Translational or translationable? A call for ethno-immersion in (empirical) bioethics research.

The shift towards "empirical bioethics" was largely triggered by a recognition that stakeholders' views and experiences are vital in ethical analysis where one hopes to produce practicable recommendations. Such perspectives can provide a rich resource in bioethics scholarship, perhaps challenging the researcher's perspective. However, overreliance on a picture painted by a group of research participants-or on pre-existing literature in that field-can lead to a biased view of a given context, as the subjectivity of data generated in these ways cannot (and should not wholly) be escaped. In response, we propose the implementation of a complementary approach of ethno-immersion in bioethics research. By positioning oneself in the context being researched, the researcher can better understand the realities of that context. The researcher's understanding will, naturally, be subjective too. However, it will act as a better developed and more informed outsider view, when considering the picture painted by participants and previous studies, thus enabling the researcher to introduce more nuance when analysing data. We introduce this approach after examining what we call the context detachment problem, whereby some bioethics scholarship-empirical or otherwise-fails to reflect the reality of the healthcare setting it concerns. Our proposed ethno-immersion (which differs from formal ethnography) is then explored as a response, highlighting its benefits, and answering the question of timing within a research project. Finally, we reflect on the applicability of our proposal to non-empirical bioethics scholarship, concluding that it remains important but may require some adjustments.

Another "turn" in bioethics? A plea for methodological continuity.

A growing trend in bioethics highlights the importance of using big data science methods to advance normative insight. This has been called the "digital turn" in bioethics by Salloch and Ursin. Automated data processing can, for example, detect significant patterns of correlation that have escaped the attention of human scholars. Although we agree that such technological innovations could bolster existing methods in empirical bioethics (EB), we argue that it should not be conceptualized as a new turn but rather as a revivification, and possibly an amplification of entrenched debates in EB. We begin by highlighting some convergences between EB and digital bioethics that Salloch and Ursin seem to categorize as fundamental differences and end up with elaborating on some risks related to the integration of empirical findings with normative (philosophical) analysis in the digitalization trend.

Moral Distress: What Are We Measuring?

While various definitions of moral distress have been proposed, some agreement exists that it results from illegitimate constraints in clinical practice affecting healthcare professionals' moral agency. If we are to reduce moral distress, instruments measuring it should provide relevant information about such illegitimate constraints. Unfortunately, existing instruments fail to do so. We discuss here several shortcomings of major instruments in use: their inability to determine whether reports of moral distress involve an accurate assessment of the requisite clinical and logistical facts in play, whether the distress in question is aptly characterized as moral, and whether the moral distress reported is an appropriate target of elimination. Such failures seriously limit the ability of empirical work on moral distress to foster appropriate change.

Patient-led innovation and global health justice: Open-source digital health technology for type 1 diabetes care.

Health innovation is mainly envisioned in direct connection to medical research institutions or pharmaceutical and technology companies. Yet, these types of innovation often do not meet the needs and expectations of individuals affected by health conditions. With the emergence of digital health technologies and social media, we can observe a shift, which involves people living with illness modifying and improving medical and health devices outside of the formal research and development sector, figuring both as users and innovators. This patient-led innovation has been celebrated in innovation studies and economics as a "bottom-up" type of innovation. In this article, we take a closer look at open-source patient-led innovation in the context of type 1 diabetes care. In our inquiry, we pay particular attention to the social and ethical dimensions of this innovation, building on empirical material. Upon exploring the notion of patient-led innovation and its socio-political context through the lens of intersectional and global health justice, we argue that a proactive strategy is needed to ensure that open-source patient-led innovation will be more globally accessible, center the health needs of the most underserved populations, as well as facilitate equitable and just health benefits. To support this aim, we provide a range of examples of different initiatives addressing the persistent inequalities that have so far inhibited patient-led innovation from more fully materializing its innovative potential.

The birth of the "digital turn" in bioethics?

The so-called "empirical turn" in bioethics gave rise to extensive theoretical and methodological debates and has significantly shaped the research landscape from two decades ago until the present day. Attentive observers of the evolution of the bioethical research field now notice a new trend towards the inclusion of data science methods for the treatment of ethical research questions. This new research domain of "digital bioethics" encompasses both studies replacing (or complementing) socio-empirical research on bioethical topics ("empirical digital bioethics") and argumentative approaches towards normative questions in the healthcare domain ("argumentative digital bioethics"). This article draws on insights taken from the debate on the "empirical turn" for sounding out perspectives for the newly developing field of "digital bioethics." We particularly discuss the disciplinary boundaries, chances and challenges, and potentially undesirable developments of the research field. The article closes with concrete suggestions on which debates need to be initiated and which measures need to be taken so that the path forward of "digital bioethics" will be a scientific success.

Empirical studies on how ethical recommendations are translated into practice: a cross-section study on scope and study objectives.

BACKGROUND: Empirical research can become relevant for bioethics in at least two ways. First, by informing the development or refinement of ethical recommendations. Second, by evaluating how ethical recommendations are translated into practice. This study aims to investigate the scope and objectives of empirical studies evaluating how ethical recommendations are translated into practice. METHODS: A sample of the latest 400 publications from four bioethics journals was created and screened. All publications were included if they met one of the following three criteria: (1) evaluative empirical research, (2) non-evaluative empirical research and (3) borderline cases. For all publications categorized as evaluative empirical research we analyzed which objects (norms and recommendations) had been evaluated. RESULTS: 234 studies were included of which 54% (n = 126) were categorized as non-evaluative empirical studies, 36% (n = 84) as evaluative empirical studies, and 10% (n = 24) as borderline cases. The object of evaluation were aspirational norms in 5 of the 84 included evaluative empirical studies, more specific norms in 14 (16%) studies and concrete best practices in 65 (77%) studies. The specific best practices can be grouped under five broader categories: ethical procedures, ethical institutions, clinical or research practices, educational programs, and legal regulations. CONCLUSIONS: This mapping study shows that empirical evaluative studies can be found at all stages in the translational process from theory to best practices. Our study suggests two intertwined dimensions for structuring the field of evaluative/translational empirical studies in bioethics: First, three broader categories of evaluation objects and second five categories for types of best practices. TRIAL REGISTRATION: The methodology used was described in a study protocol that was registered publicly on the Open Science Framework ( https://osf.io/r6h4y/ ).

Scientists' Views on the Ethics, Promises and Practices of Synthetic Biology: A Qualitative Study of Australian Scientific Practice.

Synthetic biology is a broad term covering multiple scientific methodologies, technologies, and practices. Pairing biology with engineering, synbio seeks to design and build biological systems, either through improving living cells by adding in new functions, or creating new structures by combining natural and synthetic components. As with all new technologies, synthetic biology raises a number of ethical considerations. In order to understand what these issues might be, and how they relate to those covered in ethics literature on synbio, we conducted an interview study with practicing synthetic biologists affiliated with a synthetic biology centre in Australia. Scientists identified a range of ethical challenges germane to the field, including precarious employment, pressures from industry, gender inequity, and the negative effects of the hyping of synbio. These challenges differed markedly from those identified in the ethics literature, whose treatment of the harms and benefits of synbio remains largely speculative and abstract. In our discussion of the pragmatic, every day ethical issues synthetic biologists face, we illustrate how issues of waste or research integrity play pivotal roles in everything from lived experiences in the laboratory, to long-term research trajectories guiding the field. In a confirmation of the ethical relevance of our participant's views on the field, we argue that the subjects they raise must be included in any ethical analysis of synbio as a field.

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

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

In defence of the bioethics scoping review: Largely systematic literature reviewing with broad utility.

There is growing interest in the possible role of systematic methods of reviewing literature in bioethics. This has arisen alongside the growth of empirical bioethics and a general push towards introducing some level of rigour and reproducibility into scholarship in the field. However, there remain a range of approaches to reviewing literature utilized in bioethics, which vary significantly in their 'systematicness' and suitability for different purposes. In this article, we first detail a taxonomy of various existing reviews used in bioethics and how scholars have defended and critiqued them, presenting them relationally along axes of 'systematic' and 'critical'. Considering the suitability of these reviews, we then explore the inherent differences between normative and empirical literature in relation to how they can be reviewed. In particular, we highlight the challenges in reviewing both normative and empirical literature in a single review. As something of an answer to these challenges, we introduce and defend the scoping review as, in many ways, a method of reviewing literature with wide-ranging utility in bioethics. Demonstrating the many benefits of the scoping review, we then position it within the existing taxonomy of reviews, ultimately arguing that its combination of systematic and critical, inclusive of a reasonable degree of flexibility, makes it deserving of increased attention and use in bioethics.

Research, education, ethics consultation: evaluating a Bioethics Unit in an Oncological Research Hospital.

BACKGROUND: This study aims to quantitatively and qualitatively evaluate the activities of a Bioethics Unit (BU) 5 years since its implementation (2016-2020). The BU is a research unit providing empirical research on ethical issues related to clinical practice, clinical ethics consultation, and ethical education for health care professionals (HPS). METHODS: We performed an explanatory, sequential, mixed-method, observational study, using the subsequent qualitative data to explain the initial quantitative findings. Quantitative data were collected from an internal database and analyzed by descriptive analysis. Qualitative evaluation was performed by semi-structured interviews with 18 HPs who were differently involved in the BU's activities and analyzed by framework analysis. RESULTS: Quantitative results showed an extensive increment of the number of BU research projects over the years and the number of work collaborations with other units and wards. Qualitative findings revealed four main themes, concerning: 1. the reasons for contacting the BU and the type of collaboration; 2. the role of the bioethicist; 3. the impact of BU activities on HPs, in terms of developing deeper and more mature thinking; 4. the need to extend ethics support to other settings. Overall, our results showed that performing both empirical bioethics research and more traditional clinical ethics activities at the same unit would produce an impetus to increase collaboration and spread an 'ethical culture' among local HPs. CONCLUSIONS: Our findings contribute to a growing body of literature on the models of clinical ethics support services and the role of empirical research in bioethics internationally. They also prepare the ground for the implementation of a multidisciplinary Clinical Ethics Committee (CEC) that aims to support the BU's ethics consultation service within the local context.

Acceptable objectives of empirical research in bioethics: a qualitative exploration of researchers' views.

BACKGROUND: This is the first qualitative study to investigate how researchers, who do empirical work in bioethics, relate to objectives of empirical research in bioethics (ERiB). We explore reasons that make some objectives more acceptable, while others are deemed less acceptable. METHODS: Using qualitative exploratory study design, we interviewed bioethics researchers, who were selected to represent different types of scholars working in the field. The interview data of 25 participants were analyzed in this paper using thematic analysis. RESULTS: From the eight objectives presented to the study participants, understanding the context of a bioethical issue and identifying ethical issues in practice received unanimous agreement. Participants also supported other objectives of ERiB but with varying degrees of agreement. The most contested objectives were striving to draw normative recommendations and developing and justifying moral principles. The is-ought gap was not considered an obstacle to ERiB, but rather a warning sign to critically reflect on the normative implications of empirical results. CONCLUSIONS: Our results show that the most contested objectives are also the more ambitious ones, whereas the least contested ones focus on producing empirical results. The potential of empirical research to be useful for bioethics was mostly based on the reasoning pattern that empirical data can provide a testing ground for elements of normative theory. Even though empirical research can inform many parts of bioethical inquiry, normative expertise is recommended to guide ERiB. The acceptability of ambitious objectives for ERiB boils down to finding firm ground for the integration of empirical facts in normative inquiry.

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

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

Real-world ethics in palliative care: A systematic review of the ethical challenges reported by specialist palliative care practitioners in their clinical practice.

BACKGROUND: Ethical issues arise daily in the delivery of palliative care. Despite much (largely theoretical) literature, evidence from specialist palliative care practitioners about day-to-day ethical challenges has not previously been synthesised. This evidence is crucial to inform education and adequately support staff. AIM: To synthesise the evidence regarding the ethical challenges which specialist palliative care practitioners encounter during clinical practice. DESIGN: Systematic review with narrative synthesis (PROSPERO registration CRD42018105365). Quality was dual-assessed using the Mixed-Methods Appraisal Tool. Tabulation, textural description, concept mapping and thematic synthesis were used to develop and present the narrative. DATA SOURCES: Seven databases (MEDLINE, Philosopher's Index, EMBASE, PsycINFO, LILACS, Web of Science and CINAHL) were searched from inception to December 2019 without language limits. Eligible papers reported original research using inductive methods to describe practitioner-reported ethical challenges. RESULTS: A total of 8074 records were screened. Thirteen studies from nine countries were included. Challenges were organised into six themes: application of ethical principles; delivering clinical care; working with families; engaging with institutional structures and values; navigating societal values and expectations; philosophy of palliative care. Challenges related to specific scenarios/contexts rather than the application of general ethical principles, and occurred at all levels (bedside, institution, society, policy). CONCLUSION: Palliative care practitioners encounter a broad range of contextual ethical challenges, many of which are not represented in palliative care ethics training resources, for example, navigating institutional policies, resource allocation and inter-professional conflict. Findings have implications for supporting ethical practice and training practitioners. The lack of low- and middle- income country data needs addressing.

Design Bioethics: A Theoretical Framework and Argument for Innovation in Bioethics Research.

Empirical research in bioethics has developed rapidly over the past decade, but has largely eschewed the use of technology-driven methodologies. We propose "design bioethics" as an area of conjoined theoretical and methodological innovation in the field, working across bioethics, health sciences and human-centred technological design. We demonstrate the potential of digital tools, particularly purpose-built digital games, to align with theoretical frameworks in bioethics for empirical research, integrating context, narrative and embodiment in moral decision-making. Purpose-built digital tools can engender situated engagement with bioethical questions; can achieve such engagement at scale; and can access groups traditionally under-represented in bioethics research and theory. If developed and used with appropriate rigor, tools motivated by "design bioethics" could offer unique insights into new and familiar normative and empirical issues in the field.

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

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

Developing new ways to listen: the value of narrative approaches in empirical (bio)ethics.

The use of qualitative research in empirical bioethics is becoming increasingly popular, but its implementation comes with several challenges, such as difficulties in aligning moral epistemology and methods. In this paper, we describe some problems that empirical bioethics researchers may face; these problems are related to a tension between the different poles on the spectrum of scientific paradigms, namely a positivist and interpretive stance. We explore the ideas of narrative construction, 'genres' in medicine and dominant discourses in relation to empirical research. We also reflect on the loss of depth and context that may occur with thematic or content analyses of interviews, and discuss the need for transparency about methodologies in empirical bioethics. Drawing on insights from narrative approaches in the social sciences and the clinical-educational discipline of Narrative Medicine, we further clarify these problems and suggest a narrative approach to qualitative interviewing in empirical bioethics that enables researchers to 'listen (and read) in new ways'. We then show how this approach was applied in the first author's research project about euthanasia decision-making. In addition, we stress the important ethical task of scrutinizing methodologies and meta-ethical standpoints, as they inevitably impact empirical outcomes and corresponding ethical judgments. Finally, we raise the question whether a 'diagnostic', rather than a 'problem-solving', mindset could and should be foregrounded in empirical ethics, albeit without losing a commitment to ethics' normative task, and suggest further avenues for theorizing about listening and epistemic (in)justice in relation to empirical (bio)ethics.

Defining ethical challenge(s) in healthcare research: a rapid review.

BACKGROUND: Despite its ubiquity in academic research, the phrase 'ethical challenge(s)' appears to lack an agreed definition. A lack of a definition risks introducing confusion or avoidable bias. Conceptual clarity is a key component of research, both theoretical and empirical. Using a rapid review methodology, we sought to review definitions of 'ethical challenge(s)' and closely related terms as used in current healthcare research literature. METHODS: Rapid review to identify peer-reviewed reports examining 'ethical challenge(s)' in any context, extracting data on definitions of 'ethical challenge(s)' in use, and synonymous use of closely related terms in the general manuscript text. Data were analysed using content analysis. Four databases (MEDLINE, Philosopher's Index, EMBASE, CINAHL) were searched from April 2016 to April 2021. RESULTS: 393 records were screened, with 72 studies eligible and included: 53 empirical studies, 17 structured reviews and 2 review protocols. 12/72 (17%) contained an explicit definition of 'ethical challenge(s), two of which were shared, resulting in 11 unique definitions. Within these 11 definitions, four approaches were identified: definition through concepts; reference to moral conflict, moral uncertainty or difficult choices; definition by participants; and challenges linked to emotional or moral distress. Each definition contained one or more of these approaches, but none contained all four. 68/72 (94%) included studies used terms closely related to synonymously refer to 'ethical challenge(s)' within their manuscript text, with 32 different terms identified and between one and eight different terms mentioned per study. CONCLUSIONS: Only 12/72 studies contained an explicit definition of 'ethical challenge(s)', with significant variety in scope and complexity. This variation risks confusion and biasing data analysis and results, reducing confidence in research findings. Further work on establishing acceptable definitional content is needed to inform future bioethics research.

South African traditional values and beliefs regarding informed consent and limitations of the principle of respect for autonomy in African communities: a cross-cultural qualitative study.

BACKGROUND: The Western-European concept of libertarian rights-based autonomy, which advocates respect for individual rights, may conflict with African cultural values and norms. African communitarian ethics focuses on the interests of the collective whole or community, rather than rugged individualism. Hence collective decision-making processes take precedence over individual autonomy or consent. This apparent conflict may impact informed consent practice during biomedical research in African communities and may hinder ethical principlism in African bioethics. This study explored African biomedical researchers' perspectives regarding informed consent and potential limitations to the principle of respect for autonomy in African communities. METHODS: We conducted a qualitative study based on in-depth interviews with 12 biomedical researchers, five females and seven males aged 34 to 74 years, currently working at an African university. Interviews lasted 35-40 min each and involved semi-structured open-ended interviews, which allowed participants to offer information about their perceptions and feelings regarding respect for autonomy and informed consent as practised in Africa. Empirical data from the interviews were recorded, transcribed, and analysed using thematic content analysis, together with an interrogation of relevant scientific literature about African communitarian ethics, making evaluations and drawing inferences consistent with the empirical bioethics approach. RESULTS: Based on these interviews and analysis of relevant literature, we found that informed consent is difficult to apply in an African context because it derives from a Western conception of libertarian rights-based autonomy. Most respondents pointed out that it was challenging to implement informed consent in the African setting. Furthermore, communalism, customary beliefs, spirituality, and relational autonomy are predominant in most African communities, as exemplified by the African moral philosophies of Ubuntu/Botho and Ukama, which emphasize communitarianism over individual rights. We also found that language, education, poverty, and cultural beliefs are barriers to obtaining proper informed consent in African communities. CONCLUSIONS: We conclude that there are limitations to applying the principle of respect for autonomy and informed consent in African communities, especially in the context of human biomedical research. We recommend using a more relational approach, such as Ross's prima facie duties, to implement informed consent in African communities.

Empirical research in clinical ethics: The 'committed researcher' approach.

After the 'empirical turn' in bioethics, few specific approaches have been developed for doing clinical ethics research in close connection with clinical decision-making on a daily basis. In this paper we describe the 'committed researcher' approach to research in clinical ethics that we have developed over the years. After comparing it to two similar research methodological approaches, the 'embedded researcher' and 'deliberative engagement', we highlight its main features: it is patient-oriented, it is implemented by collegial and multidisciplinary teams, it uses an ethical grid to build the interview guide, and it is geared towards bringing the results to bear on the public debate surrounding the issue at stake. Finally, we position our methodological approach with respect to the 'is vs. ought' distinction. We argue that our 'commitment researcher' approach to clinical ethics research takes concerned people's life-building values as the main data, and compares them to the larger normative framework underlying the medical practice at stake.

Assessing Public Opinion on CRISPR-Cas9: Combining Crowdsourcing and Deep Learning.

BACKGROUND: The discovery of the CRISPR-Cas9-based gene editing method has opened unprecedented new potential for biological and medical engineering, sparking a growing public debate on both the potential and dangers of CRISPR applications. Given the speed of technology development and the almost instantaneous global spread of news, it is important to follow evolving debates without much delay and in sufficient detail, as certain events may have a major long-term impact on public opinion and later influence policy decisions. OBJECTIVE: Social media networks such as Twitter have shown to be major drivers of news dissemination and public discourse. They provide a vast amount of semistructured data in almost real-time and give direct access to the content of the conversations. We can now mine and analyze such data quickly because of recent developments in machine learning and natural language processing. METHODS: Here, we used Bidirectional Encoder Representations from Transformers (BERT), an attention-based transformer model, in combination with statistical methods to analyze the entirety of all tweets ever published on CRISPR since the publication of the first gene editing application in 2013. RESULTS: We show that the mean sentiment of tweets was initially very positive, but began to decrease over time, and that this decline was driven by rare peaks of strong negative sentiments. Due to the high temporal resolution of the data, we were able to associate these peaks with specific events and to observe how trending topics changed over time. CONCLUSIONS: Overall, this type of analysis can provide valuable and complementary insights into ongoing public debates, extending the traditional empirical bioethics toolset.