In line with recent proposals for experimental philosophy and philosophy of science in practice, we propose that the philosophy of medicine could benefit from incorporating empirical research, just as bioethics has. In this paper, we therefore take first steps towards the development of an empirical philosophy of medicine, that includes investigating practical and moral dimensions. This qualitative study gives insight into the views and experiences of a group of various medical professionals and patient representatives regarding the conceptualization of health and (...) disease concepts in practice and the possible problems that surround them. This includes clinical, epistemological, and ethical issues. We have conducted qualitative interviews with a broad range of participants (n = 17), working in various health-related disciplines, fields and organizations. From the interviews, we highlight several different practical functions of definitions of health and disease. Furthermore, we discuss 5 types of problematic situations that emerged from the interviews and analyze the underlying conceptual issues. By providing theoretical frameworks and conceptual tools, and by suggesting conceptual changes or adaptations, philosophers might be able to help solve some of these problems. This empirical-philosophical study contributes to a more pragmatic way of understanding the relevance of conceptualizing health and disease by connecting the participants’ views and experiences to the theoretical debate. Going back and forth between theory and practice will likely result in a more complex but hopefully also better and more fruitful understanding of health and disease concepts. (shrink)

As early-career neuroethicists, we come to the field of neuroethics at a unique moment: we are well-situated to consider nearly two decades of neuroethics scholarship and identify challenges that have persisted across time. But we are also looking squarely ahead, embarking on the next generation of exciting and productive neuroethics scholarship. In this article, we both reflect backwards and turn our gaze forward. First, we highlight criticisms of neuroethics, both from scholars within the field and outside it, that have focused (...) on speculation and lack of skepticism; the dearth of consideration of broader social issues such as justice and equality, both with regard to who speaks for neuroethics as a field and who benefits from its recommendations and findings; and the insufficient focus on the practical impact of our ethical work. Second, we embrace the concept of “translational neuroethics” to outline a vision for neuroethics that is integrated, inclusive, and impactful. Integration can help us identify more pertinent, real-world issues, and move away from speculation; inclusivity can help ensure that the questions we attend to are not merely relevant to a single subgroup but aim toward just distribution of benefits; and impact can help us think beyond guidelines and recommendations to focus on implementation. Our goal is for this call to action to help shape neuroethics into a discipline that develops rigorous research agendas through relationships with interdisciplinary partners, that is broadly inclusive and attends to issues beyond novel neurotechnologies, and that is devoted to the translation of scholarship into practice. (shrink)

BackgroundThis 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.MethodsUsing 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. ResultsFrom 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.ConclusionsOur 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. (shrink)

Increasingly, transgender minors are seeking medical care such as puberty-suppressing or gender-affirming hormone therapies. Yet, whether these interventions should be performed at all is highly controversial. Some healthcare practitioners oppose irreversible interventions, considering it their duty to protect children from harm. Others view minors, like adults, as transgender individuals who must be protected from discrimination. The underlying ethical question is presented as a problem of priority. Is it primarily relevant that minors are involved? Or should decision makers focus on the (...) fact that they treat transgender individuals? The paper explores the relevance for medical practice. We provide results of an interview study with German healthcare professionals. We discuss the general question whether prioritization among different group memberships of the same person is ethically defensible. We conclude that priority conflicts between group memberships of the same person can be deceptive and should be addressed by an intersectional approach. Eventually, we discuss practical implications. (shrink)

Background: As a normative theory, care ethics has become widely theorized and accepted. However, there remains a lack of clarity in relation to its use in practice, and a care ethics framework for practice. Maternity care is fraught with ethical issues and care ethics may provide an avenue to enhance ethical sensitivity. Aim: The purpose of this scoping review is to determine how care ethics is used amongst health professions, and to collate the information in data charts to create a (...) care ethics framework and definition for midwifery practice. Method: The scoping review was conducted according to the Preferred Reporting Items for Scoping reviews (PRISMA-ScR) and Joanna Briggs Institute (JBI) recommendations. The search was applied to the databases CINAHL, MEDLINE, PschInfo and Pubmed which were searched in September 2019 and again in July 2021. The inclusion criteria were guided by the mnemonic for search terms: Participants, Concept, and Context (PCC) and included variations of health care professionals, care ethics and utilization. The search was limited to qualitative studies published in English between 2010 and 2021. A data extraction tool was used to extract and synthesize data into categories. The articles were screened for eligibility by title, abstract and full text review, by two independent reviewers. Ethical Considerations: The scoping review was guided by ethical conduct respecting authorship and referencing sources. Results: Twelve of the initially identified 129 studies were included in the scoping review. Data synthesis yielded four categories of care ethics use by health professionals: relationship, context, attention to power and caring practices. In combination, the evidence forms a framework for care ethics use in midwifery practice. Conclusion: Care ethics use by health professionals enhances ethical sensitivity. A framework and definition for care ethics for midwifery practice is proposed. This review will be of interest to midwives and other health practitioners seeking to enhance ethical sensitivity. (shrink)

Empirical moral psychology is sometimes dismissed as normatively insignificant because it plays no decisive role in settling ethical disputes. But that conclusion, even if it is valid for normative ethics, does not extend to bioethics. First, in contrast to normative ethics, bioethics can legitimately proceed from a presupposed moral framework. Within that framework, moral psychology can be shown to play four significant roles: it can improve bioethicists’ understanding of the decision situation, the origin and legitimacy of their moral concepts, efficient (...) options for implementing decisions, and how to change and improve some parts of their moral framework. Second, metaethical considerations suggest that moral psychology may lead to the radical revision of entire moral frameworks and thus prompt the radical revision of entire moral frameworks in bioethics. However, I show that bioethics must either relinquish these radical implications of moral psychology and accept that there are limits to progress in bioethics based on moral psychology or establish an epistemic framework that guides radical revision. (shrink)

The concepts of disease, illness and sickness capture fundamentally different aspects of phenomena related to human ailments and healthcare. The philosophy and theory of medicine are making manifold efforts to capture the essence and normative implications of these concepts. In parallel, socio-empirical studies on patients’ understanding of their situation have yielded a comprehensive body of knowledge regarding subjective perspectives on health-related statuses. Although both scientific fields provide varied valuable insights, they have not been strongly linked to each other. Therefore, the (...) article aims to scrutinise the normative-ethical implications of patient perspectives in building a bridge to the empirical ethics debates. Three potential fields of tension between the illness and the disease perspective are presented. Consequently, findings from empirical research examining patient perspectives on illness are displayed and the practical implications and associated ethical issues which arise are discussed. This leads to the conclusion that an explicit and elaborate empirical-ethical methodology is needed to deal appropriately with the complex interaction between patients’ views and the medico-professional view of disease. Kon’s four-stage model of normative-empirical collaboration is then applied against the background of empirical data on patient perceptions. Starting from this exemplary approach, the article suggests employing empirical-ethical frameworks for further research on the conceptual and normative issues, as they help to integrate perspectives from the philosophy of medicine with socio-empirical research. The combination of theoretical and empirical perspectives suggested contributes to a more nuanced discussion of the normative impact of patients’ actual understanding of illness. Further empirical research in this area would profit from explicitly considering potential ethical issues to avoid naturalistic fallacies or crypto-normative conclusions that may compromise healthcare practice. Vice versa, medico-theoretical debates could be enriched by integrating subjective views of those people who are immediately affected. (shrink)

The theory of evolution of complex and comprising of human systems and algorithm for its constructing are the synthesis of evolutionary epistemology, philosophical anthropology and concrete scientific empirical basis in modern (transdisciplinary) science. «Trans-disciplinary» in the context is interpreted as a completely new epistemological situation, which is fraught with the initiation of a civilizational crisis. Philosophy and ideology of technogenic civilization is based on the possibility of unambiguous demarcation of public value and descriptive scientific discourses (1), and the object and (...) subject of the cognitive process (2). Both of these attributes are no longer valid. For mass, everyday consciousness and institutional philosophical tradition it is intuitively obvious that having the ability to control the evolutionary process, Homo sapiens came close to the borders of their own biological and cultural identity. The spontaneous coevolutionary process of interaction between the «subject» (rational living organisms) and the «object» (material world), is the teleological trend of the movement towards the complete rationalization of the World as It Is, its merger with the World of Due. The stratification of the global evolutionary process into selective and semantic (teleological) coevolutionary and therefore ontologically inseparable components follows. With the entry of anthropogenic civilization into the stage of the information society, firsty, the post-academic phase of the historical evolution of scientific rationality began, the attributes of which are the specific methodology of scientific knowledge, scientific ethos and ontology. Bioethics as a phenomenon of intellectual culture represents a natural philosophical core of modern post- academic (human-dimensional) science, in which the ethical neutrality of scientific theory principle is inapplicable, and elements of public-axiological and scientific-descriptive discourses are integrated into a single logic construction. As result, hermeneutics precedes epistemology not only methodologically, but also meaningfully, and natural philosophy is regaining the status of the backbone of the theory of evolution – in an explicit form. (shrink)

Research in the field of Empirical Ethics (EE) uses a broad variety of empirical methodologies, such as surveys, interviews and observation, developed in disciplines such as sociology, anthropology, and psychology. Whereas these empirical disciplines see themselves as purely descriptive, EE also aims at normative reflection. Currently there is literature about the quality of empirical research in ethics, but little or no reflection on specific methodological aspects that must be considered when conducting interdisciplinary empirical ethics. Furthermore, poor methodology in an EE (...) study results in misleading ethical analyses, evaluations or recommendations. This not only deprives the study of scientific and social value, but also risks ethical misjudgement. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 41-42, June 2011.

Community treatment orders are a legal mechanism to extend powers of compulsion into outpatient mental health settings in certain circumstances. Previous ethical analyses of these powers have explored a perceived tension between a duty to respect personal freedoms and autonomy and a duty to ensure that patients with the most complex needs are able to receive beneficial care and support that maximises their welfare in the longer-term. This empirical ethics paper presents an analysis of 75 interviews with psychiatrists, patients and (...) family carers to show how these ethical considerations map onto the different ways that community treatment orders are used and experienced in practice. A complex and nuanced account of how the requirements to respect patients’ autonomy, to respect patients’ liberty and to act beneficently should be interpreted in order to make judgements about the ethics of community treatment orders is presented. The article argues that, due to such complexity, no general ethical justification for community treatment orders can be provided, but a justification on the basis of the promotion of patients’ autonomy could provide an ethical reason for community mental health practitioners to make use of a community treatment order in some limited circumstances. (shrink)

Zusammenfassung Hintergrund Stigmatisierung hat einen erheblichen Einfluss auf die Gesundheit verschiedener gesellschaftlicher Gruppen und trägt zu Ungleichheiten im Gesundheitswesen bei. Sexarbeit ist mit erheblichem sozialem Stigma verbunden, das sich nachteilig auf den Zugang von Sexarbeiter*innen zur Gesundheitsversorgung auswirkt. Die vorliegende explorative Studie gibt erste Einblicke in die Sichtweisen von Sexarbeiter*innen und Berater*innen in Deutschland auf den Zugang, die Bedürfnisse und die Barrieren von Sexarbeiter*innen in Bezug auf die Gesundheitsversorgung. Dabei lag der Fokus auf einem etablierten Netzwerk von Gesundheitsangeboten für Sexarbeiter*innen (...) in Bochum. Methoden Leitfadengestützte Interviews wurden mit 4 Berater*innen durchgeführt, die soziale und medizinische Beratung für Sexarbeiter*innen anbieten, sowie mit 3 Sexarbeiter*innen, die diese Angebote nutzen. Die Interviews wurden mittels qualitativer Inhaltsanalyse nach Kuckartz ausgewertet. Ergebnisse Es zeigten sich verschiedene Hürden bei der Inanspruchnahme von Gesundheitsversorgung, insbesondere aufgrund unzureichender Krankenversicherung oder fehlendem Wissen über den eigenen Krankenversicherungsstatus, Sprachbarrieren, Bürokratie, Mobilität und Diskriminierung in der Gesundheitsversorgung. Diskriminierung aufgrund von Sexarbeit überschnitt sich mit anderen Diskriminierungsformen, wie beispielsweise antislawischem Rassismus oder der Stigmatisierung von Schwangerschaftsabbrüchen. Spezifische Bedürfnisse und Barrieren wurden hinsichtlich psychischer Gesundheit angegeben, die sich als wichtiges Thema für Sexarbeiter*innen erwies. Die bestehenden kostenlosen, anonymen und zugänglichen Angebote für Sexarbeiter*innen, insbesondere aufsuchende Angebote, wurden als hilfreich beschrieben. Sexarbeiter*innen und Berater*innen wiesen auf einen Mangel an Angeboten für unterschiedliche Bedürfnisse von Sexarbeiter*innen hin, die über Tests auf sexuell übertragbare Infektionen und deren Behandlung hinausgehen, z. B. im Bereich der psychischen Gesundheit. Schlussfolgerung Nach wie vor bestehen Barrieren für den Zugang zur Gesundheitsversorgung, von denen viele besonders Sexarbeiter*innen mit Migrationsgeschichten aus osteuropäischen Ländern betreffen. Die Studie zeigt, dass die Etablierung antidiskriminierender Gesundheitsangebote für Sexarbeiter*innen notwendig ist. Bei der Entwicklung solcher Angebote sollten die Perspektiven von Sexarbeiter*innen eine zentrale Rolle einnehmen. (shrink)

Developments in medical big data analytics may bring societal benefits but are also challenging privacy and other ethical values. At the same time, an overly restrictive data protection regime can form a serious threat to valuable observational studies. Discussions about whether data privacy or data solidarity should be the foundational value of research policies, have remained unresolved. We add to this debate with an empirically informed ethical analysis. First, experiences with the implementation of the General Data Protection Regulation (GDPR) within (...) a European research consortium demonstrate a gap between the aims of the regulation and its effects in practice. Namely, strictly formalised data protection requirements may cause routinisation among researchers instead of substantive ethical reflection, and may crowd out trust between actors in the health data research ecosystem; while harmonisation across Europe and data sharing between countries is hampered by different interpretations of the law, which partly stem from different views about ethical values. Then, building on these observations, we use theory to argue that the concept of trust provides an escape from the privacy-solidarity debate. Lastly, the paper details three aspects of trust that can help to create a responsible research environment and to mitigate the encountered challenges: trust as multi-agent concept; trust as a rational and democratic value; and trust as method for priority setting. Mutual cooperation in research—among researchers and with data subjects—is grounded in trust, which should be more explicitly recognised in the governance of health data research. (shrink)

Background Over the last decades, the neurosciences, behavioral sciences, and the social sciences have all seen a rapid development of innovative research methods. The field of bioethics, however, has trailed behind in methodological innovation. Despite the so-called “empirical turn” in bioethics, research methodology for project development, data collection and analysis, and dissemination has remained largely restricted to surveys, interviews, and research papers. We have previously argued for a “Design Bioethics” approach to empirical bioethics methodology, which develops purpose-built methods for investigation (...) of bioethical concerns. In this paper we compare a research tool created using a design bioethics approach to a “methods-as-usual” approach in empirical bioethics. Methods Our study compared dimensions of engagement with a digital game we created, called “Tracing Tomorrow,” to a standard vignette survey. The two tools investigated the same subject matter, digital phenotyping for mental health, in a sample of 301 UK adolescents. Results Participants who played the game reported a greater sense of presence, emotional engagement, cognitive absorption, and mental health ethics insight, compared to participants who completed the vignette survey. Perceived authenticity and curiosity/motivation to learn more was equivalent for both methods. Conclusion The results of this study highlights the importance of purpose-built methodology for empirical bioethics research. (shrink)

The online space has become a digital public square, where individuals interact and share ideas on the most trivial to the most serious of matters, including discussions of controversial ethical issues in science, technology and medicine. In the last decade, new disciplines like computational social science and social data science have created methods to collect and analyse such data that have considerably expanded the scope of social science research. Empirical bioethics can benefit from the integration of such digital methods to (...) investigate novel digital phenomena and trace how bioethical issues take shape online.Here, using concrete examples, we demonstrate how novel methods based on digital approaches in the social sciences can be used effectively in the domain of bioethics. We show that a digital turn in bioethics research aligns with the established aims of empirical bioethics, integrating with normative analysis and expanding the scope of the discipline, thus offering ways to reinforce the capacity of bioethics to tackle the increasing complexity of present-day ethical issues in science and technology. We propose to call this domain of research in bioethicsdigital bioethics. (shrink)

Applied ethics is home to numerous productive subfields such as procreative ethics, intergenerational ethics and environmental ethics. By contrast, there is far less ethical work on ageing, and there is no boundary work that attempts to set the scope for ‘ageing ethics’ or the ‘ethics of ageing’. Yet ageing is a fundamental aspect of life; arguably even more fundamental and ubiquitous than procreation. To remedy this situation, I examine conceptions of what the ethics of ageing might mean and argue that (...) these conceptions fail to capture the requirements of the desired subfield. The key reasons for this are, first, that they view ageing as something that happens only when one is old, thereby ignoring the fact that ageing is a process to which we are all subject, and second that the ageing person is treated as an object in ethical discourse rather than as its subject. In response to these shortcomings I put forward a better conception, one which places the ageing person at the centre of ethical analysis, has relevance not just for the elderly and provides a rich yet workable scope. While clarifying and justifying the conceptual boundaries of the subfield, the proposed scope pleasingly broadens the ethics of ageing beyond common negative associations with ageing. (shrink)

Despite the increased prevalence of bioethics research that seeks to use empirical data to answer normative research questions, there is no consensus as to what an appropriate methodology for this would be. This review aims to search the literature, present and critically discuss published Empirical Bioethics methodologies.

The target article by Alexander Kon (2009) offers an excellent conceptual toolkit to analyze the current literature on empirical bioethics, a topic which has attracted so much attention in the bioe...

This study’s objective was to understand Colombian adolescents’ experiences and preferences regarding access to sexual and reproductive health services (SRHS), either alone or accompanied. A mixed-method approach was used, involving a survey of 812 participants aged eleven to twenty-four years old and forty-five semi-structured interviews with participants aged fourteen to twenty-three. Previous research shows that adolescents prefer privacy when accessing SRHS and often do not want their parents involved. Such findings align with the longstanding tendency to frame the ethical principle (...) of autonomy as based on independence in decision-making. However, the present study shows that such a conceptualization and application of autonomy does not adequately explain Colombian adolescent participants’ preferences regarding access to SRHS. Participants shared a variety of preferences to access SRHS, with the majority of participants attaching great importance to having their parents involved, to varying degrees. What emerges is a more complex and non-homogenous conceptualization of autonomy that is not inherently grounded in independence from parental involvement in access to care. We thus argue that when developing policies involving adolescents, policymakers and health professionals should adopt a nuanced “relational autonomy” approach to better respect the myriad of preferences that Colombian (and other) adolescents may have regarding their access to SRHS. (shrink)

In 2014, the first child in the world was born after live uterus transplantation and IVF (UTx-IVF). Before and after this event, ethical aspects of UTx-IVF have been discussed in the medical and bioethical debate as well as, with varying intensity, in Swedish media and political fora. This article examines what comes to be identified as important ethical problems and solutions in the media debate of UTx-IVF in Sweden, showing specifically how problems, target groups, goals, benefits, risks and stakes are (...) delineated and positioned. It also demonstrates how specific assumptions, norms and values are expressed and used to underpin specific positions within this debate, and how certain subjects, desires and risks become shrouded or simply omitted from it. This approach—which we label the Ethics of the Societal Entrenchment-approach, inspired by Koch and Stemerding (1994)—allows us to discuss how the identification of something as the problem helps to shape what gets to be described as a solution, and how specific solutions provide frameworks within which problems can be stated and emphasised. We also offer a critical discussion of whether some of these articulations and formations should be seen as ethically troubling, and if so, why. (shrink)

Bioethics became applied ethics when it was assimilated to moral philosophy. Because deduction is the rationality of moral philosophy, subsuming facts under moral principles to deduce conclusions about what ought to be done became the prescribed reasoning of bioethics, and bioethics became a theory comprised of moral principles. Bioethicists now realize that applied ethics is too abstract and spare to apprehend the specificity, particularity, complexity and contingency of real moral issues. Empirical ethics and contextual ethics are needed to incorporate these (...) features into morality, not just bioethics. The relevant facts and features of problems have to be identified, investigated and framed coherently, and potential resolutions have to be constructed and assessed. Moreover, these tasks are pursued and melded within manifold contexts, for example, families, work and health care systems, as well as societal, economic, legal and political backgrounds and encompassing worldviews. This naturalist orientation and both empirical ethics and contextual ethics require judgment, but how can judgment be rational? Rationality, fortunately, is more expansive than deductive reasoning. Judgment is rational when it emanates from a rational process of deliberation, and a process of deliberation is rational when it uses the resources of non-formal reason: observation, creative construction, formal and informal reasoning methods and systematic critical assessment. Empirical ethics and contextual ethics recognize that finite, fallible human beings live in complex, dynamic, contingent worlds, and they foster creative, critical deliberation and employ non-formal reason to make rational moral judgments. (shrink)

In the closed wards of mental health institutions, moral decisions are made concerning the use of forced seclusion. In this article we focus on how these moral decisions are made and can be improved. We present a case study concerning moral deliberations on the use of seclusion and its prevention among nurses of a closed mental health ward. Moral psychology provides an explanation of how moral judgments are developed through processes of interaction. We will make use of the Social Intuitionist (...) Model of Jonathan Haidt that emphasizes the role of emotions, intuitions and the social context in moral judgments and reasoning. We argue that this model can help to explain social dynamics in the context of enforced seclusion. In the discussion we explore how moral psychology can be complemented with the normative perspective of dialogical ethics to develop strategies for improving psychiatric practices. We conclude that social processes play an important role in moral deliberations and that moral development can be fostered by bringing in new perspectives in the dialogue. Moral case deliberation provides a practical tool to systematically organize moral reflections among nurses on the work floor. (shrink)

Multiple authorship is becoming increasingly common in bioethics research. There are well-established criteria for authorship in empirical bioethics research but not for conceptual research. It is important to develop criteria for authorship in conceptual publications to prevent undeserved authorship and uphold standards of fairness and accountability. This article explores the issue of multiple authorship in bioethics and develops criteria for determining who should be an author on a conceptual publication in bioethics. Authorship in conceptual research should be based on contributing (...) substantially to: (1) identifying a topic, problem, or issue to study; (2) reviewing and interpreting the relevant literature; (3) formulating, analyzing, and evaluating arguments that support one or more theses; (4) responding to objections and counterarguments; and (5) drafting the manuscript and approving the final version. Authors of conceptual publications should participate substantially in at least two of areas (1)?(5). (shrink)

BackgroundEmpirical 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. MethodsA 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.Results234 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.ConclusionsThis 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/). (shrink)

BackgroundMedical ethics has recently seen a drive away from multiple prescriptive approaches, where physicians are inundated with guidelines and principles, towards alternative, less deontological perspectives. This represents a clear call for theory building that does not produce more guidelines. Phronesis (practical wisdom) offers an alternative approach for ethical decision-making based on an application of accumulated wisdom gained through previous practice dilemmas and decisions experienced by practitioners. Phronesis, as an ‘executive virtue’, offers a way to navigate the practice virtues for any (...) given case to reach a final decision on the way forward. However, very limited empirical data exist to support the theory of phronesis-based medical decision-making, and what does exist tends to focus on individual practitioners rather than practice-based communities of physicians.MethodsThe primary research question was: What does it mean to medical practitioners to make ethically wise decisions for patients and their communities? A three-year ethnographic study explored the practical wisdom of doctors (n = 131) and used their narratives to develop theoretical understanding of the concepts of ethical decision-making. Data collection included narrative interviews and observations with hospital doctors and General Practitioners at all stages in career progression. The analysis draws on neo-Aristotelian, MacIntyrean concepts of practice- based virtue ethics and was supported by an arts-based film production process.ResultsWe found that individually doctors conveyed many different practice virtues and those were consolidated into fifteen virtue continua that convey the participants’ ‘collective practical wisdom’, including the phronesis virtue. This study advances the existing theory and practice on phronesis as a decision-making approach due to the availability of these continua.ConclusionGiven the arguments that doctors feel professionally and personally vulnerable in the context of ethical decision-making, the continua in the form of a video series and app based moral debating resource can support before, during and after decision-making reflection. The potential implications are that these theoretical findings can be used by educators and practitioners as a non-prescriptive alternative to improve ethical decision-making, thereby addressing the call in the literature, and benefit patients and their communities, as well. (shrink)

This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and significance of the concept of (...) ‘integrating’ empirical methods and ethical argument as a standard for research practice within empirical bioethics. (shrink)

This article is concerned with the role empirical research can play in normative practical ethics. There is no doubt that ethical research requires some kind of collaboration between normative disciplines and empirical sciences. But many researchers hold that empirical science is only assigned a subordinate role, due to the doctrine that normative conclusions cannot be justified by descriptive premises. Scientists working in the field of ethics commonly hold, however, that the empirical sciences should play a much bigger role in ethical (...) research. The aim of this paper is to show that empirical sciences can play a substantive role in normative ethics, with no illicit inferences from is to ought. To achieve this aim, I explain Hume’s thesis. In the following sections, I am concerned with different uses of empirical data that do not imply an illicit inference from descriptive premises to a normative conclusion. The article demonstrates that there are many modes of ethical reasoning that allow for a substantive use of empirical data, and it also shows the importance of Hume’s thesis for clarifying ethical reasoning. (shrink)

Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a (...) chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s. (shrink)

This paper aims to provide a description of how authors publishing in medical ethics journals have made use of empirical research data in papers on the topic of gamete or embryo donation by means of references to studies conducted by others. Rather than making a direct contribution to the theoretical methodological literature about the role empirical research data could play or should play in ethics studies, the focus is on the particular uses of these data and the problems that can (...) be encountered with this use. In the selection of papers examined, apart from being used to describe the context, empirical evidence was mainly used to recount problems that needed solving. Few of the authors looked critically at the quality of the studies they quoted, and several instances were found of empirical data being used poorly or inappropriately. This study provides some initial baseline evidence that shows empirical data, in the form of references to studies, are sometimes being used in inappropriate ways. This suggests that medical ethicists should be more concerned about the quality of the empirical data selected, the appropriateness of the choice for a particular type of data and the correct integration of this evidence in sound argumentation. Given that empirical data can be misused also when merely cited instead of reported, it may be worthwhile to explore good practice requirements for this type of use of empirical data in medical ethics. (shrink)

South Africa is a major hub of HIV prevention trials, with plans for a licensure trial to start in 2015. The appropriate standards of care and of prevention in HIV vaccine trials are complex and debated issues and ethical guidelines offer some direction. However, there has been limited empirical exploration of South African stakeholders’ perspectives on ethical guidance related to prevention and care in HIV vaccine trials.

It can be assumed that value judgements, which are needed to judge what is ‘good’ or ‘better’ and what is ‘bad’ or ‘worse’, are involved in every decision-making process. The theoretical understanding and analysis of value judgements is, therefore, important in the context of bioethics, for example, to be able to ethically assess real decision-making processes in biomedical practice and make recommendations for improvements. However, real decision-making processes and the value judgements inherent in them must first be investigated empirically (‘empirical (...) bioethics’). For this to succeed, what exactly a ‘value judgement’ is and of what components it might consist must initially be theoretically clarified. A corresponding conceptual model can then support or even enable empirical data collection and analysis and, above all, subsequent ethical analysis and evaluation. This paper, therefore, presents a value judgement model with its theoretical derivation. It also illustrates its application in an interview study of decision-making between animal experimentation and alternative methods in the context of biomedical research. Though the model itself can be theoretically deepened and extended, the application of the model works in general and helps to uncover what value judgements can enter into decision-making. However, the empirical methods, for example, qualitative interviews, can also be better oriented towards eliciting value judgements (as understood according to the model). Further applications of the model to other topics or by means of other empirical methods are conceivable. (shrink)

While the bioethics literature demonstrates that the field has spent substantial time and thought over the last four decades on the goals, methods, and desired outcomes for service and training in bioethics, there has been less progress defining the nature and goals of bioethics research and scholarship. This gap makes it difficult both to describe the breadth and depth of these areas of bioethics and, importantly, to gauge their success. However, the gap also presents us with an opportunity to define (...) this scope of work for ourselves and to help shape the broader conversation about the impact of academic research. Because of growing constraints on academic funding, researchers and scholars in many fields are being asked to demonstrate and also forecast the value and impact of their work. To do that, and also to satisfy ourselves that our work has meaningful effect, we must understand how our work can motivate change and how that change can be meaningfully measured. In a field as diverse as bioethics, the pathways to and metrics of change will likewise be diverse. It is therefore critical that any assessment of the impact of bioethics research and scholarship be informed by an understanding of the nature of the work, its goals, and how those goals can and ought to be furthered. In this paper, we propose a conceptual model that connects individual bioethics projects to the broader goals of scholarship, describing the translation of research and scholarly output into changes in thinking, practice, and policy. One of the key implications of the model is that impact in bioethics is generally the result of a collection of projects rather than of any single piece of research or scholarship. Our goal is to lay the groundwork for a thoroughgoing conversation about bioethics research and scholarship that will advance and shape the important conversation about their impact. (shrink)

Empirical bioethics is commonly understood as integrating empirical research with normative-ethical research in order to address an ethical issue. Methodological analyses in empirical bioethics mainly focus on the integration of socio-empirical sciences and normative ethics. But while there are numerous multidisciplinary research projects combining life sciences and normative ethics, there is few explicit methodological reflection on how to integrate both fields, or about the goals and rationales of such interdisciplinary cooperation. In this paper we will review some drivers for the (...) tendency of empirical bioethics methodologies to focus on the collaboration of normative ethics with particularly social sciences. Subsequently, we argue that the ends of empirical bioethics, not the empirical methods, are decisive for the question of which empirical disciplines can contribute to empirical bioethics in a meaningful way. Using already existing types of research integration as a springboard, five possible types of research which encompass life sciences and normative analysis will illustrate how such cooperation can be conceptualized from a methodological perspective within empirical bioethics. We will conclude with a reflection on the limitations and challenges of empirical bioethics research that integrates life sciences. (shrink)

BackgroundVerbal autopsy is a pragmatic approach for generating cause-of-death data in contexts without well-functioning civil registration and vital statistics systems. It has primarily been conducted in health and demographic surveillance systems (HDSS) in Africa and Asia. Although significant resources have been invested to develop the technical aspects of verbal autopsy, ethical issues have received little attention. We explored the benefits and burdens of verbal autopsy in HDSS settings and identified potential strategies to respond to the ethical issues identified.MethodsThis research was (...) based on a case study approach centred on two contrasting HDSS in Kenya and followed the Mapping-Framing-Shaping Framework for empirical bioethics research. Data were collected through individual interviews, focus group discussions, document reviews and non-participant observations. 115 participants were involved, including 86 community members (HDSS residents and community representatives), and 29 research staff (HDSS managers, researchers, census field workers and verbal autopsy interviewers).ResultsThe use of verbal autopsy data for research and public health was described as the most common potential benefit of verbal autopsy in HDSS. Community members mentioned the potential uses of verbal autopsy data in addressing immediate public health problems for the local population while research staff emphasized the benefits of verbal autopsy to research and the wider public. The most prominent burden associated with the verbal autopsy was emotional distress for verbal autopsy interviewers and respondents. Moral events linked to the interview, such as being unsure of the right thing to do (moral uncertainty) or knowing the right thing to do and being constrained from acting (moral constraint), emerged as key causes of emotional distress for verbal autopsy interviewers.ConclusionsThe collection of cause-of-death data through verbal autopsy in HDSS settings presents important ethical and emotional challenges for verbal autopsy interviewers and respondents. These challenges include emotional distress for respondents and moral distress for interviewers. This empirical ethics study provides detailed accounts of the distress caused by verbal autopsy and highlights ethical tensions between potential population benefits and risks to individuals. It includes recommendations for policy and practice to address emotional and moral distress in verbal autopsy. (shrink)

BackgroundThere is general consensus internationally that unfair distribution of the benefits of research is exploitative and should be avoided or reduced. However, what constitutes fair benefits, and the exact nature of the benefits and their mode of provision can be strongly contested. Empirical studies have the potential to contribute viewpoints and experiences to debates and guidelines, but few have been conducted. We conducted a study to support the development of guidelines on benefits and payments for studies conducted by the KEMRI-Wellcome (...) Trust programme in Kilifi, Kenya.MethodsFollowing an initial broad based survey of cash, health services and other items being offered during research by all programme studies (n = 38 studies), interviews were held with research managers (n = 9), and with research staff involved in 8 purposively selected case studies (n = 30 interviewees). Interviews explored how these ‘benefits’ were selected and communicated, experiences with their administration, and recommendations for future guidelines. Data fed into a consultative workshop attended by 48 research staff and health managers, which was facilitated by an external ethicist.FindingsThe most commonly provided benefits were medical care (for example free care, and strengthened quality of care), and lunch or snacks. Most cash given to participants was reimbursement of transport costs (for example to meet appointments or facilitate use of services when unexpectedly sick), but these payments were often described by research participants as benefits. Challenges included: tensions within households and communities resulting from lack of clarity and agreement on who is eligible for benefits; suspicion regarding motivation for their provision; and confusion caused by differences between studies in types and levels of benefits.ConclusionsResearch staff differed in their views on how benefits should be approached. Echoing elements of international benefit sharing and ancillary care debates, some research staff saw research as based on goodwill and partnership, and aimed to avoid costs to participants and a commercial relationship; while others sought to maximise participant benefits given the relative wealth of the institution and the multiple community needs. An emerging middle position was to strengthen collateral or indirect medical benefits to communities through collaborations with the Ministry of Health to support sustainability. (shrink)

Clinical neuroethics and neuroskepticism are recent entrants to the vocabulary of neuroethics. Clinical neuroethics has been used to distinguish problems of clinical relevance arising from developments in brain science from problems arising in neuroscience research proper. Neuroskepticism has been proposed as a counterweight to claims about the value and likely implications of developments in neuroscience. These two emergent streams of thought intersect within the practice of neurology. Neurologists face many traditional problems in bioethics, like end of life care in the (...) persistent vegetative state, determination of capacity in progressive dementia, and requests for assisted suicide in cognition-preserving neurodegenerative disease (like amyotrophic lateral sclerosis). Neurologists also look to be at the forefront of downstream clinical applications of neuroscience, like pharmacological enhancement of mental life. At the same time, the practice of neurology, concerned primarily with the structure, function, and treatment of the nervous system, has historically fostered a kind of skeptical attitude toward its own subject matter. Not all problems that appear primarily neurological are primarily neurological. This disciplinary skepticism is generally clinical in orientation and limited in scope. The rise of interest in clinical neuroethics and in neuroskepticsim generally suggests a possible broader application. The clinical skepticism of neurology provides impetus for thinking about the appropriate role for skepticism in clinical areas of neuroethics. After a brief review of neuroskepticism and clinical neuroethics, a taxonomy of clinical neuroskepticism is offered and reasons why a stronger rather than weaker form of clinical neuroskepticism is currently warranted. (shrink)

(2010). Ethical Rules for Human Subjects Research: A Case Where the “Is” Must Inform the “Ought”. The American Journal of Bioethics: Vol. 10, No. 6, pp. 14-15.

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. (shrink)

The use of empirical research methods in bioethics has been increasing in the last decades. It has resulted in discussions about the ‘empirical turn of bioethics’ and raised questions related to the value of empirical work for this field, methodological questions about its quality and rigor, and how this integration of the normative and the empirical can be achieved. The aim of this paper is to describe the attitudes of bioethics researchers in this field towards the use of empirical research, (...) and examine their actual conduct: whether they use empirical research methods, and whether they have made attempts at integrating the empirical and the normative. An anonymous online survey was conducted to reach scholars working in bioethics/biomedical ethics/ethics institutes or centers in 12 European countries. A total of 225 bioethics researchers participated in the study. Of those, 200 questionnaires were fully completed, representing a response rate of 42.6%. The results were analysed using descriptive statistics. Most respondents indicated that they use or have used empirical methods in their work. A similar proportion of respondents reported having had at least some training in qualitative or quantitative methods, respectively. Among the ‘empirical researchers’, more than a fifth had not received any methodological training. It appears that only 6% or less of the ‘empirical researchers’ considered themselves experts in the methods that they have used. Only 35% of the scholars who have used empirical methods reported having integrated empirical data with normative analysis, whereas for their current projects, 59.8% plan to do so. There is a need to evaluate the current educational programs in bioethics and to implement rigorous training in empirical research methods to ensure that ‘empirical researchers’ have the necessary skills to conduct their empirical research in bioethics. Also imperative is clear guidance on the integration of the normative and the empirical so that researchers who plan to do so have necessary tools and competences to fulfil their goals. (shrink)