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.

Background The convergence of neuroscience, genomics, and data science holds promise to unveil the neurobiology of psychosis and to produce new ways of preventing, diagnosing, and treating psychotic illness. Yet, moral challenges arise in neurobiological research and in the clinical translation of research findings. This article investigates the views of relevant actors in mental health on the moral challenges of accessing neurobiological information in the context of psychosis. Methods Semi-structured individual interviews with two groups: researchers employed in the National Health (...) Service (NHS) or a university in England (n = 14), and mental health professionals employed in NHS mental health services (n = 14). This article compares results in the two groups (total n = 28). Results This article presents findings around three conceptual areas: (1) research ethics as mostly unproblematic, (2) psychosis, neurobiological information, and mental health care, and (3) identity, relationships, and the future. These areas are drawn from the themes and topics that emerged in the interviews across the two groups of participants. Researchers and health professionals provided similar accounts of the moral challenges of accessing—which includes acquisition, communication, and use of—neurobiological information in the context of psychosis. Acquiring neurobiological information was perceived as mostly unproblematic, provided ethical safeguards are put in place. Conversely, participants argued that substantive moral challenges arise from how neurobiological information is delivered—that is, communicated and used—in research and in clinical care. Neurobiological information was seen as a powerful tool in the process through which individuals define their identity and establish personal and clinical goals. The pervasiveness of this narrative tool may influence researchers and health professionals’ perception of ethical principles and moral obligations. Conclusions This study suggests that the moral challenges that arise from accessing neurobiological information in the context of psychosis go beyond traditional research and clinical ethics concerns. Reflecting on how accessing neurobiological information can influence individual self-narratives will be vital to ensure the ethical translation of neuroscience and genomics into mental health. Trial registration The study did not involve a health care intervention on human participants. It was retrospectively registered on 11 July 2018, registration number: researchregistry4255. (shrink)

This paper presents a pedagogical framework for teaching cross-cultural clinical ethics. The approach, offered at the intersection of anthropology and bioethics, is innovative in that it takes on the “social sciences versus bioethics” debate that has been ongoing in North America for three decades. The argument is made that this debate is flawed on both sides and, moreover, that the application of cross-cultural thinking to clinical ethics requires using the tools of the social sciences within a principles-based framework for clinical (...) ethics. This paper introduces the curriculum and provides guidelines for how to teach cross-cultural clinical ethics. The learning points that are introduced emphasize culture in its relation to power and underscore the importance of viewing both biomedicine and bioethics as culturally constructed. (shrink)

One of the challenges of modern healthcare ethics practice is the navigation of boundaries. Practicing healthcare ethicists in the performance of their role must navigate meanings, choices, decisions and actions embedded in complex cultural and social relationships amongst diverse individuals. In light of the evolving state of modern healthcare ethics practice and the recent move toward professionalization via certification, understanding boundary navigation in healthcare ethics practice is critical. Because healthcare ethics is endowed with many boundaries which often delineate concerns about (...) professional expertise and authority, epistemological reflection on the relationship between theory and practice points toward the social context as relevant to the conceptualization of boundaries. The skills of social scientists may prove helpful to provide data and insights into the conceptualization and navigation of clinical ethics qua profession. Empirical ethics research, which combines empirical description (usually social scientific) with normative-ethical analysis and reflection, is a way forward as we engage and reflect upon issues which have implications for practice standards and professionalization of the role. This requires cooperative engagement of the descriptive and normative disciplines to explore our understandings of boundaries in healthcare ethics practice. This will contribute to the ongoing reflection not only as we envision the professional role but to ensure that it is enacted in practice. (shrink)

Moral theory is an important guide to bioethical decision-making, but it can confuse and mislead those who offer ethical advice to clinicians and researchers, delaying decisions that must be made in a timely fashion. In this paper I examine the ways moral theory can lead bioethicists astray. Absent a sensitivity to the empirical realities of ethical problems, moral theory 1) contributes to the disappearance of the persons caught in an ethical quandary, 2) focuses on the puzzle-solving rather than examining the (...) conditions that generate moral problems, and 3) universalizes ethical dilemmas, overlooking local processes for resolving moral questions. Taken together, empirically informed moral theory and theoretically informed empirical research can help bioethicists transcend the is/ought problem in ethical work. (shrink)

*Work on this paper was funded in part by NIH grant K01-AT00054, National Center for Complementary and Alternative Medicine. Know then thyself, presume not God to scan The proper study of mankind i...

Anthropologists and sociologists offer numerous critiques of bioethics. Social scientists criticize bioethicists for their arm-chair philosophizing and socially ungrounded pontificating, offering philosophical abstractions in response to particular instances of suffering, making all-encompassing universalistic claims that fail to acknowledge cultural differences, fostering individualism and neglecting the importance of families and communities, and insinuating themselves within the “belly” of biomedicine. Although numerous aspects of bioethics warrant critique and reform, all too frequently social scientists offer ungrounded, exaggerated criticisms of bioethics. Anthropological and sociological (...) critiques of bioethics are hampered by the tendency to equate bioethics with clinical ethics and moral theory in bioethics with principlist bioethics. Also, social scientists neglect the role of bioethicists in addressing organizational ethics and other “macro-social” concerns. If anthropologists and sociologists want to provide informed critiques of bioethics they need to draw upon research methods from their own fields and develop richer, more informed analyses of what bioethicists say and do in particular social settings. (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)

Much has been written in the last decade about how we should understand the value of the sociology of bioethics. Increasingly the value of the sociology of bioethics is interpreted by its advocates directly in terms of its relationship to bioethics. It is claimed that the sociology of bioethics (and related disciplinary approaches) should be seen as an important component of work in bioethics. In this paper we wish to examine whether, and how, the sociology of bioethics can be defended (...) as a valid and justified research activity, in the context of debates about the nature of bioethics. We begin by presenting and arguing for an account of bioethics that does justice to the content of the field, the range of questions that belong within this field, and the justificatory standards (and methodological orientations) that can provide convincing answers to these questions. We then consider the role of sociology in bioethics and show how and under what conditions it can contribute to answering questions within bioethics. In the final section, we return to the sociology of bioethics to show that it can make only a limited contribution to the field. (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)

Empirical-ethical research constitutes a relatively new field which integrates socio-empirical research and normative analysis. As direct inferences from descriptive data to normative conclusions are problematic, an ethical framework is needed to determine the relevance of the empirical data for normative argument. While issues of normative-empirical collaboration and questions of empirical methodology have been widely discussed in the literature, the normative methodology of empirical-ethical research has seldom been addressed. Based on our own research experience, we discuss one aspect of this normative (...) methodology, namely the selection of an ethical theory serving as a background for empirical-ethical research. (shrink)

Some health care organizations allow physicians to withhold cardiopulmonary resuscitation from a patient, despite patient or surrogate requests that it be provided, when they believe it will be more harmful than beneficial. Such cases usually involve patients with terminal diagnoses whose medical teams argue that aggressive treatments are medically inappropriate or likely to be harmful. Although there is state-to-state variability and a considerable judicial gray area about the conditions and mechanisms for refusals to perform CPR, medical teams typically follow a (...) set of clearly defined procedures for these decisions. The procedures are based on the principle of nonmaleficence and typically include consultation with hospital ethics committees, reflecting the guidelines of relevant professional associations. Ethical debates about when CPR can and should be limited tend to rely more on discussions of theory, principles, and case studies than systematic empirical study of the situations in which such limitations are applied. Sociologists of bioethics call for empirical study, arguing that what ethicists and health professionals believe they are doing when they draft policies or invoke principles does not always mirror what is happening on the ground. In this article, we begin the task of modeling the empirical analyses sociologists call for, focusing on a cohort at Massachusetts General Hospital. We inductively analyzed ethics committee notes and medical records of nineteen patients whose surrogates did not accept the decision to withhold CPR. (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 consolidation of the interdisciplinary field of bioethics in Europe and in the United States was accompanied by harsh criticisms by the social sciences; criticisms that have endured and been reshaped from the late twentieth century until the present. This article begins with a critical discussion of the myopia detected in a bioethical thought that has systematically disregarded its origins, both cultural and social. I claim that this deficit could be rectified if social scientists, in general, and sociologists, in particular, (...) were to move away from the periphery, which they still occupy today, and take up a central position in the area of bioethics. In order to analyze the distant and controversial relationship between the social sciences and bioethics, I proceed to an analysis of their various approaches, respectively guided by descriptive and normative ethics. The specific intersection of sociologists with bioethical thought will be scrutinized, in accordance with an analytical continuum that illustrates an evolution from a collaborative position to a free and independent position adopted by the social scientists. The article concludes by presenting a suggestion regarding the integration of the sociological imagination in the processes of ethical deliberation on the moral problems that emerge in biomedical research and clinical practice. In this context, further epistemological reflection is invited regarding the influence of socio-cultural sources of morality relating to the manner in which such problems have been challenged by the bioethical imagination. (shrink)

As one of the most compelling technologies for imaging the brain, functional MRI (fMRI) produces measurements and persuasive pictures of research subjects making cognitive judgments and even reasoning through difficult moral decisions. Even after centuries of studying the link between brain and behavior, this capability presents a number of novel significant questions. For example, what are the implications of biologizing human experience? How might neuroimaging disrupt the mysteries of human nature, spirituality, and personal identity? Rather than waiting for an ethical (...) agenda to emerge from some unpredictable combination of the concerns of ethicists and researchers, the attention of journalists, or after controversy is sparked by research that cannot be retracted, we queried key figures in bioethics and the humanities, neuroscience, media, industry, and patient advocacy in focus groups and interviews. We identified specific ethical, legal and social issues (ELSI) that highlight researcher obligations and the nonclinical impact of the technology at this new frontier. (shrink)

A selection of recent sociological literature dealing with bioethics, concentrating particularly on its interface with research ethics, is reviewed to reveal that the two disciplines of bioethics and sociology have tendencies to approach subject matters from opposed perspectives. These differences in approach have now been generally recognized, accepted and accommodated by proponents of both disciplines. A turning point in the relationship between the two disciplines may have been reached which augers greater mutual respect, appreciation and even learning.

Research ethics committees ‘ members’ perceptions of their role in regard to the science of research proposals are discussed. Our study, which involved the interviewing of 20 participants from amongst the UK’s independent ethics committees, revealed that the members consider that it is the role of the REC to examine and approve the scientific adequacy of the research – and this notwithstanding the fact that a more competent body will already have done this and even when that other body has (...) the legal responsibility for this function. The problematic nature of this situation, tantamount to double jeopardy, is considered: it can delay research and so add to costs whilst offering no countervailing benefits, or the double jeopardy may be just the cost society imposes, through its RECs, on researchers as the price for research on human subjects. (shrink)

Scientific developments take place in a socio-political context but scientists often ignore the ways their innovations will be both interpreted by the media and used by policy makers. In the rush to neuroscientific discovery important questions are overlooked, such as the ways: (1) the brain, environment and behavior are related; (2) biological changes are mediated by social organization; (3) institutional bias in the application of technical procedures ignores race, class and gender dimensions of society; (4) knowledge is used to the (...) advantage of the powerful; and (5) its applications may reinforce existing structures of power that pose ethical questions about distributive justice. The case of crime, deception and functional Magnetic Resonance Imaging (fMRI) shows the complexity, and the political and ethical challenges that confront those who seek to use neuroscience to explain the etiology of crime, and who base policy on its findings. An ethically grounded neuroscience needs to take account of existing structures of power and difference, and to develop a public neuropolitical consciousness that ensures that those subject to risk by the application of science and technology are participants in the decision-making processes involving the implementation of policies that affect them. (shrink)

Moral theory is an important guide to bioethical decision-making, but it can confuse and mislead those who offer ethical advice to clinicians and researchers, delaying decisions that must be made in a timely fashion. In this paper I examine the ways moral theory can lead bioethicists astray. Absent a sensitivity to the empirical realities of ethical problems, moral theory 1) contributes to the disappearance of the persons caught in an ethical quandary, 2) focuses on the puzzle-solving rather than examining the (...) conditions that generate moral problems, and 3) universalizes ethical dilemmas, overlooking local processes for resolving moral questions. Taken together, empirically informed moral theory and theoretically informed empirical research can help bioethicists transcend the is/ought problem in ethical work. (shrink)