This paper proposes a refocusing of consent for clinical genetic testing, moving away from an emphasis on autonomy and information provision, towards an emphasis on the virtues of healthcare professionals seeking consent, and the relationships they construct with their patients. We draw on focus groups with UK healthcare professionals working in the field of clinical genetics, as well as in-depth interviews with patients who have sought genetic testing in the UK’s National Health Service. We explore two aspects of consent: first, (...) how healthcare professionals consider the act of ‘consenting’ patients; and second how these professional accounts, along with the accounts of patients, deepen our understanding of the consent process. Our findings suggest that while healthcare professionals working in genetic medicine put much effort into ensuring patients’ understanding about their impending genetic test, they acknowledge, and we show, that patients can still leave genetic consultations relatively uninformed. Moreover, we show how placing emphasis on the informational aspect of genetic testing is not always reflective of, or valuable to, patients’ decision-making. Rather, decision-making is socially contextualised – also based on factors outside of information provision. A more collaborative on-going consent process, grounded in virtue ethics and values of honesty, openness and trustworthiness, is proposed. (shrink)

Considerations of the notion of preparedness have come to the fore in the recent pandemic, highlighting a need to be better prepared to deal with sudden, unexpected and unwanted events. However, the concept of preparedness is also important in relation to planned for and desired interventions resulting from healthcare innovations. We describe ethical preparedness as a necessary component for the successful delivery of novel healthcare innovations, and use recent advances in genomic healthcare as an example. We suggest that practitioners and (...) organisations charged with delivering innovative and ambitious healthcare programmes can only succeed if they are able to exhibit the attribute of ethical preparedness. (shrink)

A personal reflection upon a career in medical ethics leads to four conclusions on what makes for 'good medical ethics'. Good medical ethics is practical in approach, philosophically well grounded, cross disciplinary, and while it might not be a necessary feature, the experience of the author suggests that it is the work of 'good people'.

This article reviews practitioners’ evaluations of in-hospital ethics seminars. A qualitative study included 11 innovative in-hospital ethics seminars, preceded and followed by interviews with most participants. The settings were obstetric, neonatal and haematology units in a teaching hospital and a district general hospital in England. Fifty-six health service staff in obstetric, neonatal, haematology, and related community and management services participated; 12 attended two seminars, giving a total of 68 attendances and 59 follow-up evaluation interviews. The 11 seminars facilitated by an (...) ethicist addressed the key local concerns of staff about the social and ethical consequences of advances in genetics and their impact on professional policies and practice. Seminar agendas were drawn from prior interviews with 70 staff members. During evaluation interviews, participants commented on general aspects that they had enjoyed, how the sessions could be improved, timing, the mix of participants, the quality of the facilitation, whether sessions should be more challenging, after-effects of sessions, and interest in attending seminars and contacting the ethicist in future. Participants valued the increased interprofessional understanding and coherent discussion of many pressing issues that addressed important though seldom discussed ethical questions. The seminars worked well in the different hospitals and specialties. (shrink)

This paper reports from an ongoing multidisciplinary, ethnographic study that is exploring the views, values and practices (the ethical frameworks) drawn on by professional staff in assisted conception units and stem cell laboratories in relation to embryo donation for research purposes, particularly human embryonic stem cell (hESC) research, in the UK. We focus here on the connection between possible incidental findings and the circumstances in which embryos are donated for hESC research, and report some of the uncertainties and dilemmas of (...) our staff participants. We explore the views of our study participants in relation to two themes: (1) rights to information and anticipating how donors might be informed about future research findings and (2) occupational work goals and trust. (shrink)

The UK’s 100,000 Genomes Project has the aim of sequencing 100,000 genomes from UK National Health Service (NHS) patients while concomitantly transforming clinical care such that whole genome sequencing becomes routine clinical practice in the UK. Policymakers claim that the project will revolutionize NHS care. We wished to explore the 100,000 Genomes Project, and in particular, the extent to which policymaker claims have helped or hindered the work of those associated with Genomics England – the company established by the Department (...) of Health to deliver the project. We interviewed 20 individuals linked to, or working for Genomics England. Interviewees had double-edged views about the context within which they were working. On the one hand, policymakers’ expectations attached to the venture were considered vacuous “genohype”; on the other hand, they were considered the impetus needed for those trying to advance genomic research into clinical practice. Findings should be considered for future genomes projects. (shrink)

BackgroundThe consent process for a genetic study is challenging when the research is conducted in a group stigmatized because of beliefs that the disease is familial. Podoconiosis, also known as 'mossy foot', is an example of such a disease. It is a condition resulting in swelling of the lower legs among people exposed to red clay soil. It is a very stigmatizing problem in endemic areas of Ethiopia because of the widely held opinion that the disease runs in families and (...) is untreatable. The aim of this study was to explore the impact of social stigma on the process of obtaining consent for a study on the genetics of podoconiosis in Southern Ethiopia.MethodsWe adapted a rapid assessment tool validated in The Gambia. The methodology was qualitative involving focus-group discussions (n = 4) and in-depth interviews (n = 25) with community members, fieldworkers, researchers and staff of the Mossy Foot Treatment and Prevention Association (MFTPA) working on prevention and treatment of podoconiosis.ResultsWe found that patients were afraid of participation in a genetic study for fear the study might aggravate stigmatization by publicizing the familial nature of the disease. The MFTPA was also concerned that discussion about the familial nature of podoconiosis would disappoint patients and would threaten the trust they have in the organization. In addition, participants of the rapid assessment stressed that the genetic study should be approved at family level before prospective participants are approached for consent. Based on this feedback, we developed and implemented a consent process involving community consensus and education of fieldworkers, community members and health workers. In addition, we utilized the experience and established trust of the MFTPA to diminish the perceived risk.ConclusionThe study showed that the consent process developed based on issues highlighted in the rapid assessment facilitated recruitment of participants and increased their confidence that the genetic research would not fuel stigma. Therefore, investigators must seek to assess and address risks of research from prospective participants' perspectives. This involves understanding the issues in the society, the culture, community dialogues and developing a consent process that takes all these into consideration. (shrink)

BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map (...) these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.ConclusionsWe believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large. (shrink)

Background Currently there is increasing recognition of the need for research in developing countries where disease burden is high. Understanding the role of local factors is important for undertaking ethical research in developing countries. We explored factors relating to information and communication during the process of informed consent, and the approach that should be followed for gaining consent. The study was conducted prior to a family-based genetic study among people with podoconiosis (non-filarial elephantiasis) in southern Ethiopia. Methodology/Principal Findings We adapted (...) a method of rapid assessment validated in The Gambia. The methodology was entirely qualitative, involving focus-group discussions and in-depth interviews. Discussions were conducted with podoconiosis patients and non-patients in the community, fieldworkers, researchers, staff of the local non-governmental organisation (NGO) working on prevention and treatment of podoconiosis, and community leaders. We found that the extent of use of everyday language, the degree to which expectations of potential participants were addressed, and the techniques of presentation of information had considerable impact on comprehension of information provided about research. Approaching podoconiosis patients via locally trusted individuals and preceding individual consent with community sensitization were considered the optimal means of communication. Prevailing poverty among podoconiosis patients, the absence of alternative treatment facilities, and participants' trust in the local NGO were identified as potential barriers for obtaining genuine informed consent. Conclusions Researchers should evaluate the effectiveness of consent processes in providing appropriate information in a comprehensible manner and in supporting voluntary decision-making on a study-by-study basis. (shrink)

The UK Chief Medical Officer’s 2016 Annual Report, Generation Genome, focused on a vision to fully integrate genomics into all aspects of the UK’s National Health Service. This process of integration, which has now already begun, raises a wide range of social and ethical concerns, many of which were discussed in the final Chapter of the report. This paper explores how the UK’s 100,000 Genomes Project —the catalyst for Generation Genome, and for bringing genomics into the NHS—is negotiating these ethical (...) concerns. The UK’s 100 kGP, promoted and delivered by Genomics England Limited, is an innovative venture aiming to sequence 100,000 genomes from NHS patients who have a rare disease, cancer, or an infectious disease. GEL has emphasised the importance of ethical governance and decision-making. However, some sociological critique argues that biomedical/technological organisations presenting themselves as ‘ethical’ entities do not necessarily reflect a space within which moral thinking occurs. Rather, the ‘ethical work’ conducted by organisations is more strategic, relating to the politics of the organisation and the need to build public confidence. We set out to explore whether GEL’s ethical framework was reflective of this critique, and what this tells us more broadly about how genomics is being integrated into the NHS in response to the ethical and social concerns raised in Generation Genome. We do this by drawing on a series of 20 interviews with individuals associated with or working at GEL. (shrink)

Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia.

_BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...) its likely impact. Studies must be scientifically valid; for research articles this includes a scientifically sound research question, the use of suitable methods and analysis, and following community-agreed standards relevant to the research field. Specific criteria for other article types can be found in the submission guidelines. _BMC series - open, inclusive and trusted_. (shrink)

Clinical practice and research are governed by distinct rules and regulations and have different approaches to, for example, consent and providing results. However, genomics is an example of where research and clinical practice have become codependent. The 100 000 genomes project is a hybrid venture where a person can obtain a clinical investigation only if he or she agrees to also participate in ongoing research—including research by industry and commercial companies. In this paper, which draws on 20 interviews with professional (...) stakeholders involved in 100kGP, we investigate the ethical issues raised by this project’s hybrid nature. While some interviewees thought the hybrid nature of 100kGP was its vanguard, interviewees identified several tensions around hybrid practice: how to decide who should be able to participate; how to determine whether offering results might unduly influence participation into wide-ranging but often as yet unknown research and how to ensure that patients/families do not develop false expectations about receiving results. These areas require further debate as 100kGP moves into routine healthcare in the form of the national genomic medicine service. To address the tensions identified, we explore the appropriateness of Faden et al.’s framework of ethical obligations for when research and clinical care are completely integrated. We also argue that enabling ongoing transparent and trustworthy communication between patients/families and professionals around the kinds of research that should be permitted in 100kGP will help to understand and ensure that expectations remain realistic. Our paper aims to encourage a focused discussion about these issues and to inform a new ‘social contract’ for research and clinical care in the health service. (shrink)

Background Rapid Ethical Assessment is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia. Methods Mixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health (...) researchers and regulators including ethics committee members in Ethiopian health research institutions and universities. Results In their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity, inadequate information, language barriers, cultural differences, undue expectations and power imbalances. About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed. Conclusion The study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders to address these gaps. Exploring further the feasibility and applicability of REA is recommended. (shrink)

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not following checklists; limited expertise (...) in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general. (shrink)

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not following checklists; limited expertise (...) in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general. (shrink)

This paper aims to make an empirically informed analytical contribution to the development of a more socially embedded bioethics. Drawing upon 10 interviews with cutting edge stem cell researchers (5 scientists and 5 clinicians) it explores and illustrates the ways in which the role positions of translational researchers are shaped by the ‘normative structures’ of science and medicine respectively and in combination. The empirical data is used to illuminate three overlapping themes of ethical relevance: what matters in stem cell research, (...) experimental treatment, and responsible claim making (as contrasted with ‘hype’. Finally, we suggest that this kind of ‘descriptive’ ethical analysis has potential relevance for understanding other substantive areas of stem cell ethics in practice, and we briefly consider the questions our analysis raises about role positions and ethical agency, and the implications for bioethics as a field of scholarship. (shrink)

Behavioral ecology, based in the theory of natural selection, predicts that certain behaviors are likely to differ consistently between the sexes in humans as well as other species: aggression, resource striving, information content of sexual signalling. These differences, though of course open to modification by cultural practice, arise because male and female humans, like males and females of other mammal species, typically optimize their reproductive lifetimes through different behaviors: males specializing in mating effort (which has a high fixed cost, and (...) is not offspring-specific), and females in parental effort (which has more linear reproductive returns, and is offspring-specific). The resulting patterns are reviewed. (shrink)

The history of research in American Indian/Alaska Native communities has been marked by unethical practices, resulting in mistrust and reluctance to participate in research. Harms are not l...

Emerging as an intersectional response to social inequalities perpetuated by the mainstream food movement in the United States, the food justice movement is being used by marginalized communities to address their food needs. This movement relies on an emancipatory discourse, illustrated by what I term intersectional agriculture. In many respects, the mainstream food movement reflects contention between marketization (corporate agriculture) and social protectionist (local food) discourses, while the role of food justice remains somewhat unclear as it relates to the mainstream (...) movement. Each movement attempts to restructure the ways in which food is distributed, consumed, and produced, impacting the social, cultural, political, economic, and environmental dimensions of food. Using the lens of Nancy Fraser’s triple movement framework, I construct an interpretation of food justice as the emancipatory pole of what I term the triple food movement to explore the role of food justice as it relates to the mainstream movement. Specifically, I draw upon the cases of black farmers and queer people in the U.S. creating and (re)creating spaces to address their community food needs and counter systems of domination constructed around race, class, gender, sexuality, agriculture, and food. (shrink)

Humanism and radical behaviorism are two of today's most anxiety-provoking systems of thought. While they have challenged some of society's most comforting notions, each has long been viewed as opposed to the other's practice of psychology. In this adversarial climate of contemporary psychology, Bobby Newman's compelling assessment in The Reluctant Alliance effectively tears down many of the ideological walls separating these two powerful schools of thought. He carefully researches the positions of both camps to dispel the myths that behaviorists are (...) "manipulators" and humanistic psychologists are "armchair philosophers". After examining both systems, Newman outlines their shared philosophical and historical roots and explores such questions as: How should psychotherapy be conducted? How is moral behavior created and maintained? Is behaviorism inherently unethical? What forms of education are most effective at imparting information and improving self-concepts? As Newman points out, "It is my intention to demonstrate that the differences between the two systems are not as great as they are made to seem. More importantly, I will suggest that each system contains flaws that can be corrected by combining elements of the other". After reading The Reluctant Alliance humanists will come to appreciate that behaviorism is not destructive determinism, and behaviorists will learn that much of what they hold to be true is a natural outgrowth of humanistic thought. (shrink)

We study the wisdom of the crowd in three sequential decision‐making tasks: the Balloon Analogue Risk Task (BART), optimal stopping problems, and bandit problems. We consider a behavior‐based approach, using majority decisions to determine crowd behavior and show that this approach performs poorly in the BART and bandit tasks. The key problem is that the crowd becomes progressively more extreme as the decision sequence progresses, because the diversity of opinion that underlies the wisdom of the crowd is lost. We also (...) consider model‐based approaches to each task. This involves inferring cognitive models for each individual based on their observed behavior, and using these models to predict what each individual would do in any possible task situation. We show that this approach performs robustly well for all three tasks and has the additional advantage of being able to generalize to new problems for which there are no behavioral data. We discuss potential applications of the model‐based approach to real‐world sequential decision problems and discuss how our approach contributes to the understanding of collective intelligence. (shrink)

Objective: To explore the ways in which health care practitioners working within the morally contested area of prenatal screening balance their professional and private moral values.Design: Qualitative study incorporating semistructured interviews with health practitioners followed by multidisciplinary discussion groups led by a health care ethicist.Setting: Inner city teaching hospital and district general hospital situated in South East England.Participants: Seventy practitioners whose work relates directly or indirectly to perinatal care.Results: Practitioners managed the interface between their professional and private moral values in (...) a variety of ways. Two key categories emerged: “tolerators”, and “facilitators”. The majority of practitioners fell into the “facilitator” category. Many “facilitators” felt comfortable with the prevailing ethos within their unit, and appeared unlikely to feel challenged unless the ethos was radically challenged. For others, the separation of personal and professional moral values was a daily struggle. In the “tolerator” group, some practitioners sought to influence the service offered directly, whereas others placed limits on how they themselves would contribute to practices they considered immoral.Conclusions: The “official” commitment to non-directiveness does not encourage open debate between professionals working in morally contested fields. It is important that practical means can be found to support practitioners and encourage debate. Otherwise, it is argued, these fields may come to be staffed by people with homogeneous moral views. This lack of diversity could lead to a lack of critical analysis and debate among staff about the ethos and standards of care within their unit. (shrink)

Women’s fertility is the focus of most demographic analyses, for in most mammals, and in many preindustrial societies, variance in male fertility, while an interesting biological phenomenon, is irrelevant. Yet in monogamous societies, the reproductive ecology of men, as well as that of women, is important is creating reproductive patterns. In nineteenth-century Sweden, the focus of this study, male reproductive ecology responded to resource conditions: richer men had more children than poorer men. Men’s fertility also interacted with local and historical (...) factors in complex ways to have significant impact on population growth. As a result, “the” demographic transition was local, and locally reversible, in Sweden. Results cannot be simply translated from nineteenth-century studies to current attempts to promote fertility decline, because today, male and female resource-fertility curves differ in shape, not only in magnitude. When we translate studies of fertility decline, it is important to study individual fertility and to discern whether, in any particular case, male and female patterns are similar. (shrink)

In their Noli me tangere images from the Northern Renaissance, Albrecht Dürer and Hans Holbein the Younger depict the encounter between Mary Magdalene and the risen Christ. They provide us images of the holy in humanity, and the human in the holy, in all their dimensions.

In their Noli me tangere images from the Northern Renaissance, Albrecht Dürer and Hans Holbein the Younger depict the encounter between Mary Magdalene and the risen Christ. They provide us images of the holy in humanity, and the human in the holy, in all their dimensions.

A common exhortation by conservationists suggests that we can solve ecological problems by returning to the attitudes of traditional societies: reverence for resources, and willingness to assume short-term individual costs for long-term, group-beneficial sustainable management. This paper uses the 186-society Standard Cross-Cultural Sample to examine resource attitudes and practices. Two main findings emerge: (1) resource practices are ecologically driven and do not appear to correlate with attitude (including sacred prohibition) and (2) the low ecological impact of many traditional societies results (...) not from conscious conservation efforts, but from various combinations of low population density, inefficient extraction technology, and lack of profitable markets for extracted resources. (shrink)

The structuralist approach represents the relation between a model and physical system as a relation between two mathematical structures. However, since a physical system is _prima facie_ _not_ a mathematical structure, the structuralist approach seemingly fails to represent the fact that science is about concrete, physical reality. In this paper, I take up this _problem of lost reality_ and suggest how it may be solved in a purely structuralist fashion. I start by briefly introducing both the structuralist approach and the (...) problem of lost reality and discussing the various (non-structuralist) solutions that have been proposed in the literature. Following this, I decompose the problem into the _ontological mismatch_ and _specification_ problems. In response to the former, I present a _metascientific dissolution argument_, according to which the difference in kind between mathematical structures and physical systems poses no deep obstacle to the structuralist approach, and consider some upshots of this argument for our views on representation. By way of conclusion, I argue that the metascientific dissolution argument paves the way for a solution to the specification problem as well. (shrink)

The project of integrated HPS has occupied philosophers of science in one form or another since at least the 1960s. Yet, despite this substantial interest in bringing together philosophical and historical reflections on the nature of science, history of science and formal philosophy of science remain as divided as ever. In this paper, I will argue that the continuing separation between historical and formal philosophy of science is ill-founded. I will argue for this in both abstract and concrete terms. At (...) the abstract level, I reconstruct two possible arguments for the incompatibility of historical and formal philosophy of science and argue that they are both wanting. At the concrete level, I discuss how historical and formal philosophy of science have been brought together in practice, namely: in the form of a largely forgotten research tradition that I will refer to here as the study of formalized macro-units. After a brief exposition, I argue that this research tradition has been unduly overlooked by historically minded philosophers of science. Bringing together these observations, I argue that the divide between historical and formal philosophy of science is not grounded in any substantive arguments, but can be primarily attributed to disciplinary happenstance. (shrink)