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This paper will take as its starting point the premise that developing translational bioethics is a worthwhile endeavour. I will develop an account of translational bioethics and discuss what implications this would have for the wider discipline of bioethics and argue that this would be a useful development for bioethics. The paper will conduct a form of 'translational meta‐bioethics analysis', in the words of Bærøe. I will argue that if we are serious about instituting translational bioethics, then it will need to look and be organised in a very different way from current bioethics research, this will be a radically different form of bioethics from what we currently have. In this paper I will sketch what translational bioethics might look like. My proposal here is not that translational bioethics should supplant existing ways of doing bioethics, but rather that it should be an addition to it, another subdiscipline of bioethics. [ABSTRACT FROM AUTHOR]

Background: Big data research requires public support. It has been argued that this can be achieved by public involvement and engagement to ensure that public views are at the centre of research projects. Researchers should aim to include diverse communities, including seldom‐heard voices, to ensure that a range of voices are heard and that research is meaningful to them. Objective: We explored how researchers involve and engage seldom‐heard communities around big data research. Methods: This is a qualitative study. Researchers who had experience of involving or engaging seldom‐heard communities in big data research were recruited. They were based in England (n = 5), Scotland (n = 4), Belgium (n = 2) and Canada (n = 1). Twelve semistructured interviews were conducted on Zoom. All interviews were audio‐recorded and transcribed, and we used reflexive thematic analysis to analyse participants' experiences. Results: The analysis highlighted the complexity of involving and engaging seldom‐heard communities around big data research. Four themes were developed to represent participants' experiences: (1) abstraction and complexity of big data, (2) one size does not fit all, (3) working in partnership and (4) empowering the public contribution. Conclusion: The study offers researchers a better understanding of how to involve and engage seldom‐heard communities in a meaningful way around big data research. There is no one right approach, with involvement and engagement activities required to be project‐specific and dependent on the public contributors, researchers' needs, resources and time available. Patient and Public Involvement: Two public contributors are authors of the paper and they were involved in the study design, analysis and writing. [ABSTRACT FROM AUTHOR]

Introduction: Covid‐19 expanded the use of remote working to engage with public contributors in health and social care research. These changes have the potential to limit the ability to participate in patient and public involvement and engagement (PPIE) for some public contributors. It is therefore important to understand public contributors' preferences, so that remote working can be organized in an optimal way to encourage rather than discourage participation. Methods: We use an economic preference elicitation tool, a discrete choice experiment (DCE), via an online survey, to estimate public contributors' preferences for and trade‐offs between different features of remote meetings. The features were informed by previous research to include aspects of remote meetings that were relevant to public contributors and amenable to change by PPIE organizers. Results: We found that public contributors are more likely to participate in a PPIE project involving remote meetings if they are given feedback about participation; allowed to switch their camera off during meetings and step away if/when needed; were under 2.5 h long; organized during working hours, and are chaired by a moderator who can ensure that everyone contributes. Different combinations of these features can cause estimated project participation to range from 23% to 94%. When planning PPIE and engaging public contributors, we suggest that resources are focused on training moderators and ensuring public contributors receive meeting feedback. Discussion and Conclusion: Project resources should be allocated to maximize project participation. We provide recommendations for those who work in public involvement and organize meetings on how resources, such as time and financial support, should be allocated. These are based on the preferences of existing public contributors who have been involved in health and social care research. Patient or Public Contribution: We had a public contributor (Naheed Tahir) as a funded coapplicant on the UKRI ESRC application and involved members of the North West Coast Applied Research Collaboration (NWC ARC) Public Advisor Forum at every stage of the project. The survey design was informed from three focus groups held with NWC ARC public contributors. The survey was further edited and improved based on the results of six one‐to‐one meetings with public contributors. [ABSTRACT FROM AUTHOR]

Aim: Pragmatic clinical trials (PCTs) are randomized trials implemented through routine clinical practice, where design parameters of traditional randomized controlled trials are modified to increase generalizability. However, this may introduce statistical challenges. We aimed to identify these challenges and discuss possible solutions leading to best practice recommendations for the design and analysis of PCTs. Methods: A modified Delphi method was used to reach consensus among a panel of 11 experts in clinical trials and statistics. Statistical issues were identified in a focused literature review and aggregated with insights and possible solutions from experts collected through a series of survey iterations. Issues were ranked according to their importance. Results: Twenty‐seven articles were included and combined with experts' insight to generate a list of issues categorized into participants, recruiting sites, randomization, blinding and intervention, outcome (selection and measurement) and data analysis. Consensus was reached about the most important issues: risk of participants' attrition, heterogeneity of "usual care" across sites, absence of blinding, use of a subjective endpoint and data analysis aligned with the trial estimand. Potential issues should be anticipated and preferably be addressed in the trial protocol. The experts provided solutions regarding data collection and data analysis, which were considered of equal importance. Discussion: A set of important statistical issues in PCTs was identified and approaches were suggested to anticipate and/or minimize these through data analysis. Any impact of choosing a pragmatic design feature should be gauged in the light of the trial estimand. [ABSTRACT FROM AUTHOR]

Community engagement (CE) contributes to successful research. There is, however, a lack of literature on the effectiveness of different models of CE and, specifically, on CE strategies for the conduct of genomic research in sub‐Saharan Africa. There is also a need for models of CE that transcend the recruitment stage of engaging prospective individuals and communities and embed CE throughout the research process and after the research has concluded. The qualitative study reported here was designed to address these knowledge gaps and comprised of 36 key informant semi‐structured interviews and fifteen focus groups with 50 participants. We interviewed selected stakeholders in genomic research in Nigeria: biomedical researchers, community rulers, opinion leaders, community health workers, and prospective research participants. We explored these stakeholders' views on their understanding of community engagement, their expectations, experiences, and their opinions on acceptable processes of community consultation in genomic research. The methodological design, adapted from grounded theory, used the constant comparative method of data analysis; while normative conclusions were made using the symbiotic empirical ethics approach. Data analysis revealed five main themes important for successfully engaging communities in genomic research: effective communication, diversity of community gatekeeping, trust, cultural integration of research, and conservation of the research setting. From these themes, we have developed a four‐stage model of community engagement that covers all stages of the research process; namely, the Community Approach, Intermediate phase, Collaboration and Post‐research Cordiality model (CICP). This model could be used to improve the integration of CE in genomic research among local communities. [ABSTRACT FROM AUTHOR]

This article advances the case for a 'sociology of donation'. We aim to establish that there is a need for such a sociology, to bring together the many, often disparate, elements that make up the theorizing, practice and experience of donation. We argue that bringing together different forms of donation illuminates the distinctive place both in social meaning and regulation that the body and its products hold. In developing this, we are primarily focusing on the donation of body parts and body products within high‐income countries. We will first outline the standard western accounts of donation, and consider how relevant these are to donation practices and policies in the 21st century. We will then critically discuss how a sociology of donation can be used to further current understandings of 'donation' and identify the challenges facing such a proposal, posing questions to encourage reflection on research practices in this area. Finally, we will explore what a sociology of donation might entail. [ABSTRACT FROM AUTHOR]

This article discusses when it is ethically acceptable to withdraw consent for the storage and use of embryos and gametes. Currently, the law in the UK states that consent to use of a gamete or embryo can be withdrawn up to the point of the embryo's transfer to the recipient's uterus or when the gamete is used in providing treatment services; that is, the 'point of no return'. In this article, we will consider other points of no return and argue that having a single point of no return, a one size fits all form of consent can, in some cases, lead to restrictions on individuals' autonomy and cause particular types of harm. Therefore, having different points of no return that fit different circumstances could extend autonomy and allow people to enter into agreements that are tailored more to their own particular needs and circumstances. [ABSTRACT FROM AUTHOR]

An introduction is presented to a section on the sociology of organ donation, noting articles on topics including the role of altruism in kidney donation and breastmilk sharing, the notion of tissue donation as a gendered practice, and the sociology of contributions to health research.

Abstract: This article considers the disclosure, sharing and exchange of information on being donor conceived within families, drawing on data from a study undertaken with donor‐conceived adults registered with UK Donor Link (a voluntary DNA‐linking register). This paper considers the narratives of how respondents found out they were donor‐conceived and what events triggered disclosure of this information. This paper then goes on to examine the role secrecy played in their family life and uses the concept of ‘display’ to explore how secrecy affected their relationships with their immediate and extended family. Secrets are notoriously ‘leaky’ and we found complex patterns of knowing and uncertainty about whom in the family knew that the person was donor‐conceived. We argue that what is kept secret and from whom provides insights into the multifaceted web of social relationships that can be created by donor‐conception, and how knowledge can be managed and controlled in attempts to display and maintain family narratives of biogenetic connection. [ABSTRACT FROM AUTHOR]

Recently the World Health Organization (WHO) has highlighted the need to strengthen mental health systems following emergencies, including natural and manmade disasters. Mental health services need to be informed by culturally attuned evidence that is developed through research. Therefore, there is an urgent need to establish rigorous ethical research practice to underpin the evidence-base for mental health services delivered during and following emergencies. [ABSTRACT FROM AUTHOR]

There are substantial numbers of frozen embryos in storage that will not be used by those who produced them for their own fertility treatment. One option for such embryos is to donate them to others to use in their fertility treatment. There has been considerable debate about how this process should be organized. In the US, there are embryo adoption programmes that mediate between those relinquishing embryos and potential recipients. This is a form of conditional embryo donation, where the relinquishing couple can choose the recipient of their embryo. This article examines the ethical debate over conditional embryo donation for family building and explores the question of whether those who have unused frozen embryos should be able to determine who receives their embryos. The main objections to conditional embryo donation are examined: first, the embryo is not a person and therefore such concern over the placement of an embryo is unwarranted; secondly, potential donors might impose morally problematic conditions on who should receive their embryo; and thirdly, there are practical difficulties regarding organizational arrangements and the associated costs involved. It will be concluded that these objections can be countered and that if people wish to donate and receive embryos in this way there is no ethical objection to them doing so. [ABSTRACT FROM AUTHOR]

ABSTRACT Like any discipline, bioethics is a developing field of academic inquiry; and recent trends in scholarship have been towards more engagement with empirical research. This 'empirical turn' has provoked extensive debate over how such 'descriptive' research carried out in the social sciences contributes to the distinctively normative aspect of bioethics. This paper will address this issue by developing a practical research methodology for the inclusion of data from social science studies into ethical deliberation. This methodology will be based on a naturalistic conception of ethical theory that sees practice as informing theory just as theory informs practice - the two are symbiotically related. From this engagement with practice, the ways that such theories need to be extended and developed can be determined. This is a practical methodology for integrating theory and practice that can be used in empirical studies, one that uses ethical theory both to explore the data and to draw normative conclusions. [ABSTRACT FROM AUTHOR]

The use of rights based arguments to justify claims that donor offspring should have access to information identifying their gamete donor has become increasingly widespread. In this paper, I do not intend to revisit the debate about the validity of such rights. Rather, the purpose is to examine the way that such alleged rights have been implemented by those legislatures that have allowed access to identifying information. I will argue that serious inconsistencies exist between the claim that donor offspring have a right to know the identity of their gamete donor and the way such a right is currently met in practice. I hope to show that in systems where non-anonymous donation is practised, an understanding of the proclaimed right of donor offspring to know their genetic identity is one composed of two different rights – the right to know the circumstances of their conception and the right to information identifying the gamete donor – can provide important insights into this important area of public policy. [ABSTRACT FROM AUTHOR]

The article discusses various reports published within the issue, including one by Rob De Vries and Bert Gordijn on "Empirical Ethics and Its Alleged Meta-ethical Fallacies," one by Malcolm Parker on "Two Concepts of Empirical Ethics," and another by Barry Hoffmaster and Cliff Hooker on "How Experience Confronts Ethics."