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Abstract: In 1948 Ludwik Fleck published a paper in Polish discussing the use of humans in medical experiments, thereby addressing his peers. Though the paper has so far not been translated or studied, it has been taken to indicate Fleck’s deep commitment to ethical questions, notably the question of informed consent. In being written by a former victim of the Nazi policy and a survivor of the Holocaust also acting as an expert witness in the trial of the IG Farben in Nuremberg, the paper is of interest. A scrutiny of Fleck’s text and related sources discloses, however, not only the complexity of the issue at the centre of the Nuremberg trial, but also Fleck’s unexpected stance in seemingly adducing his arguments from both the German defendants and the prosecution, heavily informed by US scientists. Further, the contentious discussion of the past in Fleck’s paper reveals its links to modern bioethical discussion. Though sometimes oblivious of that past, it still faces the same questions. [Copyright &y& Elsevier]

Background: In our multicultural society, as well as when working internationally, emergency physicians (EPs) frequently see patients from cultures with communitarian or hierarchal structures. These groups may rely on traditional medical practices and view health care decisions through a lens other than patient autonomy. This leads to uncertainty about who can legitimately make decisions for patients and how to apply basic ethical principles. Because the commonly taught ethical principles (autonomy, beneficence, nonmaleficence, and distributive justice) are loosely defined, they provide little help to EPs when working with cultures that de-emphasize Western individualism.Case Report: The case illustrates this complexity by detailing how visiting EPs dealt with leaders from a communitarian culture who demanded that a preteen be treated for a femur fracture by a traditional bone healer rather than with modern techniques.Discussion: The Western-trained clinicians struggled with their ethical responsibility to protect the child's welfare within the social setting: What should beneficence look like in this situation and to whom did it apply? More broadly, this paper examines the bases on which health care professionals might justify overruling parental decisions. It also asks whether the lack of clarity of the most used Western ethical principles suggests the need to broaden clinical ethics education to include issues from other cultures and settings.Conclusions: Despite principlism's shortcomings, the ease of teaching ethics to health care providers by grouping basic philosophical ideas suggests that we continue to use its structure. As educators and practitioners, we should, however, expand the concept of principlism to better address ethical values and issues found across different cultures. [ABSTRACT FROM AUTHOR]

Background: Due to the aging of the population, cancer has become a health priority worldwide. While the number of elderly cancer patients is rapidly increasing, many barriers still exist to their effective management. Compared with their younger counterparts, the elderly are less likely to receive optimal medical, psychological and spiritual treatment provided in a culturally competent manner. Design: The scanty literature on cultural competence in elderly cancer patients has been reviewed. Additional material has been selected based on the authors' clinical research in medical oncology and psycho-oncology, and on their scholarly work in anthropology and bioethics. Results: The aging process is a synergistic product of biological, behavioral and social issues within a cultural context. Knowledge about how older people understand, perceive and experience their illness trajectory and make choices is essential to the planning and delivering of effective cancer care. Conclusion: This position paper of the SIOG Task Force on Cultural Competence in the Elderly creates awareness of the influence of culture in geriatric oncology. Negotiating cross-cultural issues in geriatric oncology helps managing possible conflicts between patients, families and physicians over differing health care values, beliefs, or practices. Possible areas of future scholarly investigation and clinical research are identified. [ABSTRACT FROM AUTHOR]

Modern advances in assisted reproduction technology (ART) have disrupted the traditional concept of parenthood. Every year, thousands of people travel abroad from their home countries in order to circumvent restrictive legislation or to benefit from lower fees. In a similar context, surrogacy raises many bioethical and legal issues. The present paper will address the main questions arising from the debate prompted by surrogacy, focusing on international legislation, and looking critically at the different legislative models. As a result of worldwide heterogeneity in policies, legal approaches, and access to ART throughout the world, a growing number of would-be parents are seeking treatment abroad. The lack of regulation on cross-border surrogacy in low income countries can undermine the dignity and rights of women as even modest economic compensation determines a significant purchasing power. The international effort should be aimed at creating an international regulatory framework from which guidelines useful to national governments derive. An international agreement would provide a solid legal basis for the protection of surrogate women. In order to limit the economic interests linked to procreative tourism, so as to truly protect global health and women's rights, legislative uniformity is therefore necessary between the various states. [ABSTRACT FROM AUTHOR]

Controlled organ donation after circulatory death (DCD) has recently been revived in the UK, as part of attempts to increase organ donation rates. The re-introduction of DCD has subsequently become the focus of bioethical controversy, since it necessitates intervening in the care of dying patients to obtain quality donor organs. Transplant policy responses to these concerns have generated new legal and ethical guidelines to address uncertainties around DCD, producing claims that the UK has overcome’ the ethical challenge of DCD. In contrast, by drawing on Lynch's call to ‘respecify’ ethics, this paper argues that ethics in DCD cannot be reduced to abstract directives for practice, but, instead, are composed and dealt with as an organisational problem. To do this, I utilise data from an ethnographic study examining the production of the ‘minority ethnic organ donor’ within UK organ donation settings; in particular, the data pertains to a case hospital which was in the process of developing a DCD programme during the period of fieldwork. Findings show that the ethics of DCD are encountered as practical sets of problems, constructed in relation to particular institutional locales. I describe how these issues are worked-around by creating conditions to make DCD organisationally possible, and through the animation of standard procedures into acceptable forms of practice. I argue that ethics in DCD go far beyond normative bioethical principles, to encompass concerns around: the reputation of hospital Trusts, public perceptions of organ donation, the welfare of potential donor families, and challenges to the work of health professionals caring for dying patients. The paper enriches understanding of ethics in science and medicine by showing how ethics are assembled and negotiated as a practical-organisational concern, and calls for further examination of how DCD gets constructed as a potential problem and is made to happen in practice. [ABSTRACT FROM AUTHOR]

Objectives Highlight the importance of teamwork in health care institutions by performing a review and discussion of the relevant literature. Study design Review paper. Methods A MEDLINE/Pubmed search was performed starting from 1990, and the terms 'team, teamwork, managers, healthcare, and cooperation' were searched in titles, abstracts, keywords, and conclusions; other terms 'patient safety, ethics, audits and quality of care' were specifically searched in abstracts and were used as additional filters criteria to select relevant articles. Results Thirty-three papers were found relevant; factors affecting the quality of care in health care institutions are multiple and varied, including issues related to individual profile, to administrative structure and to team-based effort. Issues affecting teamwork include mainly self-awareness, work environment, leadership, ethics, cooperation, communication, and competition. Moreover, quality improvement plans aiming to enhance and expand teams are essential in this context. Team monitoring and management are vital to achieve efficient teamwork with all the required qualities for a safer health system. In all cases, health managers' responsibility plays a fundamental role in creating and sustaining a teamwork atmosphere. Conclusion Teamwork is known to improve outcomes in medicine, whether at the clinical, organizational, or scientific level. Teamwork in health care institutions must increasingly be encouraged, given that individual effort is often insufficient for optimal clinical outcome. [ABSTRACT FROM AUTHOR]

The global political economy of stem cell therapies is characterised by an established biomedical hegemony of expertise, governance and values in collision with an increasingly informed health consumer demand able to define and pursue its own interest. How does the hegemony then deal with the challenge from the consumer market and what does this tell us about its modus operandi ? In developing a theoretical framework to answer these questions, the paper begins with an analysis of the nature of the hegemony of biomedical innovation in general, its close relationship with the research funding market, the current political modes of consumer incorporation, and the ideological role performed by bioethics as legitimating agency. Secondly, taking the case of stem cell innovation, it explores the hegemonic challenge posed by consumer demand working through the global practice based market of medical innovation, the response of the national and international institutions of science and their reassertion of the values of the orthodox model, and the supporting contribution of bioethics. Finally, the paper addresses the tensions within the hegemonic model of stem cell innovation between the key roles and values of scientist and clinician, the exacerbation of these tensions by the increasingly visible demands of health consumers, and the emergence of political compromise. [ABSTRACT FROM AUTHOR]

The rapid growth of the aquaculture sector over the past forty years can be closely linked to advances in science and technology. Some innovations in biotechnology have proven more controversial than others, and none more so than proposals for transgenic fish. Such innovations introduce concerns for the responsible governance of research and innovation for aquaculture, particularly in recognition of the significant uncertainties and high stakes characterising these technologies. This paper argues in favour of a participatory approach to the governance of contentious aquaculture technologies that includes an ‘upstream’ regard for their ethical and social implications. From this point of departure, the paper presents empirical research that employed one particular approach to engage aquaculture stakeholders from Northern Europe in deliberation over the ethical and social considerations of transgenic growth-enhanced salmon, using the ‘ethical matrix’ tool. This research explores the complexity of considerations raised by these small groups of diverse and knowledgeable stakeholders across workshops in Germany, Norway and the United Kingdom, and links them with wider ethical discussions in the bioethics literature. The dual ambitions of the paper are to first provide insights into an applied approach for incorporating ethical reasoning in processes for responsible aquaculture techno-innovation, and second to provide an appreciation for the plurality of considerations that decision-makers need to navigate and carefully weigh when reaching a decision on the appropriateness of the particular transgenic growth-enhanced salmon. [ABSTRACT FROM AUTHOR]

Organ transplants are not regarded as an exclusively medical process, because they involve financial, religious, philosophic, and bioethical parameters. It becomes clear that if they are to achieve their purpose, which we believe extends well beyond the medical dimension, the creation of a comprehensive framework of communication between the involved parties is of paramount importance. The aim of this paper is to present an outline and a number of considerations regarding the communicational, bioethical, and legal issues that arise from a rather dramatic state of affairs in Greece today: In 2012 the rate of organ transplants stood at only 7 per 1 million of the population. The outdated legal framework and the lack of trust on the part of patients and the public have led to a highly inefficient system that is lagging behind in many respects. The proposition made in this paper is that there is a need for a new system of communication between doctors, patients, relatives of patients, and hospitals: bioethical mediation. This is a system that has played a vital role and has produced astounding results in other countries. There is also every indication that the introduction of such a system is crucial for Greece, especially as the symptoms of the acute financial crisis are become fully visible and tangible. Mediation aims to identify solutions that are oriented toward the interests and wishes of patients, are acknowledged and accepted by all parties involved, and are in tune with the values and the principles of medical practice. [ABSTRACT FROM AUTHOR]

Abstract: Data collectors play a vital role in producing scientific knowledge. They are also an important component in understanding the practice of bioethics. Yet, very little attention has been given to their everyday experiences or the context in which they are expected to undertake these tasks. This paper argues that while there has been extensive philosophical attention given to ‘the what’ and ‘the why’ in bioethics – what action is taken place and why – these should be considered along ‘the who’ – who are the individuals tasked with bioethics and what can their insights bring to macro-level and abstract discussions of bioethics. This paper will draw on the philosophical theories of Paul Ricoeur which compliments a sociological examination of data collectors experiences and use of their agency coupled with a concern for contextual and institutional factors in which they worked. In emphasising everyday experiences and contexts, I will argue that data collectors' practice of bioethics was shaped by their position at the frontline of face-to-face interactions with medical research participants and community members, alongside their own personal ethical values and motivations. Institutional interpretations of bioethics also imposed certain parameters on their bioethical practice but these were generally peripheral to their sense of obligation and the expectations conferred in witnessing the needs and suffering of those they encountered during their quotidian research duties. This paper will demonstrate that although the principle of autonomy has dominated discussions of bioethics and gaining informed consent seen as a central facet of ethical research by many research institutions, for data collectors this principle was seldom the most important marker of their ethical practice. Instead, data collectors were concerned with remedying the dilemmas they encountered through enacting their own interpretations of justice and beneficence and imposing their own agency on the circumstances they experienced. Their practice of bioethics demonstrates their contribution to the conduct of research and the shortcomings of an over-emphasis on autonomy. [Copyright &y& Elsevier]

Abstract: This paper explores two lines of development in the donor consent procedures in post-Soviet Latvia. The paper is based on secondary analysis of interview, focus group discussion data, and media and legal text material collected throughout three previously conducted research projects on organ transplantation, population genome project and xenotransplantation focusing on the historical development of the issues of donor consent across these three fields of medical technologies. The paper argues that the quality of consent depends not as much on political and legal change per se as on the strengthening of the position of both medical specialists and donors, facilitating bonds between the two. [Copyright &y& Elsevier]

Migration is a significant feature of the political discourse around the world. It is bewildering and polarizing policy makers, leaders and communities, grappling to address the questions raised. The growing body of empirical data on migrant health have profound ethical relevance for example around risk-benefit-analysis, justice and discrimination at the individual, micro, meso and macro levels. The policy decisions and actions to address the issues appear to be often guided by self-interest and increasing pressures to protect national interests, and the current structures and systems. This paper briefly outlines and reflects on the ethical dimensions of migration, diversity and health and implications for policy, and practice. We argue that there is a case for new paradigms of global solidarity, social justice, and health equity in an interconnected world. Health care for migrants should be built on values of equal human rights and of shared humanity and the health and wellbeing of migrants and citizens should be promoted and protected alike. Migrant health is of global concern and international strategies for global governance are required. Migration policies it is suggested should be based on the understanding of interconnectedness of our societies and founded on shared humanity, and health equity for all. There is a case to reimagine the earth as one country and humankind its citizens with its implications on policy and practice and the organized efforts of society. [ABSTRACT FROM AUTHOR]

This paper examines the principle of beneficence in the light of moral and epistemological concerns that have crystallized in the South African context around clinical care. Three examples from the South African experience affecting the development of bioethics are examined: medical colonialism, the death in detention of Steve Biko, and the HIV/AIDS epidemic. Michael Gelfand's book [(1948). The sick African: a clinical study. Cape Town: Stewart Printing Company.] on African medical conditions captures the ambiguous nature of colonial medicine that linked genuine medical treatment with the civilizing mission. Biko's death was a key historical event that deeply implicated the medical profession under apartheid. The present HIV/AIDS epidemic presents the gravest social and political crisis for South African society. All three experiences influence the meaning and relevance of beneficence as a bioethics principle in the South African context. This paper argues for a South African bioethics informed by a critical humanism that takes account of the colonial past, and that does not model itself on an “original wound” or negation, but on positive care-giving practices. [Copyright &y& Elsevier]

Moral distress is a pervasive phenomenon that can negatively impact healthcare professionals and has been well studied in nursing populations. Much of the evidence suggests that it is associated with intention to leave high acuity areas and the profession. Despite the increasing amounts of research to explore the causes and effects of moral distress, there is limited research on interventions that mitigate the negative effects of moral distress. The aims of this systematic review were to: (a) identify and examine interventions developed to address moral distress experienced by health care professionals (b) examine the quality of the research methods and (c) report on the efficacy of these interventions. We conducted a systematic review of interventional studies developed to mitigate moral distress. Medline, Embase, PsycINFO, CINAHL and Cochrane were searched for relevant studies (July 2019- September 2019). Additional bioethics databases and reference lists were also hand-searched. The first author reviewed all retrieved titles and abstracts with a low tolerance for borderline papers based on inclusion and exclusion criteria, and those papers were reviewed and discussed by all authors to determine inclusion. Quality appraisal was conducted on the included studies using narrative synthesis to compare the findings. Data were extracted and compared by all authors and then reviewed by the first author for consistency. Sixteen papers were included for full text review and the following interventions identified: educational interventions of varying length and breadth; facilitated discussions ranging from 30 to 60 minutes; specialist consultation services; an intervention bundle; multidisciplinary rounds; self-reflection and narrative writing. Researchers reported statistically significant reductions in moral distress using pre and post surveys, including one mixed methods program evaluation (n=7). The qualitative program evaluation provided participant quotations to suggest their program was beneficial. There were no statistically significant findings in the other studies (n=8). All studies had limitations in design and methodology presenting significant threats to validity. Designing rigorous research studies that measure the impact of interventions aimed at mitigating moral distress continues to be challenging. The primary reason being that moral distress is a subjective ethical phenomenon with a number of different causes and effects. This calls for interventions that are flexible and sensitive to individual's needs. To build an evidence-base, interventions should also be measurable and research methods need to be scientifically rigorous. To achieve rigor and innovation, researchers should clearly justify their methodological choices. Tweetable abstract: Interventions to mitigate moral distress: a systematic review of the literature. Educational interventions offer a promising direction but more research is needed. [ABSTRACT FROM AUTHOR]

Abstract: Background: People who are street involved including those experiencing homelessness and substance use are at increased risk of morbidity and mortality. Such inequities are exacerbated when those facing the greatest inequities in health have the least access to health care. These concerns have rarely been addressed in bioethics and there has been a lack of explicit attention to the dominant societal and organizational values that structure such injustices. The purpose of this paper is to describe the underlying value tensions that impact ethical nursing practice and affect equity in access to health care for those who are street involved. Methods: In this paper, findings from a larger qualitative ethnographic study of ethical practice in nursing in the context of homelessness and substance use are reported. The original research was undertaken in two ‘inner city’ health care centres and one emergency department (ED) to gain a better understanding of ethical nursing practice within health care interactions. Data were collected over a period of 10 months through face-to-face interviews and participant observation. Results: In order to facilitate access to health care for those who are street-involved nurses had to navigate a series of value tensions. These value tensions included shifting from an ideology of fixing to reducing harm; stigma to moral worth; and personal responsibility to enhancing decision-making capacity. A context of harm reduction provided a basis for the development of relationships and shifted the moral orientation to reducing harm as a primary moral principle in which the worth of individuals and the development of their capacity for decision-making was fostered. Conclusions: Implementation of a harm reduction philosophy in acute care settings has the potential to enhance access to health care for people who are street involved. However, explicit attention to defining the harms and values associated with harm reduction is needed. While nurses adopted values consistent with harm reduction and recognized constraints on personal responsibility, there was little attention to action on the social determinants of health such as housing. The individual and collective role of professional nurses in addressing the harms associated with drug use and homelessness requires additional examination. [Copyright &y& Elsevier]

Abstract: This paper situates discussion of the ethics of ethnographic research against the background of a theoretical and methodological debate about the relationship between ethics and method, and about the relationships between research methods and their objects. In particular, the paper investigates the implications of folding together the ethical and the empirical in research and argues that this requires the development of new ethico-ethnographic methods for the investigation of ethico-moral objects. The paper falls into three main parts. The first considers calls for what has come to be known as empirical ethics, that is, for a more empirically informed bioethics, by way of an exploration of the integration of ethnographic methods in bioethics, and concludes that approaches which see the ethical and the empirical as ‘complementary’ do not do justice to the methodological implications of enfolding the ethical and the ethnographic. The second part juxtaposes this with calls for the integration of ethics in ethnography and, similarly, argues that the enfolding of the ethical and the empirical in ethnography calls for the development of new methods. The paper goes on to problematise the ‘negotiational’ approaches to informed consent preferred by many ethnographers, arguing that the concept of negotiation, rather than offering a solution to the problem of consent, is itself ethically complex and in need of analysis. The paper argues that, in the context of ethnographic research, the possibility of negotiational forms of consent depends upon engagement between researchers and researched, with unavoidably ‘ethical’ concepts such as ‘respect’, ‘recognition’, ‘dignity’, ‘justice’ and so on, and that this poses methodological challenges to ethnography. The paper''s third section explores the implications of these arguments for research practice, using The Genethics Club as an example. [Copyright &y& Elsevier]

Abstract: The paper discusses central moral issues raised by the applications of advanced biotechnology to animal agriculture and introduces the major ethical concepts and principles of animal bioethics. It is argued that biotechnology enables human beings to transform animals according to human needs, which blurs the boundary between humans and non-human animals in moral and biological sense. The more humans change animals, the more responsible humans are for the welfare of the animals and the greater their moral obligations. The paper introduces the main ethical approaches to animal welfare, traces the philosophical roots of animal ethics in the Judeo-Christian tradition and discusses the views of classical and contemporary ethicists such as Kant, Bentham, Mill, Peter Singer and Tom Regan. The paper explores the concept of animal welfare, suffering and rights, and the values behind Animal Liberation. Special attention is given to the animal welfare issues posed by cloning, genetic engineering and patenting of living organism. For each technology, actual or potential risks to animal welfare are identified and their moral implications are outlined. It is noted that the traditional moral principles of animal welfare, animal interests and animal rights are inadequate as means for evaluating the morality of certain advanced technologies because the technologies can change the animals in profound ways that make animal awareness too limited to give rise to claims about welfare, interests or rights. The principle of animal integrity is endorsed as an alternative better suited for evaluating the morality of advanced biotechnology. [Copyright &y& Elsevier]

Abstract: This paper considers how internationally supported medical research is understood and interpreted by its actual and potential study subjects, exposing the limits to bioethical discourses amidst economic inequalities and contrasting socio-cultural worlds. It focuses on the Medical Research Council (MRC) Laboratories in The Gambia and particularly their Pneumococcal Vaccine Trial (PVT) that was conducted jointly with the Gambian government during 2001–2004. In many respects this was an exemplar of international best practice in trial communication and informed consent procedures. Yet ethnographic and survey research finds that Gambian parents’ perspectives on participation are shaped not by trial specificities, but by broader, historically shaped views and experiences of the MRC as an institution. There is a pervasive view that the MRC offers good, free medication to participants, but that it also ‘steals blood’. Widespread concerns with blood-stealing emerge from local frames of understanding in which blood is treated as a tradeable good, in which blood accumulation and depletion in bodily processes relates to its exchange in hospital and medical research practices, and in which transactions can be more or less (un)reasonable. Yet such thinking, rooted in an ‘economy of blood’, has been overlooked by medical research staff and indeed by historians and anthropologists of Africa whose analyses of blood-stealing have been overly transfixed on rumour and the occult. This paper argues that such cultural framings, which guide local critical commentary on trans-national research orders, require serious attention and need to inform open dialogues between scientists and the public if medical research in resource-poor settings is to continue to be sustainable and politically legitimate. [Copyright &y& Elsevier]

Abstract: Bioethics needs to include study of the social and historical context in which ethical meanings in medical encounters make sense. It needs to do this in order to remain relevant, vibrant, and aware of how it might unwittingly facilitate the agendas of others. As an illustration, this paper critiques some of the accepted meanings and purposes of the idea of the Therapeutic Misconception (TM) which has been an increasingly attractive concept with which to organize thinking about experimentation ethics. By considering the history of alternative viewpoints against which TM was offered as a replacement, this paper suggests that TM, and bioethics more generally, may contribute to increasingly technocratic and standardized practices in medicine. [Copyright &y& Elsevier]

Bioethics has been subject to considerable social criticism in recent years. One criticism that has caused particular discomfort in the bioethics community is that bioethicists, because of the way their work is funded, are involved in profound conflicts of interest that undermine their title to be considered independent moral commentators on developments in biomedicine and biotechnology. This criticism draws its force from the assumption that bioethics is, or ought to be, a type of normative social criticism. Versions of this criticism come from both the political left and right. For instance, such criticisms include allegations that bioethics is inherently socially conservative, that it is inherently “pro-technology”, that it lays spurious claims to moral and social authority and expertise, that its focus on autonomy links it to neoliberal theories of choice, and that it is an ideological mystification of real social relationships and political power. This commentary paper analyses the problem of bioethical conflict of interest, and argues that the types of conflict of interest facing bioethics are inherent to the role of “public intellectual” that bioethicists generally wish to assume. The paper defends this conception of the role of the bioethicist, arguing that bioethicists should be interested and openly so. [Copyright &y& Elsevier]

Embryos have different meanings for different people and in different contexts. Seen under the microscope, the biological embryo starts out as one cell and then becomes a bunch of cells. Gradually these divide and differentiate to make up the embryo, which in humans becomes a fetus at eight weeks, and then eventually a baby. At least, that happens in those cases that carry through normally and successfully. Yet a popular public perception imagines the embryo as already a little person in the very earliest stages of development, as if it were predictably to become an adult. In actuality, cells can combine, pull apart, and recombine in a variety of ways and still produce embryos, whereas most embryos never develop into adults at all. Biological embryos and popular imaginations of embryos diverge. This paper looks at some of the historical reasons for and social implications of that divergence. [ABSTRACT FROM AUTHOR]

The issue of balance between research and treatment in clinical trials conduct has been surrounded by controversies. Scientific characteristics of trials may compromise medical care available to participants, while conceiving research participation as having therapeutic value may foster the therapeutic misconception. However, it has also been questioned whether research can and should always be separated from medical care provision. In this paper we analyze how these concerns played out in practice settings of the three trial sites in Russia, specialized in trials in cardiovascular diseases. Using in-depth interviews with participants of phase II and III trials (n = 21) and discussions with physician-investigators (n = 7), we found that trial enrollment allowed participants to establish continuous supportive relationships with the physician-investigators. In the context of unresponsive health care, chronically ill participants received regular monitoring, treatment recommendations and help in case of problems and emergencies through such relationships. The trial designs in the three sites did not preclude the provision of individualized treatment. We suggest that debates about the research/treatment interface in trials need to become more attuned to the conditions in locations of their conduct, views and experiences of actors involved and evolving trial methodologies. Too much focus on categorical differentiation of research and treatment may obscure the fact that globalizing clinical trials proceed amidst profound health disparities, dismiss diverse concerns of people on the ground and risk attenuating responsibilities of trial organizers, sponsors and investigators towards research participants. [ABSTRACT FROM AUTHOR]

Introduction: Recent developments in the field of Artificial Intelligence (AI) applied to healthcare promise to solve many of the existing global issues in advancing human health and managing global health challenges. This comprehensive review aims not only to surface the underlying ethical and legal but also social implications (ELSI) that have been overlooked in recent reviews while deserving equal attention in the development stage, and certainly ahead of implementation in healthcare. It is intended to guide various stakeholders (eg. designers, engineers, clinicians) in addressing the ELSI of AI at the design stage using the Ethics by Design (EbD) approach.Methods: The authors followed a systematised scoping methodology and searched the following databases: Pubmed, Web of science, Ovid, Scopus, IEEE Xplore, EBSCO Search (Academic Search Premier, CINAHL, PSYCINFO, APA PsycArticles, ERIC) for the ELSI of AI in healthcare through January 2021. Data were charted and synthesised, and the authors conducted a descriptive and thematic analysis of the collected data.Results: After reviewing 1108 papers, 94 were included in the final analysis. Our results show a growing interest in the academic community for ELSI in the field of AI. The main issues of concern identified in our analysis fall into four main clusters of impact: AI algorithms, physicians, patients, and healthcare in general. The most prevalent issues are patient safety, algorithmic transparency, lack of proper regulation, liability & accountability, impact on patient-physician relationship and governance of AI empowered healthcare.Conclusions: The results of our review confirm the potential of AI to significantly improve patient care, but the drawbacks to its implementation relate to complex ELSI that have yet to be addressed. Most ELSI refer to the impact on and extension of the reciprocal and fiduciary patient-physician relationship. With the integration of AIbased decision making tools, a bilateral patient-physician relationship may shift into a trilateral one. [ABSTRACT FROM AUTHOR]

There is considerable concern about increasing rates of anxiety and depression among children and young people (CYP). Mental health technologies, such as smartphone applications, are proposed as a potential solution. However, the effectiveness of mental health mobile applications for managing, moderating and treating anxiety and depression in CYP is uncertain. The purpose of this scoping review is to outline the extent of the clinical evidence base of mental health apps with monitoring functions for depression and anxiety in CYP, to categorise the range of monitoring features, to understand their various purposes, and to analyse these 'technical mechanisms' in apps from the perspective of critical ecological analysis. It provides a novel conceptual framework for researching how CYP may use and critically engage with mental health apps. We searched Ovid MEDLINE, PsycINFO, and Scopus databases, and 39 studies met the inclusion criteria. The analysis focuses attention on the ecological (mental, social and environmental) dimensions of life, health and emotional experience and the purposes of mental health monitoring apps. We evaluate the way that technical mechanisms , such as metrics are used in apps, examine their effects on responsibility for managing and treating distress and consider the rationalities that guide their development. The paper concludes that examination of the bioethics and neuroethics of these technologies is necessary and urgent. This requires paying closer attention to the social practices of technology-enabled self-monitoring, and the ways in which these frame mental health as a form of individualised emotional regulation. • Scoping review of apps for anxiety and depression for children and young people. • Provides typology and critical ecological analysis of mental health monitoring apps. • Effectiveness of mental health monitoring apps is uncertain. • Apps are not discrete 'tools', need to look at the contexts of their usage. • Monitoring apps reshape responsibilities for managing and treating distress. [ABSTRACT FROM AUTHOR]

Abstract: In a context of high rates of intimate partner violence (IPV), trials of female-controlled technologies for HIV prevention such as microbicides may increase the possibility of social harms. Seeking to explore the relationship between IPV and microbicide use further, this paper documents women's narratives of participating in the Microbicide Development Program (MDP) trial in Johannesburg, South Africa, and experiences of partner violence and conflict. A social science sub-study, nested within the trial, was conducted between September 2005 and August 2009, and 401 serial in-depth-interviews were undertaken with 150 women. Using coded interview transcripts, we describe the distribution of IPV and the possible association thereof with microbicide gel use and trial participation. More than a third of these 150 women reported IPV, of which half the cases were related to involvement in the trial. In their narratives, those women reporting IPV cast their partners as authoritarian, controlling and suspicious and reported verbal abuse, abandonment, and in some cases, beatings. Shared experiences of everyday violence shaped women's feelings of unease about revealing their participation in the trial to intimate partners and attempted concealment further contributed to strains and conflict within relationships. Our findings point to the role of social scientific enquiry in identifying the less obvious, hidden negative impacts of participation in a clinical trial therefore exposing limitations in the biomedical construction of ‘social harms’, as well as the implications thereof for potential future use outside the clinical trial setting. [Copyright &y& Elsevier]

Abstract: This paper investigates the question whether it is ethically justified to treat Parkinsonian patients with known or suspected pedophilia with deep brain stimulation — given increasing evidence that this treatment might cause impulse control disorders, disinhibition, and hypersexuality. This specific question is not as exotic as it looks at a first glance. First, the same issue is raised for all other types of sexual orientation or behavior which imply a high risk for harming other persons, e.g. sexual sadism. Second, there are also several (psychotropic) drugs as well as legal and illegal leisure drugs which bear severe risks for other persons. We show that Beauchamp and Childress' biomedical ethics fails to derive a veto against medical interventions which produce risks for third persons by making the patients dangerous to others. Therefore, our case discussion reveals a blind spot of the ethics of principles. Although the first intuition might be to forbid the application of deep brain stimulation to pedophilic patients, we argue against such a simple way out, since in some patients the reduction of dopaminergic drugs allowed by deep brain stimulation of the nucleus subthalamicus improves impulsive control disorders, including hypersexuality. Therefore, we propose a strategy consisting of three steps: (1) risk assessment, (2) shared decision-making, and (3) risk management and safeguards. [Copyright &y& Elsevier]

Abstract: Synthetic organisms are at the same time organisms and artifacts. In this paper we aim to determine whether such entities have a good of their own, and so are candidates for being directly morally considerable. We argue that the good of non-sentient organisms is grounded in an etiological account of teleology, on which non-sentient organisms can come to be teleologically organized on the basis of their natural selection etiology. After defending this account of teleology, we argue that there are no grounds for excluding synthetic organisms from having a good also grounded in their teleological organization. However, this comes at a cost; traditional artifacts will also be seen as having a good of their own. We defend this as the best solution to the puzzle about what to say about the good of synthetic organisms. [Copyright &y& Elsevier]

Abstract: Scientific progress in the life sciences is dependent on the governance of tensions between the economic potential of the innovation and the cultural response from society. Ownership of the scientific innovation through patenting is a necessary part of the realization of its economic value yet, in the case of human embryonic stem cell (hESC) science, ownership of the human body and human life may offend fundamental cultural values. In the case of transnational patenting governance by the European Patent Office (EPO) and the European Union (EU), cross-national cultural conflict in the field of hESC science has produced a political demand for a form of governance that can incorporate ethical as well as economic judgements in its decision making. This paper explores how bioethics has responded to this opportunity to establish itself as a form of expert authority for the negotiation and resolution of the cultural conflict. In so doing, it shows how the political struggle that has accompanied this bid for new governance territory has been influenced both by the political tensions between the EPO and EU systems of patenting governance and the resistance of competing experts in law and science to a bioethical presence. [Copyright &y& Elsevier]

Abstract: Numerous documents have been published by the national bioethics committees of the European Union and Council of Europe member countries on the subject of organ transplantation. The present paper examines those that address the question of living donation with a focus on kidney grafts. Although it is not possible to ensure absolute completeness since not all the documents produced over the years are accessible and English translations are often lacking, this review covered evaluations of the most significant ones. There has been a preponderance of attention to the issue of informed consent, while the issue of donor risk has been addressed only summarily, if at all. [Copyright &y& Elsevier]

The latest mammalian genetic modification technology offers efficient and reliable targeting of genomic sequences, in the guise of designer genetic recombination tools. These and other improvements in genetic engineering technology suggest that human germline genetic modification (HGGM) will become a safe and effective prospect in the relatively near future. Several substantive ethical objections have been raised against HGGM including claims of unacceptably high levels of risk, damage to the status of future persons, and violations of justice and autonomy. This paper critically reviews the latest GM science and discusses the key ethical objections to HGGM. We conclude that major benefits are likely to accrue through the use of safe and effective HGGM and that it would thus be unethical to take a precautionary stance against HGGM. [ABSTRACT FROM AUTHOR]

Abstract: The global spread of clinical trials activity is accompanied by a parallel growth in research governance and human subject protection. In this paper we analyse how dominant ideas of the ‘human subject’ in clinical trials are played out in countries that are deemed to be scientifically under-developed. Specifically, we show how rhetorics of individualism, rationality and autonomy implicit in international ethical guidelines governing human subject research are operationalised and localised. We give insights into the ways in which new knowledge forms become embedded in practice. Using the recent upsurge in clinical trials in Sri Lanka as a case study, based on interviews with 23 doctors and researchers carried out during ethnographic fieldwork between 2008-2009, this article explores the tensions that arise for doctors involved with the promotion of bioethics and the attempts to bring local research governance up to international standards. The doctors and researchers intercept, interpret and critique the notions of human subject implicit in new forms of research governance. From their accounts we have identified two concerns. The first is a critique of dominant ideas of the ‘human subject’ that is informed by ideas of patiency rooted in paternalistic notions of the doctor-patient relationship. Second, ‘human subjects’ are seen as gendered, and located within family relationships. Both of these bring into question the research subjects’ ability to give informed consent and compromise the ideal of an autonomous subject. [Copyright &y& Elsevier]

Abstract: The purpose of this article is to present an analysis of the term “child''s interest” in some aspects of medically assisted procreation. The object of analysis is, on the one hand, French legal regulation of medically assisted procreation techniques and, on the other hand, the state of Polish preparations to conclude the legal process of bioethical law. As there is no legal definition of “child''s interest”, the authors present state of French and Polish doctrine and parliamentary working papers on this subject. The article answers the question whether and how it is possible to refer to the term “child''s interest” in the situation of an unborn child and even more a child who only is to be conceived. The authors especially concentrate their attention on the requirements allowing to apply medically assisted procreation. [Copyright &y& Elsevier]

Abstract: Paradoxically, France is one of the leading exporters of cord blood units worldwide, but ranks only 17th in terms of cord blood units per inhabitant, and imports 64% of cord blood grafts to meet national transplantation demands. With three operational banks in 2008, the French allogeneic cord blood network is now entering an important phase of development with the creation of seven new banks collecting from local clusters of maternities. Although the French network of public banks is demonstrating a strong commitment to reorganise and scale up its activities, the revision of France’s bioethics law in 2010 has sparked a debate concerning the legalisation of commercial autologous banking. The paper discusses key elements for a comprehensive national plan that would strengthen the allogeneic banking network through which France could meet its national medical needs and guarantee equal access to healthcare. [Copyright &y& Elsevier]

Abstract: Issues concerning the beginning of life and medical intervention in the onset of human existence are very delicate in their nature; they involve multi-dimensional knowledge, they are difficult to comprehend and sensitive to handle. When pure scientific elements are combined with profound emotions, when the genius of technological discoveries touches upon human dignity and sanctity, when passion for the technological achievement intervenes in basic human rights, then the sense of inadequacy and ignorance becomes intense and critical. Silence seems more sought-after than words, and willingness to learn more prudent than the desire to speak. Fear of the inconceivable consequences and even more so the inability to assess them, experiments with the unknown, the likelihood that basic historical, ethical and social values may change forever, but mainly the replacement of God in His wondrous work of creation – the onset of human life – places the ethics of reproductive technologies on the frontline of contemporary bioethics. This opinion paper does not deal with dangers, insults, fears, threats, “speed limits” or ethical controversies, but rather with the very mystery of life. Although there are no generally accepted replies to the various questions being posed, some thoughts and reservations, which can shed some light upon complicated dilemmas are presented. Firstly, the content of reproductive technologies, the problem of infertility today, the methods of fertility treatment, and of prenatal and pre-implantation testing are described, and then the social impact of IVF, complicated cases, deontological dilemmas and some ethical concerns are discussed. [Copyright &y& Elsevier]

Abstract: This paper focuses on ethical aspects of BCI, as a research and a clinical tool, that are challenging for practitioners currently working in the field. Specifically, the difficulties involved in acquiring informed consent from locked-in patients are investigated, in combination with an analysis of the shared moral responsibility in BCI teams, and the complications encountered in establishing effective communication with media. [Copyright &y& Elsevier]

Abstract: The aim of this paper is to offer an ethical perspective on the use of non-human primates in neurobiological studies, using the Parkinson''s disease (PD) as an important case study. We refer, as theoretical framework, to the 3R principle, originally proposed by Russell and Burch [Russell, W.M.S., Burch, R.L., 1959. The Principles of Humane Experimental Technique. Universities Federation for Animal Welfare Wheathampstead, England (reprinted in 1992)]. Then, the use of non-human primates in the study of PD will be discussed in relation to the concepts of Replacement, Reduction, and Refinement. Replacement and Reduction result to be the more problematic concept to be applied, whereas Refinement offers relatively more opportunities of improvement. However, although in some cases the 3R principle shows its applicative limits, its value, as conceptual and inspirational tool remains extremely valuable. It suggests to the researchers a series of questions, both theoretical and methodological, which can have the results of improving the quality of life on the experimental models, the quality of the scientific data, and the public perception from the non-scientist community. [Copyright &y& Elsevier]

Abstract: Currently, the accepted ethical standards for the regulation of animal experimentation are provided by the 3R principle (Replacement, Reduction and Refinement). The development of alternative methods to the use of animals (Replacement), the design of adequate experimental protocols to reduce the number of animals (Reduction), the application of refinement practices (Refinement) are all aspects to be considered to ensure ethical and scientific validity to animal experimentation. This review intends to address these issues, using experimental research on Parkinson’s disease (PD) as a paradigmatic example of the use of animal models to improve knowledge on a devastating human pathology. In particular, current rodent models of PD and their validity are reviewed and discussed, and methodologies that may ultimately reduce animal’s suffering emphasized. Although procedures referring to with 3R principle can be traced in the literature reviewed, they are not considered yet an important part of the methodological information. The formal inclusion in scientific papers of a section devoted to 3Rs may increase knowledge and eventually adherence to this principle by scientists. [Copyright &y& Elsevier]

Dor Yeshorim, the premarital carrier testing program designed and implemented by the ultra-orthodox Jewish community, has succeeded in generating high uptake thus considerably reducing the number of children born with genetic diseases. Those critical of the program stress its directive and coercive features which are said to compromise personal autonomy, while those in favor emphasize its efficiency, cultural fit, and the reduction of stigma. This debate has so far, however, been addressed only from a top-down view representing the theories of community leaders and bioethicists, while the actual meaning and practice of carrier matching as experienced by community members have remained unexplored. Based on interviews with 24 ultra-orthodox women and 5 matchmakers in Israel, as well as on observations of instructions in the community, this exploratory study shows how Dor Yeshorim has been selectively incorporated into the traditional matchmaking process. We examine the unintended consequences of this selective assimilation, namely how messages that propagate ignorance and fear, as well as misunderstandings regarding the genetic basis of carrier matching, reinforce the continuing stigmatization of presumed carriers. The paper concludes by discussing the findings in the broader context of the social analysis of the ethics of community genetics. [Copyright &y& Elsevier]

Abstract: This paper reviews the development of precision livestock farming (PLF), from the view point of the engineer, the farm animal and the farmer; PLF is the principal means by which ‘smart’ sensors will be used in livestock farming. It considers the technological principles upon which PLF is based, gives several examples of PLF, considers which livestock processes are suitable for the PLF approach, addresses whether PLF constitutes technology push or market pull, and stresses the need for a prospective bioethical analysis of PLF. We conclude that PLF is an embryonic technology with great promise but one that requires considerable research and development before uptake. [Copyright &y& Elsevier]

Abstract: There is wide acknowledgement of the need for community engagement in biomedical research, particularly in international settings. Recent debates have described theoretical approaches to identifying situations where this is most critical and potential mechanisms to achieve it. However, there is relatively little published experience of community engagement in practice. A major component of the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme is centred on Kilifi District General Hospital and surrounding community of 240,000 local residents. Documented community perceptions of the research centre are generally positive, but many indicate a low understanding of research and therapeutic misconceptions of its activities. As in other settings, these misunderstandings have contributed to concerns and rumours, and potentially undermine ethical aspects of research and local trust in the institution. Through a series of consultative activities, a community engagement strategy has been developed in Kilifi to strengthen mutual understanding between community members and the Centre. One important component is the establishment of a representative local resident network in different geographic locations commonly involved in research, to supplement existing communication channels. Early implementation of the strategy has provided new and diverse opportunities for dialogue, interaction and partnership building. Through the complex social interactions inherent in the community engagement strategy, the centre aims to build context specific ethical relations with local residents and to strengthen understanding of how ethical principles can be applied in practice. Evaluations over time will assess the effectiveness and sustainability of these strategies, provide generalisable information for similar research settings, and contribute to debates on the universality of ethical principles for research. This paper aims to summarise the rationale for community engagement in research, drawing on published literature and local findings, to outline the process of community engagement in Kilifi and to describe issues emerging from its development and early implementation. [Copyright &y& Elsevier]

Abstract: Objective: To describe the principal role of value judgments in the analysis and synthesis of evidence as they are involved in systematic reviews, meta-analyses, and health technology assessments. Method: Using the tools of conceptual analysis, we characterize three main types of value judgments and propose an outline of how to enhance the appropriate role of value judgments in the process of analyzing and synthesizing evidence. Results: The production, analysis, and synthesis of evidence involve value judgments characterized as preferences of persons or groups that cannot be validated by appeal to facts alone. Because preferences across individuals can vary, value judgments can be a source of bias in science and unwarranted variation in the application of scientific evidence. However, it is not possible or desirable to eliminate all value judgments in the process from production to synthesis of evidence. Conclusion: With respect to the value judgments that shape the analysis and synthesis of evidence, review authors should disclose and justify choices related to the three key value judgments outlined in this paper. Authors should also highlight how their value judgments differ from the stated or implicit value judgments of previously published reviews on the same topic. [Copyright &y& Elsevier]

The research literature about ‘brain death’ is largely characterized by biomedical, bioethical and legal writing. This has led to overlooking wider but no less pertinent social, historical and cultural understandings about death. By ignoring the work of other social and clinical colleagues in the study of dying, the literature on the determination of death has become unnecessarily abstract and socially disconnected from parallel concerns about death and dying. This has led, and continues to lead to, incomplete suggestions and narrow discussions about the nature of death as well as an ongoing misunderstanding of general public and health care staff responses to brain death criteria. This paper provides a sociological outline of these problems through a review of the key literature on the determination of death. [Copyright &y& Elsevier]

Purpose: The completion of the Human Genome Project has resulted in increased epidemiological research to identify genes and their products as risk factors for adverse health events. A parallel increase in ethical issues associated with genetic research is noted. One such issue is whether or not epidemiologists should disclose individual genetic results to research participants. Existing ethical guidelines and frameworks are not helpful for determining whether disclosure is the moral choice. The purpose of this paper was to develop a framework for use by epidemiologists, research ethics boards, and institutional review boards during the protocol development stage to ethically address the dilemma regarding disclosure of individual genetic information. Methods: The core principles of research ethics were introduced and applied to the issues surrounding disclosure of genetic information. A principle-based framework was developed through analysis of the current ethical arguments for and against disclosure. Finally, examples demonstrating the use of the framework were provided. Conclusion: The proposed framework will not solve all ethical dilemmas related to individual disclosure of genetic information. It is, however, a useful starting point to facilitate the consideration process. [Copyright &y& Elsevier]

This paper analyses the e-discourse surrounding the dream of a Dutch scientist, Dr X, to create a human genetic databank in Bandung, Indonesia. Not only did Dr X hope to fulfil his dream of placing Indonesia on the genetic world map, he also aspired to set up the largest biomedical research centre in Indonesia, using blood samples gathered from various laboratories, medical centres and the jungle. His most important project was to study genes for familial syndromes, such as cancers and forms of mental retardation, some of which are considered to be specific for certain ethnic groups in Indonesia. Much has been written on the targets of the Human Genome Diversity Project (HGDP), but the incentives for and motives of geneticists to set up biobanks are little understood. Many works have 'framed' scientists as imperialists, Orientalists, racists and positivists or hailed them as explorers of humanity, pioneers of science and saviours of mankind. By analyzing Dr X's e-letters to fellow scientists, academics and politicians, I claim that the validity of such theories depends on whether they sufficiently take into account the institutional embedding. An institutional approach to biobanking should incorporate an assessment of socioeconomic inequalities, both on an international and national level, public healthcare needs, research regulation, and differences in academic cultures from a comparative perspective. [ABSTRACT FROM AUTHOR]

Abstract: The paper presents a web-based application, developed as a part of the Eurethnet database network, which is being used by project partners from EU New Member States to collect bibliographic records from bioethics domains. The application development was focused mainly on records compatibility with other Eurethnet databases, support for all European character sets, minimalisation of network traffic, and security issues. The time window available for the system development was very small and this problem was solved with our own software for automatic application generation. [Copyright &y& Elsevier]

Abstract: Scholars have long been interested in the relationship between the amount of consensus in an academic field and the amount of scholarly production. In this paper, I describe previous theory and research that suggest four possible relationships between the amount of scholarly production and the degree of consensus. These relationships are tested with data on the content of 50 sub-debates in the field of bioethics from 1973 to 1995. I find support for the conclusion that increased consensus leads to increased scholarly production. I conclude by discussing the implications of these findings for the humanities in general and bioethics in particular. [Copyright &y& Elsevier]

Abstract: Recent technologies and developments in neuroscience have contributed to remarkable scientific discoveries, and have also raised many new philosophical, ethical, legal, and social issues. Research in “neuroethics” has identified various ethical issues, which will be difficult for current biomedical ethics to resolve from both an experimental and a social perspective, such as criminal applications of brain scans, incidental findings during non-clinical brain imaging, and cognitive enhancement. Although American and European neuroscience societies have demonstrated immediate, concrete reactions to these ethical issues, including academic conferences, study programs, and publications, Japanese neuroscientists have so far produced little response. Ethics is tightly linked with one''s religion, nationality, culture, and social background, whereas science is tightly linked with the demand, economics, and politics of the society to which individuals belong. Taken together, it is important and necessary for Japanese neuroscientists to consider the ethical problems in Japanese neuroscience. In this paper, we first review the history of neuroethics in the world, and then report the less-developed ethical issues in the Japanese neuroscience community, focusing on neuroimaging and manipulative neuroscience as a first step in discussing how to apply principles in neuroethics to this rapidly progressing field of research. [Copyright &y& Elsevier]

Abstract: Since the inception of the Human Genome Project, human genetics has frequently been conducted through big science projects, combining academic, state and industrial methods, interests and resources. The legitimacy of such projects has been linked to national prestige and images of the nation, the purity of scientific endeavour, the entrepreneurial spirit, medical progress and the public health. A key complication in these discourses is that large-scale genetic research has yet to show major results when considered in terms of the objectives used to legitimate investment and social support for these projects. The main area showing promise at present is the developing field of pharmacogenetics, which is now attracting major industry and government investment. Sociological, ethical and philosophical study of human genetic sample-based research and pharmacogenetics has developed in parallel with inquiry in the biological and biomedical sciences. This paper introduces a symposium on the ethical and social aspects of this field of biomedical research. [Copyright &y& Elsevier]

Abstract: Assisted reproductive technologies are typically positioned as increasing the range of choices open to the healthcare consumer, thereby enhancing ‘reproductive freedom’. In this paper, we question the equivalence of reproductive choice and personal freedom in ethical theory, using results from a project investigating how lay people make ethical evaluations about the new genetic and reproductive technologies. We took the topic of social sex selection by preimplantation genetic diagnosis (PGD), and used group discussions and interviews in the north-east of England to trace how lay people develop and express their ethical evaluations, and to identify the implicit or explicit normative framework that gave rise to their opinions on prenatal sex selection. There was a striking level of ambivalence towards choice in general and reproductive choice in particular. Participants offered few positive statements and numerous reasons why reproductive choice might be problematic. Our participants’ argumentation shares with mainstream bioethical analysis the weighing of the possible harms of prenatal sex selection for social reasons against the harm of restricting reproductive freedom. However, unlike most secular–liberal bioethicists, many of our participants concluded that prenatal sex selection is undesirable because it is an expression of parental preference instead of a response to the future child''s need. Our interpretation of their reasoning is that they work from an ideal of “good parents”, one of the features of which is the relinquishing of control over their children, except to protect them from harm. This voluntary self-limitation does not indicate reduced autonomy, because parental autonomy can only operate within the limits set by this relational framework. We suggest that a model of relational autonomy captures our lay participants’ framing of the problem better than a more traditional understanding of autonomy. Our study also shows that in appropriately structured discussion of bioethical issues, lay people can articulate reasons for their opinions that are grounded in sophisticated and morally relevant concepts. [Copyright &y& Elsevier]

Abstract: The ‘informed consent’ process has been placed at the centre of bioethical and policy discourses about how the autonomy and rights of patients can best be protected. Although there has been critical analysis of how the process functions in relation to participation in research and particular ethical ‘dilemmas’, there has been little examination of the routine business of consenting to medical procedures. Evidence is now beginning to emerge that people may consent to surgery even when reluctant to do so. In this paper, we develop an analysis informed by Bourdieusian and interactionist social theory of the accounts of 25 British women who consented to surgery in obstetrics and gynaecology. Of these, nine were ambivalent or opposed to having an operation. When faced with a consent form, women''s accounts suggest that they rarely do anything other than obey professionals’ requests for a signature. Women''s capacity to act is reduced as they become enmeshed in the hospital structure of tacit, socially imposed rules of conduct. However, the interactionist account of power operating through the social rules of particular situated encounters, and the sanctions associated with rule-breaking, may not provide a sufficiently powerful explanation for why women submit to surgery they are opposed or ambivalent towards. Bourdieu''s concepts of habitus, capital and symbolic power/violence offer a potentially more elaborated account, by showing how the practical logic that women apply in the field of surgery confers a ‘sense of place’ relative to professionals. Women experience deficits in capital, intensified by their physical vulnerability in critical situations, that severely constrain their ability to exercise choice. This work demonstrates the weakness of the consent process as a safeguard of autonomy. Far from reinforcing autonomy, the process may reinforce rather than disrupt passivity, but more generally our findings raise the question of the extent to which autonomy is an illusory goal. [Copyright &y& Elsevier]