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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.

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]

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.

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]

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]

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., Author(s): Alexander Burrell [sup.1] , Jonathan Ives [sup.2] , Gemma Unwin [sup.3] Author Affiliations: (1) 0000 0004 1936 7486grid.6572.6College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK (2) [...]

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]

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]

To authenticate to the full-text of this article, please visit this link: http://dx.doi.org/10.1111/j.1467-8519.2010.01809.x Byline: JONATHAN IVES (1), MICHAEL DUNN (2) Keywords: bioethics; reflexivity; critical bioethics; empirical bioethics; moral intuition; moral assumption Abstract: ABSTRACT 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. Author Affiliation: (1)School of Health and Population Sciences, the University of Birmingham (2)Ethox Centre, University of Oxford Article note: Dr Jonathan Ives, Centre for Biomedical Ethics, Primary Care Clinical Sciences, The University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK. Email: j.c.ives@bham.ac.uk

To authenticate to the full-text of this article, please visit this link: http://dx.doi.org/10.1111/j.1467-8519.2009.01715.x Byline: JONATHAN IVES (1), HEATHER DRAPER (1) Keywords: empirical bioethics; methodology; integrated ethics; Is/ought problem; normative policy orientated bioethics; focus groups; reflective equilibrium Abstract: ABSTRACT 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. Author Affiliation: (1)Centre for Biomedical Ethics, The University of Birmingham Article note: Dr Jonathan Ives, Centre for Biomedical Ethics, Primary Care Clinical Sciences, The University of Birmingham, Edgbaston, Birmingham, B15 2TT. j.c.ives@bham.ac.uk

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]