how to properly approach informed consent for similar smart home research in the future. METHODS Semistructured qualitative interviews were conducted with 7 households (16 individual participants) recruited from SPHERE. Purposive sampling was used to invite participants from a range of household types and ages. Interviews were conducted in participants’ homes or on-site at the University of Bristol. Interviews were digitally recorded, transcribed verbatim, and analyzed using an inductive thematic approach. RESULTS Four themes were identified—motivation for participating; transparency, understanding, and consent; privacy, anonymity, and data use; and trust in research. Motivations to participate in SPHERE stemmed from an altruistic desire to support research directed toward the public good. Participants were satisfied with the consent process despite reporting some difficulties—recalling and understanding the information received, the timing and amount of information provision, and sometimes finding the information to be abstract. Participants were satisfied that privacy was assured and judged that the goals of the research compensated for threats to privacy. Participants trusted SPHERE. The factors that were relevant to developing and maintaining this trust were the trustworthiness of the research team, the provision of necessary information, participants’ control over their participation, and positive prior experiences of research involvement. CONCLUSIONS This study offers valuable insights into the perspectives of participants in smart home research on important ethical considerations around consent and privacy. The findings may have practical implications for future research regarding the types of information researchers should convey, the extent to which anonymity can be assured, and the long-term duty of care owed to the participants who place trust in researchers not only on the basis of this information but also because of their institutional affiliation. This study highlights important ethical implications. Although autonomy matters, trust appears to matter the most. Therefore, researchers should be alert to the need to foster and maintain trust, particularly as failing to do so might have deleterious effects on future research.

Background Ubiquitous, smart technology has the potential to assist humans in numerous ways, including with health and social care. COVID-19 has notably hastened the move to remotely delivering many health services. A variety of stakeholders are involved in the process of developing technology. Where stakeholders are research participants, this poses practical and ethical challenges, particularly if the research is conducted in people’s homes. Researchers must observe prima facie ethical obligations linked to participants’ interests in having their autonomy and privacy respected. Objective This study aims to explore the ethical considerations around consent, privacy, anonymization, and data sharing with participants involved in SPHERE (Sensor Platform for Healthcare in a Residential Environment), a project for developing smart technology for monitoring health behaviors at home. Participants’ unique insights from being part of this unusual experiment offer valuable perspectives on how to properly approach informed consent for similar smart home research in the future. Methods Semistructured qualitative interviews were conducted with 7 households (16 individual participants) recruited from SPHERE. Purposive sampling was used to invite participants from a range of household types and ages. Interviews were conducted in participants’ homes or on-site at the University of Bristol. Interviews were digitally recorded, transcribed verbatim, and analyzed using an inductive thematic approach. Results Four themes were identified—motivation for participating; transparency, understanding, and consent; privacy, anonymity, and data use; and trust in research. Motivations to participate in SPHERE stemmed from an altruistic desire to support research directed toward the public good. Participants were satisfied with the consent process despite reporting some difficulties—recalling and understanding the information received, the timing and amount of information provision, and sometimes finding the information to be abstract. Participants were satisfied that privacy was assured and judged that the goals of the research compensated for threats to privacy. Participants trusted SPHERE. The factors that were relevant to developing and maintaining this trust were the trustworthiness of the research team, the provision of necessary information, participants’ control over their participation, and positive prior experiences of research involvement. Conclusions This study offers valuable insights into the perspectives of participants in smart home research on important ethical considerations around consent and privacy. The findings may have practical implications for future research regarding the types of information researchers should convey, the extent to which anonymity can be assured, and the long-term duty of care owed to the participants who place trust in researchers not only on the basis of this information but also because of their institutional affiliation. This study highlights important ethical implications. Although autonomy matters, trust appears to matter the most. Therefore, researchers should be alert to the need to foster and maintain trust, particularly as failing to do so might have deleterious effects on future research.

Objective:To explore the phenomenology of auditory verbal hallucinations (AVHs) in a clinical sample of young people who have a ‘non-psychotic’ diagnosis.Methods:Ten participants aged 17–31 years with presentation of emotionally unstable personality disorder or post-traumatic stress disorder and frequent AVHs were recruited and participated in a qualitative study exploring their subjective experience of hearing voices. Photo-elicitation and ethnographic diaries were used to stimulate discussion in an otherwise unstructured walking interview.Results:‘Non-psychotic’ voices comprised auditory qualities such as volume and clarity. Participants commonly personified their voices, viewing them as distinct characters with which they could interact and form relationships. There appeared to be an intimate and unstable relationship between participant and voice, whereby voices changed according to the participants’ mood, insecurities, distress and circumstance. Equally, participants reacted to provocation by the voice, leading to changes in mood and circumstance through emotional and physical disturbances. In contrast to our previous qualitative work in psychosis, voice hearing was not experienced with a sense of imposition or control.Conclusions:This phenomenological research yielded in-depth and novel accounts of ‘non-psychotic’ voices which were intimately linked to emotional experience. In contrast to standard reports of voices in disorders such as schizophrenia, participants described a complex and bi-directional relationship with their voices. Many other features were in common with voice hearing in psychosis. Knowledge of the phenomenology of hallucinations in non-psychotic disorders has the potential to inform future more successful management strategies. This report gives preliminary evidence for future research.

Pandemic carries ethical challenges for surgeons

Whilst debate continues regarding how to define moral distress (MD), one constant has been the belief that healthcare professionals often experience MD during end-of-life (EoL) care. In this chapter, we will discuss the concept of MD in the context of EoL care, drawing on a recent case that has attracted global attention and empirical data drawn from Morley’s doctoral studies exploring MD in nursing. We argue that the empirical data supports a broader understanding of MD and that the occurrence of MD during EoL care can highlight other morally complex issues that warrant further exploration.

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.

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.

Research exploring parents’ experiences of having offspring with autism spectrum disorder (ASD) currently underrepresents fathers. This study aimed to develop an understanding of the experience of fathers, with a view to facilitating improved support. Eight fathers participated in semi-structured interviews exploring their experiences of fathering children with ASD. Fathers described their experiences as a path towards acceptance, with independence and integration for their offspring being key goals. Fathers saw themselves as advocates fighting obstructive services to access appropriate care. The value placed on formal and informal support varied, although the need for personalised support was emphasised. Enabling fathers to see their experiences as a journey, whilst engaging them on the important topics of independence and integration, may improve their experience.

IntroductionWorldwide, 10%–20% of children and adolescents experience mental health conditions. However, most such disorders remain undiagnosed until adolescence or adulthood. Little is known about the factors that influence mental health in children and adolescents, especially in low and middle-income countries (LMIC), where environmental threats, such as poverty and war, may affect optimal neurodevelopment. Cohort studies provide important information on risks and resilience across the life course by enabling tracking of the effects of early life environment on health during childhood and beyond. Large birth cohort studies, including twin cohorts that can be aetiologically informative, have been conducted within high-income countries but are not generalisable to LMIC. There are limited longitudinal birth cohort studies in LMIC.MethodsWe sought to enhance the volume of impactful research in Sri Lanka by establishing a Centre of Excellence for cohort studies. The aim is to establish a register of infant, child and adolescent twins, including mothers pregnant with twins, starting in the districts of Colombo (Western Province) and Vavuniya (Northern Province). We will gain consent from twins or parents for future research projects. This register will provide the platform to investigate the aetiology of mental illness and the impact of challenges to early brain development on future mental health. Using this register, we will be able to conduct research that will (1) expand existing research capacity on child and adolescent mental health and twin methods; (2) further consolidate existing partnerships and (3) establish new collaborations. The initiative is underpinned by three pillars: high-quality research, ethics, and patient and public involvement and engagement (PPIE).Ethics and disseminationEthical approval for this study was obtained from the Ethics Review Committee of Sri Lanka Medical Association and Keele University’s Ethical Review Panel. In addition to journal publications, a range of PPIE activities have been conducted.

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.

BackgroundThe 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 aimTo explore the concept of moral distress in nursing both empirically and conceptually.MethodologyFeminist 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 considerationsThe study was approved locally by the university ethics review committee and nationally by the Health Research Authority in the United Kingdom.FindingsThe 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.DiscussionWe 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.ConclusionThe 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’.

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.

Jake Earl correctly identifies a range of ethical problems arising from medical innovation. The definition of innovation itself is, however, deeply problematic, contested, and contestable, and this is something we have grappled with in our own work on surgical innovation. This commentary explores what progress has been made in defining surgical innovation, considers the challenges that remain and how those challenges impact on Earl’s conclusions. It ends by considering a radical - though we think justifiable - departure from contemporary thinking by proposing the elimination of the term ‘innovation’.