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A recent study published in Human Reproduction investigated the feasibility of testicular tissue re-implantation as a method to restore fertility in infertile adult males. The study found that while the transplanted tissue was able to survive, it did not generate sperm, raising questions about the suitability of this approach for certain patients. The study also emphasized the importance of publishing negative results to inform future clinical applications. The authors discussed the ethical considerations of "first in human" procedures and the benefits of publishing negative results. They concluded that re-implantation of testicular tissue may be more beneficial for prepubertal boys facing gonadotoxic therapies, as their testicular tissue is healthier and more likely to generate functional sperm. [Extracted from the article]

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. [ABSTRACT FROM AUTHOR]

The article focuses on the concept of translational bioethics, exploring its definition, purpose, and need within the field of bioethics. Topics discussed include the challenges of influencing policy, the translation of ethical theories into practical models, and the interface between translational bioethics and medical education, aiming to advance discourse in this area.

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. [ABSTRACT FROM AUTHOR]

Background: Withdrawal of treatment is a common practice in intensive care units when treatment is considered futile. Compassion is an important aspect of care; however, it has not been explored much within the context of treatment withdrawal in intensive care units. Objectives: The aim was to examine how concepts of compassion are framed, utilised and communicated by intensive care nurses in the context of treatment withdrawal. Design: The study employed a qualitative approach conducting secondary analysis of an original data set. In the primary study, 13 nurses were recruited from three intensive care units within a large hospital in United Kingdom. Deductive framework analysis was used to analyse the data in relation to compassionate care. Ethical considerations: The primary study was approved by the local Research Ethics Committee and the hospital's Research and Development services. Findings: Compassionate care was mostly directed to the patient's family and was demonstrated through care and emotional support to the family. It was predominantly expressed through attempts to maintain the patient's dignity by controlling symptoms, maintaining patient cleanliness and removing technical apparatus. Conclusion: This study's findings provide insight about compassionate care during treatment withdrawal which could help to understand and develop further clinicians' roles. Prioritising the family over the patient raised concerns among nurses, who motivated by compassion, may feel justified in taking measures that are in the interests of the family rather than the patient. Further work is needed to explore the ethics of this. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The article focuses on the principles of implementation science ought to be incorporated into ethics research. Topic include the challenge has been to explore methodologies that integrate empirical and ethical analysis, in a way that "respects the sound empirical point that facts and values are not distinct in practice, but that also does not fall foul of the is/ ought problem as defined in philosophical terms" (Ives and Draper, 2009, 254).

The article examines an article by B. Sisk et al. which asserts the need to incorporate the principle of implementation science into ethics research considering lessons from empirical bioethics research coming out of Europe. It cites concerns over the lack of engagement with the issue, including indication of a myopic engagement with bioethics outside the U.S. and casting the philosophical bioethicist as the decision-maker.

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Conditional and directed deceased organ donations occur when donors (or often their next of kin) attempt to influence the allocation of their donated organs. This can include asking that the organs are given to or withheld from certain types of people, or that they are given to specified individuals. Donations of these types have raised ethical concerns, and have been prohibited in many countries, including the UK. In this article we report the findings from a qualitative study involving interviews with potential donors (n = 20), potential recipients (n = 9) and transplant staff (n = 11), and use these results as a springboard for further ethical commentary. We argue that although participants favoured unconditional donation, this preference was grounded in a false distinction between 'medical' and 'non-medical' allocation criteria. Although there are good reasons to maintain organ allocation based primarily upon the existing 'medical' criteria, it may be premature to reject all other potential criteria as being unacceptable. Part of participants' justification for allocating organs using 'medical' criteria was to make the best use of available organs and avoid wasting their potential benefit, but this can also justify accepting conditional donations in some circumstances. We draw a distinction between two types of waste - absolute and relative - and argue that accepting conditional donations may offer a balance between these forms of waste. [ABSTRACT FROM AUTHOR]

Background: Assessment of patient-reported outcomes (PROs) provides valuable information to inform patient-centered care, but may also reveal ‘PRO alerts’: psychological distress or physical symptoms that may require an immediate response. Ad-hoc management of PRO alerts in clinical trials may result in suboptimal patient care or potentially bias trial results. To gain greater understanding of current practice in PRO alert management we conducted a national survey of personnel involved in clinical trials with a PRO endpoint. Methods and Findings: We conducted a national cross-sectional survey of 767 UK-based research nurses, data managers/coordinators, trial managers and chief/principal investigators involved in clinical trials using PROs. Respondents were self-selected volunteers from a non-randomised sample of eligible individuals recruited via 55 UK Clinical Research Collaboration Registered Clinical Trials Units and 19 Comprehensive Local Research Networks. Questions centred on the proportion of trial personnel encountering alerts, how staff responded to PRO alerts and whether current guidance was deemed sufficient to support research personnel. We undertook descriptive analyses of the quantitative data and directed thematic analysis of free-text comments. 20% of research nurses did not view completed PRO questionnaires and were not in a position to discover alerts, 39–50% of the remaining respondent group participants reported encountering PRO alerts. Of these, 83% of research nurses and 54% of data managers/trial coordinators reported taking action to assist the trial participant, but less than half were able to record the intervention in the trial documentation. Research personnel reported current PRO alert guidance/training was insufficient. Conclusions: Research personnel are intermittently exposed to PRO alerts. Some intervene to help trial participants, but are not able to record this intervention in the trial documentation, risking co-intervention bias. Other staff do not check PRO information during the trial, meaning alerts may remain undiscovered, or do not respond to alerts if they are inadvertently encountered; both of which may impact on patient safety. Guidance is needed to support PRO alert management that protects the interests of trial participants whilst avoiding potential bias. [ABSTRACT FROM AUTHOR]

In recent years there has been a wealth of literature arguing the need for empirical and interdisciplinary approaches to bioethics, based on the premise that an empirically informed ethical analysis is more grounded, contextually sensitive and therefore more relevant to clinical practice than an 'abstract' philosophical analysis. Bioethics has (arguably) always been an interdisciplinary field, and the rise of 'empirical' (bio)ethics need not be seen as an attempt to give a new name to the longstanding practice of interdisciplinary collaboration, but can perhaps best be understood as a substantive attempt to engage with the nature of that interdisciplinarity and to articulate the relationship between the many different disciplines (some of them empirical) that contribute to the field. It can also be described as an endeavour to explain how different disciplinary approaches can be integrated to effectively answer normative questions in bioethics, and fundamental to that endeavour is the need to think about how a robust methodology can be articulated that successfully marries apparently divergent epistemological and metaethical perspectives with method. This paper proposes ' Reflexive Bioethics' ( RB) as a methodology for interdisciplinary and empirical bioethics, which utilizes a method of ' Reflexive Balancing' ( RBL). RBL has been developed in response to criticisms of various forms of reflective equilibrium, and is built upon a pragmatic characterization of Bioethics and a 'quasi-moral foundationalism', which allows RBL to avoid some of the difficulties associated with RE and yet retain the flexible egalitarianism that makes it intuitively appealing to many. [ABSTRACT FROM AUTHOR]

Altruism has long been taken to be the guiding principle of ethical organ donation in the UK, and has been used as justification for rejecting or allowing certain types of donation. We argue that, despite this prominent role, altruism has been poorly defined in policy and position documents, and used confusingly and inconsistently. Looking at how the term has been used over recent years allows us to define 'organ donation altruism', and comparing this with accounts in the philosophical literature highlights its theoretical shortcomings. The recent report from the Nuffield Council on Bioethics reaffirmed the importance of altruism in organ donation, and offered a clearer definition. This definition is, however, more permissive than that of altruism previously seen in UK policy, and as a result allows some donations that previously have been considered unacceptable. We argue that while altruistic motivation may be desirable, it is not necessary. [ABSTRACT FROM AUTHOR]

Abstract: Background: Depression following first episode psychosis (FEP) is a frequent occurrence, with profound impact on recovery and outcome. Whilst many theories exist about the causes of depression here, research to date has been based on nosology imported wholesale from affective disorder, with little primary research on the subjective experience. This study aimed to explore the subjective experience and phenomenological features of post-psychotic depression in FEP. Method: A qualitative methodology, photo-elicitation, together with unstructured interviews, was used to characterise aspects of depression following FEP and analysed using contemporary framework analysis. Results: Depression was reported by participants as linked to the experience of and recovery from psychosis. The psychotic episode was a traumatic event followed by subjective doubt, shame and embarrassment. Loss and social isolation were central. Core biological symptoms did not feature. Limitations: Despite the relatively small sample size, this study was able to generate in-depth data that provides useful and novel insight. Whilst generalisability is incompatible with qualitative methodology, further research using the same methodology would generate a wider range of experiences and perspectives. Conclusions: Understanding this dimension of psychosis in and of itself has the potential to improve and aid development of more effective and appropriately targeted interventions and associated outcomes. [Copyright &y& Elsevier]

Bioethics is an interdisciplinary field that accommodates a broad range of perspectives and disciplines. This inherent diversity sets a number of challenges for both teachers and students of bioethics, notably in respect to the appropriate aims and methods of bioethics education, standards and criteria for evaluating performance and disciplinary identity. The Interdisciplinary and Empirical Ethics Network (IEEN) was established, with funding from the Wellcome Trust, to facilitate critical and constructive discussion about the ongoing development of bioethics as an evolving field of interdisciplinary study. In November 2012 the IEEN organised a workshop at the University of Birmingham to discuss the issues relating to teaching and learning in interdisciplinary and empirical bioethics. This paper reports on that meeting. [ABSTRACT FROM PUBLISHER]

Over the last decade, patient and public involvement (PPI) has become a requisite in applied health research. Some funding bodies demand explicit evidence of PPI, while others have made a commitment to developing PPI in the projects they fund. Despite being commonplace, there remains a dearth of engagement with the ethical and theoretical underpinnings of PPI processes and practices. More specifically, while there is a small (but growing) body of literature examining the effectiveness and impact of PPI, there has been relatively little reflection on whether the concept/practice of PPI is internally coherent. Here, the authors unpick a 'paradox' within PPI, which highlights a tension between its moral and pragmatic motivations and its implementation. The authors argue that this 'professionalisation paradox' means we need to rethink the practice, and purpose, of PPI in research. [ABSTRACT FROM AUTHOR]

The article compares standard questionnaire-based evaluation with nominal group technique (NGT) in higher education setting. It mentions that module evaluation is important for the purpose of external and internal quality assurance and to monitor and improve the student experience. Standard evaluation tended to generate short answers while NGT allowed in-depth exploration of students' views and provided ways to enhance learning, negotiate, and propose shared solutions to any conflicting views.

Bioethics is a diverse field that accommodates a broad range of perspectives and disciplines. The recent explosion of literature on methods in interdisciplinary and empirical ethics might appear, however, to overshadow the fact that 'bioethics' has long been an interdisciplinary field. The Interdisciplinary and Empirical Ethics Network (IEEN) was established, with funding from the Wellcome Trust, to facilitate critical and constructive discussion around the nature of this disciplinary diversity and shift focus away from the 'empirical turn', towards the ongoing development of bioethics as an evolving field of interdisciplinary study. In April 2012 the IEEN organized a workshop at the Centre for Public Policy Research, King's College London, dedicated to discussing the relationship between aims and methods in interdisciplinary and empirical bioethics. This paper reports on that first meeting. [ABSTRACT FROM AUTHOR]

In this paper we set forth what we believe to be a relatively controversial argument, claiming that ‘bioethics’ needs to undergo a fundamental change in the way it is practised. This change, we argue, requires philosophical bioethicists to adopt reflexive practices when applying their analyses in public forums, acknowledging openly that bioethics is an embedded socio-cultural practice, shaped by the ever-changing intuitions of individual philosophers, which cannot be viewed as a detached intellectual endeavour. This said, we argue that in order to manage the personal, social and cultural embeddedness of bioethics, philosophical bioethicists should openly acknowledge how their practices are constructed and should, in their writing, explicitly deal with issues of bias and conflict of interest, just as empirical scientists are required to do. [ABSTRACT FROM AUTHOR]

In this paper we argue that there are few morally acceptable justifications for a man to seek a paternity test. The relationship between material responsibility and the burdens generated by the creation of a needy child, means it is not unreasonable for a man to establish that he is responsible for the creation of a child before accepting this financial responsibility. Some men embrace fatherhood irrespective of their involvement in the children's creation and in the absence of a genetic relationship. Others feel differently. Given that parenting is a life-long commitment it is reasonable for those for whom genetics matters to request a paternity test prior to making this commitment. Once a man has become a (moral) father there is no justification for initiating paternity testing, save in the interests of the child. Where the child's interest in knowing his/her genetic origins is unclear we argue this is a decision that can be left for the child to make for him/herself when he/she is sufficiently mature. There is no justification for performing infidelity testing on a child. Because fatherhood is not contingent on genetic relatedness, suspicion of misattributed paternity is no justification for paternity testing. The justifications for, and problems with, paternity testing suggest that it is something men should seek antenatally, at birth or not at all. [ABSTRACT FROM AUTHOR]

In the third of a series of articles examining ethical issues in primary care research, we argue that family doctors, when considering what they ought to do in relation to research, have a positive obligation to participate in research and that one means of discharging this obligation is to collaborate in research studies by aiding recruitment. We offer three arguments in support of this obligation–arguments from fairness, reason and utility. We then go on to specify a series of conditions on this obligation which take into account that doctors have many other obligations. These are the conditions of financial remuneration, reciprocity and ability. [ABSTRACT FROM PUBLISHER]

In this article we distinguish between philosophical bioethics (PB), descriptive policy orientated bioethics (DPOB) and normative policy oriented bioethics (NPOB). We argue that finding an appropriate methodology for combining empirical data and moral theory depends on what the aims of the research endeavour are, and that, for the most part, this combination is only required for NPOB. After briefly discussing the debate around the is/ought problem, and suggesting that both sides of this debate are misunderstanding one another (i.e. one side treats it as a conceptual problem, whilst the other treats it as an empirical claim), we outline and defend a methodological approach to NPOB based on work we have carried out on a project exploring the normative foundations of paternal rights and responsibilities. We suggest that given the prominent role already played by moral intuition in moral theory, one appropriate way to integrate empirical data and philosophical bioethics is to utilize empirically gathered lay intuition as the foundation for ethical reasoning in NPOB. The method we propose involves a modification of a long-established tradition on non-intervention in qualitative data gathering, combined with a form of reflective equilibrium where the demands of theory and data are given equal weight and a pragmatic compromise reached. [ABSTRACT FROM AUTHOR]

Background: Healthcare workers (HCWs) will play a key role in any response to pandemic influenza, and the UK healthcare system's ability to cope during an influenza pandemic will depend, to a large extent, on the number of HCWs who are able and willing to work through the crisis. UK emergency planning will be improved if planners have a better understanding of the reasons UK HCWs may have for their absenteeism, and what might motivate them to work during an influenza pandemic. This paper reports the results of a qualitative study that explored UK HCWs' views (n = 64) about working during an influenza pandemic, in order to identify factors that might influence their willingness and ability to work and to identify potential sources of any perceived duty on HCWs to work. Methods: A qualitative study, using focus groups (n = 9) and interviews (n = 5). Results: HCWs across a range of roles and grades tended to feel motivated by a sense of obligation to work through an influenza pandemic. A number of significant barriers that may prevent them from doing so were also identified. Perceived barriers to the ability to work included being ill oneself, transport difficulties, and childcare responsibilities. Perceived barriers to the willingness to work included: prioritising the wellbeing of family members; a lack of trust in, and goodwill towards, the NHS; a lack of information about the risks and what is expected of them during the crisis; fear of litigation; and the feeling that employers do not take the needs of staff seriously. Barriers to ability and barriers to willingness, however, are difficult to separate out. Conclusion: Although our participants tended to feel a general obligation to work during an influenza pandemic, there are barriers to working, which, if generalisable, may significantly reduce the NHS workforce during a pandemic. The barriers identified are both barriers to willingness and to ability. This suggests that pandemic planning needs to take into account the possibility that staff may be absent for reasons beyond those currently anticipated in UK planning documents. In particular, staff who are physically able to attend work may nonetheless be unwilling to do so. Although there are some barriers that cannot be mitigated by employers (such as illness, transport infrastructure etc.), there are a number of remedial steps that can be taken to lesson the impact of others (providing accommodation, building reciprocity, provision of information and guidance etc). We suggest that barriers to working lie along an ability/willingness continuum, and that absenteeism may be reduced by taking steps to prevent barriers to willingness becoming perceived barriers to ability. [ABSTRACT FROM AUTHOR]

In this paper, we present the first stage of an empirical bioethics project exploring the moral sources of paternal responsibilities and rights. In doing so, we present both (1) data on men's normative constructions of fatherhood and (2) the first of a two-stage methodological approach to empirical bioethics. Using data gathered from 12 focus groups run with UK men who have had a variety of different fathering experiences (n = 50), we examine men's perspectives on how paternal responsibilities and rights are generated and the significance of the genetic connection within the father-child relationship. We do not attempt to explore men's experiences of fatherhood or their fathering practices; and neither is the analysis driven from a particular sociological perspective. Rather, we explore men's normative constructions of fatherhood in order to present accessible data that might be of significance to the philosophical/moral debate on the sources of paternal rights and responsibilities. [ABSTRACT FROM AUTHOR]

In 1997, the Wellcome Trust Biomedical Ethics programme was launched in the UK, with a strategy that sought to encourage bioethics research that married normative philosophical bioethics and social science methodologies. This paper explores a few of the children of this marriage, particularly those approaches that have been taken in an attempt to make this interdisciplinary marriage a happy one. We suggest that the dominant discourse has involved social science for bioethics, and sociology of bioethics, and we suggest further that neither of these approaches represent a happy and equal marriage. We then outline a third approach: social science in bioethics. Drawing upon our experiences of conducting such a project we describe the broad methodological approach that we have taken, and outline how, and why, this approach might be productive. [ABSTRACT FROM AUTHOR]

The article argues that the term "autonomous" is misused in the tech industry when describing systems. While these systems may appear independent, they are actually constrained by goals set by human controllers and cannot choose their own goals. The article emphasizes that true autonomy involves the capacity for self-rule and the ability to determine one's own goals. The misuse of the term "autonomous" can have implications for responsibility and rights, as well as potentially divert attention from those responsible for designing and operating these systems. The authors suggest terminating the use of the term "autonomous systems." [Extracted from the article]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

In this article the authors discuss the difference between empirical facts and normative ethical analysis in a social constructivist aspect. They argue that the nature of empirical research, especially in considering the relationship between philosophy and the social sciences, must be discussed in the development of empirical bioethics. They also believe that questioning the possibility of obtaining empirical data that reveals "how something is" is needed to discover "how something ought to be."

Engagement with genomic medicine and research has increased globally during the past few decades, including rapid developments in Sri Lanka. Genomic research is carried out in Sri Lanka on a variety of scales and with different aims and perspectives. However, there are concerns about participants' understanding of genomic research, including the validity of informed consent. This article reports a qualitative study aiming to explore the understanding, knowledge, and attitudes of the Sri Lankan public towards genomic medicine and to inform the development of an effective and appropriate process for informed consent in that setting. Purposive sampling was employed. Participants were recruited from a sub-group of the public in Colombo, Sri Lanka who had either consented or refused to donate genetic material for a biobank. Data were collected using face-to-face semi-structured interviews. Interview data were transcribed verbatim and translated into English. Conventional content analysis was used. The analysis developed three key themes: a) 'Scientific literacy' describes an apparent lack of scientific knowledge that seems to affect a participant's ability to understand the research, b) 'Motivation' describes narratives about why participants chose (not) to take part in the research, despite not understanding it, and c) 'Trust' describes how trust served to mitigate the apparent ethical deficit created by not being fully informed. In this article, we argue that informed trust is likely an acceptable basis for consent, particularly in settings where scientific literacy might be low. However, researchers must work to be worthy of that trust and ensure that misconceptions are actively addressed. [ABSTRACT FROM AUTHOR]

In 'A Conceptual Model for the Translation of Bioethics Research and Scholarship,' Debra Mathews et al. aim to 'begin an important discussion' about how to measure success in bioethics, and in doing so they set out a typology of bioethics research and scholarship with the arguably correct assumption that we cannot evaluate success in bioethics without first understanding what its goals are. I think the authors are correct in their claim that, in the current academic climate, having work in bioethics deemed a success is likely to hinge, in some way, on its being translated into practice and having impact. I want, however, to add a critical voice in the form of three considerations that I feel ought to be attended to before the work progresses further, the first being that the typology Mathews et al. propose is highly problematic. Although there is a burgeoning literature on 'empirical bioethics' methodologies that blend empirical and conceptual work, the typology appears to ignore this. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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'. [ABSTRACT FROM AUTHOR]

Background: Recruitment to intrapartum research is complex. Women are expected to understand unfamiliar terminology and assess potential harm versus benefit to their baby and themselves, often when an urgent intervention is required. Time pressures of intrapartum interventions are a major challenge for recruitment discussions taking place during labour, with research midwives expected to present, discuss and answer questions whilst maintaining equipoise. However, little is known about these interactions. An integrated qualitative study (IQS) was used to investigate information provision for women invited to participate in the Assist II feasibility study investigating the OdonAssist™—a novel device for use in assisted vaginal birth with an aim to generate a framework of good practice for information provision. Methods: Transcripts of in-depth interviews with women participants (n = 25), with recruiting midwives (n = 6) and recruitment discussions between midwives and women (n = 21), accepting or declining participation, were coded and interpreted using thematic analysis and content analysis to investigate what was helpful to women and what could be improved. Results: Recruiting women to intrapartum research is complicated by factors that impact on women's understanding and decision-making. Three key themes were derived from the data: (i) a woman-centred recruitment process, (ii) optimising the recruitment discussion and (iii) making a decision for two. Conclusion: Despite evidence from the literature that women would like information provision and the research discussion to take place in the antenatal period, intrapartum studies still vary in the recruitment processes they offer women. Particularly concerning is that some women are given information for the first time whilst in labour, when they are known to feel particularly vulnerable, and contextual factors may influence decision-making; therefore, we propose a framework for good practice for information provision for research involving interventions initiated in the intrapartum period as a woman centred, and acceptable model of recruitment, which addresses the concerns of women and midwives and facilitates fair inclusion into intrapartum trials. Trial registration: ISRCTN. This qualitative research was undertaken as part of the ASSIST II Trial (trial registration number: ISRCTN38829082. Prospectively registered on 26/06/2019). [ABSTRACT FROM AUTHOR]

Background:Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem. Methods And Findings:We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden. Conclusions:Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting researchers to carry out high quality data collection. [ABSTRACT FROM AUTHOR]

The article reports on the innovative practice in healthcare which is based on evidence, experience, and judgment. Topics discussed focuses on surgical practice endovascular and techniques in neurosurgery; mentions the standard surgical procedures that modified to in patient anatomy; and information on to protect patient safety and protect surgeons and the impact of innovations.

Auditory 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. This study aimed to explore patients' understanding and self-management of AVH in a young adult clinical population. 35 participants were purposively sampled from a youth mental health service. Participants completed diary and photo-elicitation tasks, and the resulting materials were discussed at in-depth interviews. Themes were derived using conventional content analysis. Three themes emerged. (1) Searching for answers, forming identities – voice-hearers sought to explain their experiences, resulting in the construction of identities for voices and themselves. Explanations were drawn from participants' life-stories and belief-systems. (2) Coping goals – patients' self-management strategies were diverse, reflecting the diverse negative experience of AVH, e.g. as distressing sounds, overwhelming emotions, or as threats to agency. (3) Outlook – participants formed an overall outlook on their life with AVH. Resignation and hopelessness in connection with disabling AVH are contrasted with "acceptance" or integration, described as positive, ideal, or mature. Trans-diagnostic commonalities in understanding and self-management of AVH are highlighted. These offer targets for individual therapies and further research. [ABSTRACT FROM AUTHOR]

The Interdisciplinary and Empirical Ethics Network was established in 2012 with funding from the Wellcome Trust in order to facilitate critical and constructive discussion around the nature of the disciplinary diversity within bioethics and to consider the ongoing development of bioethics as an evolving field of interdisciplinary study. In April 2013, the Interdisciplinary and Empirical Ethics Network organized a workshop at the Centre for Public Policy Research, King’s College London, which discussed the nature and possibility of professionalism within interdisciplinary and empirical bioethics. This paper provides a report of that workshop. [ABSTRACT FROM PUBLISHER]

Background: Patient reported outcomes (PROs) are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on ‘in-trial’ activity (recruitment, data collection and data inputting) and the management of ‘concerning’ PRO data (i.e., data which raises concern for the well-being of the trial participant) appears to be lacking. The purpose of this review was to determine the extent and nature of published guidelines addressing these areas. Methods and Findings: Systematic review of 1,362 articles identified 18 eligible papers containing ‘in-trial’ guidelines. Two independent authors undertook a qualitative content analysis of the selected papers. Guidelines presented in each of the articles were coded according to an a priori defined coding frame, which demonstrated reliability (pooled Kappa 0.86–0.97), and validity (<2% residual category coding). The majority of guidelines present were concerned with ‘pre-trial’ activities (72%), for example, outcome measure selection and study design issues, or ‘post-trial’ activities (16%) such as data analysis, reporting and interpretation. ‘In-trial’ guidelines represented 9.2% of all guidance across the papers reviewed, with content primarily focused on compliance, quality control, proxy assessment and reporting of data collection. There were no guidelines surrounding the management of concerning PRO data. Conclusions: The findings highlight there are minimal in-trial guidelines in publication regarding PRO data collection and management in clinical trials. No guidance appears to exist for researchers involved with the handling of concerning PRO data. Guidelines are needed, which support researchers to manage all PRO data appropriately and which facilitate unbiased data collection. [ABSTRACT FROM AUTHOR]

Background: The rationale for centre selection in randomised controlled trials (RCTs) is often unclear but may have important implications for the generalisability of trial results. The aims of this study were to evaluate the factors which currently influence centre selection in RCTs and consider how generalisability considerations inform current and optimal practice. Methods and Findings: Mixed methods approach consisting of a systematic review and meta-summary of centre selection criteria reported in RCT protocols funded by the UK National Institute of Health Research (NIHR) initiated between January 2005-January 2012; and an online survey on the topic of current and optimal centre selection, distributed to professionals in the 48 UK Clinical Trials Units and 10 NIHR Research Design Services. The survey design was informed by the systematic review and by two focus groups conducted with trialists at the Birmingham Centre for Clinical Trials. 129 trial protocols were included in the systematic review, with a total target sample size in excess of 317,000 participants. The meta-summary identified 53 unique centre selection criteria. 78 protocols (60%) provided at least one criterion for centre selection, but only 31 (24%) protocols explicitly acknowledged generalisability. This is consistent with the survey findings (n = 70), where less than a third of participants reported generalisability as a key driver of centre selection in current practice. This contrasts with trialists’ views on optimal practice, where generalisability in terms of clinical practice, population characteristics and economic results were prime considerations for 60% (n = 42), 57% (n = 40) and 46% (n = 32) of respondents, respectively. Conclusions: Centres are rarely enrolled in RCTs with an explicit view to external validity, although trialists acknowledge that incorporating generalisability in centre selection should ideally be more prominent. There is a need to operationalize ‘generalisability’ and incorporate it at the design stage of RCTs so that results are readily transferable to ‘real world’ practice. [ABSTRACT FROM AUTHOR]

Most academic papers on ethics in pandemics concentrate on the duties of healthcare professionals. This paper will consider non-professional healthcare workers: do they have a moral obligation to work during an influenza pandemic? If so, is this an obligation that outweighs others they might have, e.g., as parents, and should such an obligation be backed up by the coercive power of law? This paper considers whether non-professional healthcare workers—porters, domestic service workers, catering staff, clerks, IT support workers, etc.—have an obligation to work during an influenza pandemic. It uses data collected as part of a study looking at the attitudes of healthcare workers to working during a pandemic to suggest the philosophical arguments explored. These include: being in a position to do good, the ethics of work, competing obligations to family members and in particular to children and the obligations of citizens in a state of national emergency. We also look at whether compulsory measures are justified to support a national health service during a health emergency. We conclude that even if they are, compulsion should not be restricted to non-professionals who happen to be working in the health service at the time. Rather, compulsion involving a larger pool of people with the relevant skills and abilities is more equitable. [ABSTRACT FROM PUBLISHER]

Background: Healthcare workers (HCWs) will be key players in any response to pandemic influenza, and will be in the front line of exposure to infection. Responding effectively to a pandemic relies on the majority of medical, nursing, laboratory and hotel services staff continuing to work normally. Planning assumes that during a pandemic normal healthcare service levels will be provided, although it anticipates that as caseloads increase only essential care will be provided. The ability of the NHS to provide expected service levels is entirely dependent upon HCWs continuing to work as normal. Methods/design: This study is designed as a two-phase multi-method study, incorporating focus groups and a questionnaire survey. In phase one, qualitative methods will be used to collect the views of a purposive sample of HCWs, to determine the range of factors associated with their responses to the prospect of working through pandemic influenza. In phase two, the findings from the focus groups, combined with the available literature, will be used to inform the design of a survey to determine the generalisability of these factors, enabling the estimation of the likely proportion of HCWs affected by each factor, and how likely it is that they would be willing and/or able to continue to work during an influenza pandemic. Discussion: There are potentially greater than normal health risks for some healthcare workers working during a pandemic, and these workers may be concerned about infecting family members/ friends. HCWs will be as liable as other workers to care for sick family members and friends. It is vital to have information about how motivated HCWs will be to continue to work during such a crisis, and what factors might influence their decision to work/not to work. Through the identification and subsequent management of these factors it may be possible to implement strategies that will alleviate the concerns and fears of HCWs and remove potential barriers to working. [ABSTRACT FROM AUTHOR]

The field experiments presented here investigated the required thickness of wood waste materials used as a mulch to protect a soil slope against erosion. Each of the materials was subjected to large-scale erosion control testing at a field site with a slope of 1 vertical to 2 horizontal. Fourteen test cells (5′ W x 30′ L each) were prepared with different wood waste treatments; nine contained erosion control mulch applications at thicknesses of 3/4 to 3 inch. Two cells were left untreated as reference cells and three other cells were untreated but contained erosion control structures including wood waste filter berm, geosynthetic silt fence and hay bale silt barrier. The erosion control performance of each cell treatment was evaluated for 11 storm events of varying rainfall magnitude and intensity. Calibrated tipper buckets were used to measure the runoff from each cell and collection buckets were used to sample runoff and determine the mass of sediment eroded from each cell. Total rainfall and intensity of each storm was measured with an electronic rain gauge. The results showed that 0.75 inches of wood waste material is sufficient to reduce the erosion to levels below commonly used treatments. Using thicker applications of wood waste did not reduce the erosion much below that obtained with 0.75 inches. This effect was demonstrated with three different wood waste materials. In addition, one of the wood wastes (paper mill wood waste) was used as a filter berm to control eroded soil particles. The behavior of this berm was compared to standard methods of controlling these particles such as hay bales and geosynthetic silt fence, and found superior. Laboratory tests are planned to quantify the properties of wood waste that produce good filtering action in berms. [ABSTRACT FROM AUTHOR]