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

Background Patient advocacy organizations (PAOs) have an increasing influence on health policy and biomedical research, therefore, questions about the specific character of their responsibility arise: Can PAOs bear moral responsibility and, if so, to whom are they responsible, for what and on which normative basis? Although the concept of responsibility in healthcare is strongly discussed, PAOs particularly have rarely been systematically analyzed as morally responsible agents. The aim of the current paper is to analyze the character of PAOs’ responsibility to provide guidance to themselves and to other stakeholders in healthcare. Methods Responsibility is presented as a concept with four reference points: (1) The subject, (2) the object, (3) the addressee and (4) the underlying normative standard. This four-point relationship is applied to PAOs and the dimensions of collectivity and prospectivity are analyzed in each reference point. Results Understood as collectives, PAOs are, in principle, capable of intentionality and able to act and, thus, fulfill one prerequisite for the attribution of moral responsibility. Given their common mission to represent those affected, PAOs can be seen as responsible for patients’ representation and advocacy, primarily towards a certain group but secondarily in a broader social context. Various legal and political statements and the bioethical principles of justice, beneficence and empowerment can be used as a normative basis for attributing responsibility to PAOs. Conclusions The understanding of responsibility as a four-point relation incorporating collective and forward-looking dimensions helps one to understand the PAOs’ roles and responsibilities better. The analysis, thus, provides a basis for the debate about PAOs’ contribution and cooperation in the healthcare sector.

Background Health screening is undertaken to identify individuals who are deemed at higher risk of disease for further diagnostic testing so that they may possibly benefit from interventions to modify the natural course of disease. In Singapore, screening tests are widely available in the form of a package, which bundles multiple tests in one session and commonly includes non-recommended tests. There are various ethical issues associated with such testing as they may not be clinically appropriate and can result in more harm than benefit. This article describes the practice of health screening packages, identifies the ethical issues arising from such packages and discusses the implications of these ethical issues on policy and practice of screening in Singapore. Methods A content analysis of the websites of providers offering general health screening packages to individuals was conducted. A total of 14 health screening package providers were analysed for how packages were conducted and promoted, how clinically appropriate screening tests were, and the price range and composition of screening packages. A normative ethical analysis based on the four principles approach of beneficence, non-maleficence, autonomy and justice in biomedical ethics was used. Results Twelve of the 14 providers included non-recommended tests such as tumour markers, treadmill stress tests and MRI scans in their general health screening packages. Package prices ranged from S$26 to S$10,561, with providers charging higher when more tests were included. Health screening packages were broadly conducted in three stages: (1) the offer and selection of a health screening package; (2) medical assessment and performance of screening tests; (3) a post-screening review. While material provided by all providers was factual, there was no information on the potential risks or harms of screening. Conclusion Several ethical issues were identified that should be addressed with regard to health screening packages in Singapore. A key issue was the information gap between providers and patients, which may result in patients undergoing inappropriate testing that may be more harmful than beneficial. Health screening packages can stimulate unnecessary demand for healthcare and contribute to an inequitable distribution of healthcare resources.

Background In the pandemic time, many low- and middle-income countries are experiencing restricted access to COVID-19 vaccines. Access to imported vaccines or ways to produce them locally became the principal source of hope for these countries. But developing a strategy for success in obtaining and allocating vaccines was not easy task. The governments in those countries have faced the difficult decision whether to accept or reject offers of vaccine diplomacy, weighing the price and availability of COVID-19 vaccines against the concerns over their efficacy and safety. We aimed to analyze public opinion regarding the governmental strategies to obtain COVID-19 vaccines in three Central Asian countries, focusing particularly on possible ethical issues. Methods We searched for opinions expressed either in Russian or in the respective national languages. We provided data on the debate within three countries, drawn from social media postings and other sources. The opinion data was not restricted by source and time. This allowed collecting a wide range of possible opinions that could be expressed regarding COVID-19 vaccine supply and human participation in the vaccine trial. We recognized ethical issues and possible questions concerning different ethical frameworks. We also considered scientific data and other information, in the process of reasoning. Results As a result, public views on their respective government policies on COVID-19 vaccine supply ranged from strongly negative to slightly positive. We extracted the most important issues from public debates, for our analysis. The first issue involved trade-offs between quantity, speed, price, freedom, efficacy, and safety in the vaccines. The second set of issues arose in connection with the request to site a randomized trial in one of the countries (Uzbekistan). After considering additional evidence, we weighed individual and public risks against the benefits to make specific judgements concerning every issue. Conclusions We believe that our analysis would be a helpful example of solving ethical issues that can arise concerning COVID-19 vaccine supply around the world. The public view can be highly critical, helping to spot such issues. An ignoring this view can lead to major problems, which in turn, can become a serious obstacle for the vaccine coverage and epidemics’ control in the countries and regions.

Background Genetic testing is moving from targeted investigations of monogenetic diseases to broader testing that may provide more information. For example, recent health economic studies of genetic testing for an increased risk of breast cancer suggest that it is associated with higher cost-effectiveness to screen for pathogenic variants in a seven gene panel rather than the usual two gene test for variants in BRCA1 and BRCA2. However, irrespective of the extent to which the screening of the panel is cost-effective, there may be ethical reasons to not screen for pathogenic variants in a panel, or to revise the way in which testing and disclosing of results are carried out. Main text In this paper we discuss the ethical aspects of genetic testing for an increased risk of breast cancer with a special focus on the ethical differences between screening for pathogenic variants in BRCA1/2 and a seven gene panel. The paper identifies that the panel increases the number of secondary findings as well as the number of variants of uncertain significance as two specific issues that call for ethical reflection. Conclusions We conclude that while the problem of handling secondary findings should not be overstated with regard to the panel, the fact that the panel also generate more variants of uncertain significance, give rise to a more complex set of problems that relate to the value of health as well as the value of autonomy. Therefore, it is insufficient to claim that the seven gene panel is preferable by only referring to the higher cost effectiveness of the panel.

Background Advance research directives (ARD) have been suggested as a means by which to facilitate research with incapacitated subjects, in particular in the context of dementia research. However, established disclosure requirements for study participation raise an ethical problem for the application of ARDs: While regular consent procedures call for detailed information on a specific study (“token disclosure”), ARDs can typically only include generic information (“type disclosure”). The introduction of ARDs could thus establish a double standard in the sense that within the context of ARDs, type disclosure would be considered sufficient, while beyond this context, token disclosure would remain necessary. Main body This paper provides an ethical analysis of ARDs, taking into account the results of numerous empirical studies that have been performed so far. It will be argued that a revised understanding of informed consent can allow for context-sensitive disclosure standards. As a consequence, ARDs that include type disclosure can be acceptable under suitable circumstances. Such an approach raises a number of objections. A thorough examination shows, however, that they are not sufficient to justify a rejection of the approach. Conclusion The approach presented in this paper avoids introducing a double standard. It is, therefore, more suitable for the implementation of ARDs than established approaches.

Background The expectation of pandemic-induced severe resource shortages has prompted authorities to draft and update frameworks to guide clinical decision-making and patient triage. While these documents differ in scope, they share a utilitarian focus on the maximization of benefit. This utilitarian view necessarily marginalizes certain groups, in particular individuals with increased medical needs. Main body Here, we posit that engagement with the disability critique demands that we broaden our understandings of justice and fairness in clinical decision-making and patient triage. We propose the capabilities theory, which recognizes that justice requires a range of positive capabilities/freedoms conducive to the achievement of meaningful life goals, as a means to do so. Informed by a disability rights critique of the clinical response to the pandemic, we offer direction for the construction of future clinical triage protocols which will avoid ableist biases by incorporating a broader apprehension of what it means to be human. Conclusion The clinical pandemic response, codified across triage protocols, should embrace a form of justice which incorporates a vision of pluralistic human capabilities and a valuing of positive freedoms.

BackgroundOur human societies and certainly also (bio) medicine are more and more permeated with technology. There seems to be an increasing awareness among bioethicists that an effective and comprehensive approach to ethically guide these emerging biomedical innovations into society is needed. Such an approach has not been spelled out yet for bioethics, while there are frequent calls for ethical guidance of biomedical innovation, also by biomedical researchers themselves. New and emerging biotechnologies require anticipation of possible effects and implications, meaning the scope is not evaluative after a technology has been fully developed or about hypothetical technologies, but real-time for a real biotechnology.Main textIn this paper we aim to substantiate and discuss six ingredients that we increasingly see adopted by ethicists and that together constitute “ethics parallel research”. This approach allows to fulfil two aims: guiding the development process of technologies in biomedicine and providing input for the normative evaluation of such technologies. The six ingredients of ethics parallel research are: (1) disentangling wicked problems, (2) upstream or midstream ethical analysis, (3) ethics from within, (4) inclusion of empirical research, (5) public participation and (6) mapping societal impacts, including hard and soft impacts. We will draw on gene editing, organoid technology and artificial intelligence as examples to illustrate these six ingredients.ConclusionEthics parallel research brings together these ingredients to ethically analyse and proactively or parallel guide technological development. It widens the roles and judgements from the ethicist to a more anticipatory and constructively guiding role. Ethics parallel research is characterised by a constructive, rather than a purely critical perspective, it focusses on developing best-practices rather than outlining worst practice, and draws on insights from social sciences and philosophy of technology.

BackgroundAs Next Generation Sequencing technologies are increasingly implemented in biomedical research and (translational) care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice.MethodsIn a first step we clarify some central concepts such as “raw data”; in a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one’s raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data.ResultsIn several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom.ConclusionTaking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects’ legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations.

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

Background Starting dialysis at an advanced age is a clinical challenge and an ethical dilemma. The advantages of starting dialysis at “extreme” ages are questionable as high dialysis-related morbidity induces a reflection on the cost- benefit ratio of this demanding and expensive treatment in a person that has a short life expectancy. Where clinical advantages are doubtful, ethical analysis can help us reach decisions and find adapted solutions. Case presentation Mr. H is a ninety-year-old patient with end-stage kidney disease that is no longer manageable with conservative care, in spite of optimal nutritional management, good blood pressure control and strict clinical and metabolic evaluations; dialysis is the next step, but its morbidity is challenging. The case is analysed according to principlism (beneficence, non-maleficence, justice and respect for autonomy). In the setting of care, dialysis is available without restriction; therefore the principle of justice only partially applied, in the absence of restraints on health-care expenditure. The final decision on whether or not to start dialysis rested with Mr. H (respect for autonomy). However, his choice depended on the balance between beneficence and non-maleficence. The advantages of dialysis in restoring metabolic equilibrium were clear, and the expected negative effects of dialysis were therefore decisive. Mr. H has a contraindication to peritoneal dialysis (severe arthritis impairing self-performance) and felt performing it with nursing help would be intrusive. Post dialysis fatigue, poor tolerance, hypotension and intrusiveness in daily life of haemodialysis patients are closely linked to the classic thrice-weekly, four-hour schedule. A personalized incremental dialysis approach, starting with one session per week, adapting the timing to the patient’s daily life, can limit side effects and “dialysis shock”. Conclusions An individualized approach to complex decisions such as dialysis start can alter the delicate benefit/side-effect balance, ultimately affecting the patient’s choice, and points to a narrative, tailor-made approach as an alternative to therapeutic nihilism, in very old and fragile patients.

Background There is growing interest in the use and incorporation of empirical data in bioethics research. Much of the recent focus has been on specific “empirical bioethics” methodologies, which attempt to integrate the empirical and the normative. Researchers in the field are, however, beginning to explore broader questions, including around acceptable standards of practice for undertaking such research. The framework: In this article, we further widen the focus to consider the overall shape of an empirical bioethics research project. We outline a framework that identifies three key phases of such research, which are conveyed via a landscaping metaphor of Mapping-Framing-Shaping. First, the researcher maps the field of study, typically by undertaking literature reviews. Second, the researcher frames particular areas of the field of study, exploring these in depth, usually via qualitative research. Finally, the researcher seeks to (re-)shape the terrain by issuing recommendations that draw on the findings from the preceding phases. To qualify as empirical bioethics research, the researcher will utilise a methodology that seeks to bridge these different elements in order to arrive at normative recommendations. We illustrate the framework by citing examples of diverse projects which broadly adopt the three-phase framework. Amongst the strengths of the framework are its flexibility, since (as the examples indicate) it does not prescribe any specific methods or particular bridging methodology. However, the framework might also have its limitations, not least because it appears particularly to capture projects that involve qualitative – as opposed to quantitative – research. Conclusions Despite its possible limitations, we offer the Mapping-Framing-Shaping framework in the hope that this will prove useful to those who are seeking to plan and undertake empirical bioethics research projects.

Background Animal models of human diseases are often used in biomedical research in place of human subjects. However, results obtained by animal models may fail to hold true for humans. One way of addressing this problem is to make animal models more similar to humans by placing human tissue into animal models, rendering them chimeric. Since technical and ethical limitations make neurological disorders difficult to study in humans, chimeric models with human neural tissue could help advance our understanding of neuropathophysiology. Main body In this article, we examine whether the introduction of human neural tissue and any consequent cognitive change is relevant to the way we ought to treat chimeras. We argue that changes in cognitive abilities are morally relevant to the extent that they increase the capacities that affect the moral status of any entity, including awareness, autonomy, and sociability. We posit that no being, regardless of species, should be treated in a way that is incommensurate with its moral status. Finally, we propose a framework that can be used to guide ethical assessment of research involving chimeras with advanced cognitive capacities. Conclusion We advance this framework as a useful tool for bringing relevant considerations to the forefront for those considering the ethical merit of proposed chimeric research. In doing so, we examine concepts relevant to the question of how any entity may be treated, including moral status, dignity, and capacities.

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

Background There is a gap between health economic evaluation methods and the value judgments of coverage decision makers, at least in Germany. Measuring preference satisfaction has been claimed to be inappropriate for allocating health care resources, e.g. because it disregards medical need. The existing methods oriented at medical need have been claimed to disregard non-consequentialist fairness concerns. The aim of this article is to propose a new, contractarian argument for justifying needs-based economic evaluation. It is based on consent rather than maximization of some impersonal unit of value to accommodate the fairness concerns. Main text This conceptual paper draws upon contractarian ethics and constitution economics to show how economic evaluation can be viewed as an institution to overcome societal conflicts in the allocation of scarce health care resources. For this, the problem of allocating scarce health care resources in a society is reconstructed as a social dilemma. Both disadvantaged patients and affluent healthy individuals can be argued to share interests in a societal contract to provide technologies which ameliorate medical need, based on progressive funding. The use of needs-based economic evaluation methods for coverage determination can be interpreted as institutions for conflict resolution as far as they use consented criteria to ensure the social contract’s sustainability and avoid implicit rationing or unaffordable contribution rates. This justifies the use of needs-based evaluation methods by Pareto-superiority and consent (rather than by some needs-based value function per se). Conclusion The view of economic evaluation presented here may help account for fairness concerns in the further development of evaluation methods. This is because it directs the attention away from determining some unit of value to be maximized towards determining those persons who are most likely not to consent and meeting their concerns. Following this direction in methods development is likely to increase the acceptability of health economic evaluation by decision makers.

Background Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine (FM) of University Eduardo Mondlane (UEM) and the Maputo Central Hospital (MCH) established a joint Institutional Committee on Bioethics for Health (CIBS FM & MCH). This study examines the experience of the first 4 years of the CIBS FM & MCH. Methods This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee’s respective reviews and actions. Results A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master’s degree research (42%). Descriptive cross-sectional studies were the most frequently reviewed research (61%). The majority were prospective (71%) and used quantitative methodologies (51%). The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS’s average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS. Conclusions Our results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training and ethical capacity building for CIBS across the country continue to be needed, as Mozambique develops greater capacity for research and makes progress toward improving the health of all its citizens.

Background With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice (GCP) and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise. Therefore, we developed a simple auditing process (a screening audit) and evaluated its feasibility and effectiveness. Methods The screening audit was developed using a routine audit checklist based on the Severance Hospital’s Human Research Protection Program policies and procedures. The measure includes 20 questions, and results are summarized in five categories of audit findings. We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 2013 and 2017. We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. Results Investigator reply rates gradually increased, except for the first year (73% → 26% → 53% → 49% → 55%). The studies were graded as “critical,” “major,” “minor,” and “not a finding” (11.9, 39.0, 42.9, and 6.3%, respectively), based on findings and number of deficiencies. The auditors’ decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. Low-risk level studies, single center studies, and non-phase clinical research showed more prevalent frequencies of being “major” or “critical” (p = 0.002

Background Patients in a vegetative state/ unresponsive wakefulness syndrome (VS/UWS) pose ethical dilemmas to those involved. Many conflicts occur between professionals and families of these patients. In the Netherlands physicians are supposed to withdraw life sustaining treatment once recovery is not to be expected. Yet these patients have shown to survive sometimes for decades. The role of the families is thought to be important. The aim of this study was to make an inventory of the professional perspective on conflicts in long-term care of patients in VS/UWS. Methods A qualitative study of transcripts on 2 Moral Deliberations (MD’s) in 2 cases of patients in VS/UWS in long-term care facilities. Results Six themes emerged: 1) Vision on VS/UWS; 2) Treatment and care plan; 3) Impact on relationships; 4) Feelings/attitude; 5) Communication; 6) Organizational aspects. These themes are related to professionals and to what families had expressed to the professionals. We found conflicts as well as contradictory feelings and thoughts to be a general feature in 4 of these themes, both in professionals and families. Conflicts were found in several actors: within families concerning all 6 themes, in nurse teams concerning the theme treatment and care plan, and between physicians concerning all 6 themes. Conclusions Different visions, different expectations and hope on recovery, deviating goals and contradictory feelings/thoughts in families and professionals can lead to conflicts over a patient with VS/UWS. Key factors to prevent or solve such conflicts are a carefully established diagnosis, clarity upon visions, uniformity in treatment goals and plans, an open and empathic communication, expertise and understanding the importance of contradictory feelings/thoughts. Management should bridge conflicts and support their staff, by developing expertise, by creating stability and by facilitating medical ethical discourses. Shared compassion for the patient might be a key to gain trust and bridge the differences from non-shared to shared decision making.

Background Internationally, clinical ethics support has yet to be implemented systematically in community health and care services. A large-scale Norwegian project (2007–2015) attempted to increase ethical competence in community services through facilitating the implementation of ethics support activities in 241 Norwegian municipalities. The article describes the ethics project and the ethics activities that ensued. Methods The article first gives an account of the Norwegian ethics project. Then the results of two online questionnaires are reported, characterizing the scope, activities and organization of the ethics activities in the Norwegian municipalities and the ethical topics addressed. Results One hundred and thirty-seven municipal contact persons answered the first survey (55 % response rate), whereas 217 ethics facilitators from 48 municipalities responded to the second (33 % response rate). The Norwegian ethics project is vast in scope, yet has focused on some institutions and professions (e.g., nursing homes, home-based care; nurses, nurses’ aides, unskilled workers) whilst seldom reaching others (e.g., child and adolescent health care; physicians). Patients and next of kin were very seldom involved. Through the ethics project employees discussed many important ethical challenges, in particular related to patient autonomy, competence to consent, and cooperation with next of kin. The “ethics reflection group” was the most common venue for ethics deliberation. Conclusions The Norwegian project is the first of its kind and scope, and other countries may learn from the Norwegian experiences. Professionals have discussed central ethical dilemmas, the handling of which arguably makes a difference for patients/users and service quality. The study indicates that large (national) scale implementation of CES structures for the municipal health and care services is complex, yet feasible.

Background Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study within which the Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. PEARL incorporated qualitative research to seek the views of young people about data linkage, including their opinions about appropriate safeguards and research governance. In this paper we focus on views expressed about the purpose and composition of research ethics committees. Methods Digitally recorded interviews were conducted with 48 participants aged 17–19 years. Participants were asked about whether medical research should be monitored and controlled, their knowledge of research ethics committees, who should sit on these committees and what their role should be. Interview recordings were fully transcribed and anonymised. Thematic analysis was undertaken, assisted by the Framework approach to data management. Results The majority of interviewees had little or no specific knowledge of ethics committees. Once given basic information about research ethics committees, only three respondents suggested there was no need for such bodies to scrutinise research. The key tasks of ethics committees were identified as monitoring the research process and protecting research participants. The difficulty of balancing the potential to inhibit research against the need to protect research participants was acknowledged. The importance of relevant research and professional expertise was identified but it was also considered important to represent wider public opinion, and to counter the bias potentially associated with self-selection possibly through a selection process similar to ‘jury duty’. Conclusions There is a need for more education and public awareness about the role and composition of research ethics committees. Despite an initial lack of knowledge, interviewees were able to contribute their ideas and balance the rights of individuals with the wider benefits from research. The suggestion that public opinion should be represented through random selection similar to jury duty may be worth pursuing in the light of the need to ensure diversity of opinion and establish trust amongst the general public about the use of ‘big data’ for the wider public good.

Background Moral case deliberation (MCD) as a form of clinical ethics support is usually implemented in health care institutions and educational programs. While there is no previous research on the use of clinical ethics support on the level of health care regulation, employees of regulatory bodies are regularly confronted with moral challenges. This pilot study describes and evaluates the use of MCD at the Dutch Health Care Inspectorate (IGZ). The objective of this pilot study is to investigate: 1) the current way of dealing with moral issues at the IGZ; 2) experience with and evaluation of MCD as clinical ethics support, and 3) future preferences and (perceived) needs regarding clinical ethics support for dealing with moral questions at the IGZ. Methods We performed an explorative pilot study. The research questions were assessed by means of: 1) interviews with MCD participants during four focus groups; and 2) interviews with six key stakeholders at the IGZ. De qualitative data is illustrated by data from questionnaires on MCD outcomes, perspective taking and MCD evaluation. Results Professionals do not always recognize moral issues. Employees report a need for regular and structured moral support in health care regulation. The MCD meetings are evaluated positively. The most important outcomes of MCD are feeling secure and learning from others. Additional support is needed to successfully implement MCD at the Inspectorate. Conclusion We conclude that the respondents perceive moral case deliberation as a useful form of clinical ethics support for dealing with moral questions and issues in health care regulation.

Background: Continuous deep sedation at the end of life is a practice that has been the topic of considerable ethical debate, for example surrounding its perceived similarity or dissimilarity with physician-assisted dying. The practice is generally considered to be legal as a form of symptom control, although this is mostly only assumed. France has passed an amendment to the Public Health Act that would grant certain terminally ill patients an explicit right to continuous deep sedation until they pass away. Such a framework would be unique in the world. Discussion: In this paper we will highlight and reflect on four relevant aspects and shortcomings of the proposed bill. First, that the bill suggests that continuous deeps sedation should be considered as a sui generis practice. Second, that it requires that sedation should always be accompanied by the withholding of all artificial nutrition and hydration. In the most recently amended version of the legal proposal it is stated that life sustaining treatments are withheld unless the patient objects. Third, that the French bill would not require that the suffering for which continuous deep sedation is initiated is unbearable. Fourth, the question as to whether the proposal should be considered as a way to avoid having to decriminalise euthanasia and/or PAS or, on the contrary, as a veiled way to decriminalise these practices. Summary: The French proposal to amend the Public Health Act to include a right to continuous deep sedation for some patients is a unique opportunity to clarify the legality of continuous deep sedation as an end-of-life practice. Moreover, it would recognize that the practice of continuous deep sedation raises ethical and legal issues that are different from those raised by symptom control on the one hand and assisted dying on the other hand. Nevertheless, there are still various issues of significant ethical concern in the French legislative proposal.

Background Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity of literature which connects the normative debate about justifications for different consent models with findings gained in empirical research. In this paper we discuss findings of a limited review of socio-empirical research on patients’ and healthy research participants’ experiences and views regarding consent to biobank research in light of ethical principles for appropriate information and consent. Methods Review question: Which empirical data are available on research participants’ perceptions and views regarding information and elicitation of consent for biobank research? Search of articles published till March 1st 2014 in Pubmed. Review of abstracts and potentially relevant full text articles by two authors independently. As categories for content analysis we defined (i) understanding or recall of information, (ii) preferences regarding information or consent, and (iii) research participants’ concerns. Results The search in Pubmed yielded 337 abstracts of which 10 articles were included in this study. Approaches to information and consent varied considerably across the selected studies. The majority of research participants opted for some version of limited consent when being informed about such possibility. Among the factors influencing the type of preferred consent were information about sponsoring of biobank research by pharmaceutical industry and participants’ trade-off between privacy and perceived utility. Studies investigating research participants’ understanding and recall regarding the consent procedure indicated considerable lack of both aspects. Research participants’ perceptions of benefits and harms differ across those studies. Conclusion The knowledge, perceptions and views of research participants who have undergone a consent procedure within the context of biobank research raise several questions on the issue of how to inform and elicit consent in an ethically acceptable way. In our empirical-ethical analysis we develop suggestions on how the practice of eliciting consent in the biobank context should be improved.

Background Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claims that placebo-controlled surgical trials are inherently unethical. On the other hand, without placebo-controlled surgical trials, it may be impossible to know whether an apparent benefit from surgery is due to the intervention itself or to the placebo effect. Discussion In this paper we investigate justifications for placebo-controlled surgical trials and suggest three measures for strengthening their ethical acceptability. We argue that, given the extent, irreversibility and cost of surgical interventions, there is a need for the best possible evidence about their efficacy. In some cases, the strongest evidence will be from placebo-controlled surgical trials, especially where interventions are for outcomes (such as pain) that are likely to elicit a placebo response. In the second part of the paper, we propose three specific measures to increase the ethical acceptability of placebo-controlled surgical trials. The first is structured consultation with the relevant patient community about the risks and benefits of particular placebo-controlled surgical trials. The second seeks to address the therapeutic misconception through the use of educational materials, informed by patient consultation. Finally, we argue for ethical consideration of non-surgeon clinicians who are necessarily involved in the delivery of placebo-surgical interventions. Summary If there is no appropriate surgical comparator and the risks can be reduced to the absolute minimum (given the type of placebo procedure required), and the research has the support of the relevant patient community, there may be grounds for judging that the potential benefits of specific placebo-controlled surgical trials outweigh the risks. If so justified, the ethical acceptability of placebo-controlled surgical trials can be enhanced through using educational measures to address participant vulnerability, and by recognizing clinicians who are necessary participants in the research.

Background Translational research in medicine requires researchers to identify the steps to transfer basic scientific discoveries from laboratory benches to bedside decision-making, and eventually into clinical practice. On a parallel track, philosophical work in ethics has not been obliged to identify the steps to translate theoretical conclusions into adequate practice. The medical ethicist A. Cribb suggested some years ago that it is now time to debate ‘the business of translational’ in medical ethics. Despite the very interesting and useful perspective on the field of medical ethics launched by Cribb, the debate is still missing. In this paper, I take up Cribb’s invitation and discuss further analytic distinctions needed to base an ethics aiming to translate between theory and practice. Discussion The analytic distinctions needed to base an ethics aiming to translate between theory and practice are identified as ‘movements of translation’. I explore briefly what would constitute success and limitations to these intended translational movements by addressing the challenges of the epistemological gap between philosophical and practical ethics. The categories of translational movements I suggest can serve as a starting point for a systematic, collective self-inspection and discussion of the merits and limitations of the various academic and practical activities that bioethicists are engaged in. I further propose that translational ethics could be considered as a new discipline of ethical work constructively structured around compositions of translational movements. Summary Breaking the idea of translational ethics into distinct translational movements provide us with a nuanced set of conditions to explore and discuss the justification and limitations of various efforts carried out in the field of bioethics. In this sense, the proposed framework could be a useful vehicle for augmented collective, self-reflexivity among both philosophers and practitioners who are ‘doing bioethics’. Also, carefully designed, overall approaches combining justified, self-reflexive philosophical and practical efforts according to the suggested distinctions could be expected to realise – or at least improve a facilitation of – translation of ethics across the theory-practice gap.

Background: In Japan, people are negative towards life-prolonging treatments. Laws that regulate withholding or discontinuing life-prolonging treatments and advance directives do not exist. Physicians, however, view discontinuing life-prolonging treatments negatively due to fears of police investigations. Although ministerial guidelines were announced regarding the decision process for end-of-life care in 2007, a consensus could not be reached on the definition of end-of-life and conditions for withholding treatment. We established a forum for extended discussions and consensus building on this topic. Methods: We used the Neo-Socratic Dialogue (NSD) method which promotes philosophical discussion based on a case-study to address a question and formulate a consensus and answer in a group. The question chosen for the dialogue was: “What is a life-prolonging treatment?” A series of dialogues took place over a period of one and a half days. It was carried out by three groups in 2010 and 2011. Seven participants with diverse backgrounds were recruited per group. We analyzed the content of the discussion. Results: Based on three case studies concerning different opinions about treatment options for an older dementia patient, a patient demanding chemotherapy, and a severely ill neonate, conditions for futile life-prolonging treatment were elucidated through NSD. Such treatments are those carried out for the sole purpose of prolonging life and are detrimental to the patient, and should be decided based foremost on the patient’s lack of desire for treatment, the consensus of those involved, and through social acceptance. These arguments are essentially consistent with ones on medical futility in the United States. By expressing the objective of healthcare and the requirement of social acceptance, participants were also able to elucidate issues related to the awareness of those involved and the medical environment. Compared to the end-of-life guidelines in Japan, the objective of treatment, its effects, and benefits were more specifically discussed with the patient’s intentions as the foremost consideration, rather than being limited to the terminal stage. Conclusions: This small study contributed to elucidating the conditions and current problems of futile life-prolonging treatment through NSD. They would suggest more substantial guidelines and improvements on the administration of the treatment.

Background: Medical tourism—the practice where patients travel internationally to privately access medical care— may limit patients’ regular physicians’ abilities to contribute to the informed decision-making process. We address this issue by examining ways in which Canadian family doctors’ typical involvement in patients’ informed decisionmaking is challenged when their patients engage in medical tourism. Methods: Focus groups were held with family physicians practicing in British Columbia, Canada. After receiving ethics approval, letters of invitation were faxed to family physicians in six cities. 22 physicians agreed to participate and focus groups ranged from two to six participants. Questions explored participants’ perceptions of and experiences with medical tourism. A coding scheme was created using inductive and deductive codes that captured issues central to analytic themes identified by the investigators. Extracts of the coded data that dealt with informed decision-making were shared among the investigators in order to identify themes. Four themes were identified, all of which dealt with the challenges that medical tourism poses to family physicians’ abilities to support medical tourists’ informed decision-making. Findings relevant to each theme were contrasted against the existing medical tourism literature so as to assist in understanding their significance. Results: Four key challenges were identified: 1) confusion and tensions related to the regular domestic physician’s role in decision-making; 2) tendency to shift responsibility related to healthcare outcomes onto the patient because of the regular domestic physician’s reduced role in shared decision-making; 3) strains on the patient-physician relationship and corresponding concern around the responsibility of the foreign physician; and 4) regular domestic physicians’ concerns that treatments sought abroad may not be based on the best available medical evidence on treatment efficacy. Conclusions: Medical tourism is creating new challenges for Canadian family physicians who now find themselves needing to carefully negotiate their roles and responsibilities in the informed decision-making process of their patients who decide to seek private treatment abroad as medical tourists. These physicians can and should be educated to enable their patients to look critically at the information available about medical tourism providers and to ask critical questions of patients deciding to access care abroad.

Millions of people undergo displacement in the world. Internally displaced people (IDP) are especially vulnerable as they are not protected by special legislation in contrast to other migrants. Research conducted among IDPs must be correspondingly sensitive in dealing with ethical issues that may arise. Muslim IDPs in Puttalam district in the North-Western province of Sri Lanka were initially displaced from Northern Sri Lanka due to the conflict in 1991. In the backdrop of a study exploring the prevalence of common mental disorders among the IDPs, researchers encountered various ethical challenges. These included inter-related issues of autonomy, non-maleficence, beneficence, confidentiality and informed consent, and how these were tailored in a culture-specific way to a population that has increased vulnerability. This paper analyses how these ethical issues were perceived, detected and managed by the researchers, and the role of ethics review committees in mental health research concerning IDPs. The relevance of guidelines and methodologies in the context of an atypical study population and the benefit versus risk potential of research for IDPs are also discussed. The limitations that were encountered while dealing with ethical challenges during the study are discussed. The concept of post-research ethical conduct audit is suggested to be considered as a potential step to minimize the exploitation of vulnerable populations such as IDPs in mental health research.

Background Bioethics and law distinguish between the practices of "physician-assisted death" and "allowing the patient to die." Discussion Advances in biotechnology have allowed medical devices to be used as destination therapy that are designed for the permanent support of cardiac function and/or respiration after irreversible loss of these spontaneous vital functions. For permanent support of cardiac function, single ventricle or biventricular mechanical assist devices and total artificial hearts are implanted in the body. Mechanical ventilators extrinsic to the body are used for permanent support of respiration. Clinical studies have shown that destination therapy with ventricular assist devices improves patient survival compared to medical management, but at the cost of a substantial alteration in end-of-life trajectories. The moral and legal assessment of the appropriateness and permissibility of complying with a patient's request to electively discontinue destination therapy in a life-terminating act in non-futile situations has generated controversy. Some argue that complying with this request is ethically justified because patients have the right to request withdrawal of unwanted treatment and be allowed to die of preexisting disease. Other commentators reject the argument that acceding to an elective request for death by discontinuing destination therapy is 'allowing a patient to die' because of serious flaws in interpreting the intention, causation, and moral responsibility of the ensuing death. Summary Destination therapy with cardiac and/or ventilatory medical devices replaces native physiological functions and successfully treats a preexisting disease. We posit that discontinuing cardiac and/or ventilatory support at the request of a patient or surrogate can be viewed as allowing the patient to die if--and only if--concurrent lethal pathophysiological conditions are present that are unrelated to those functions already supported by medical devices in destination therapy. In all other cases, compliance with a patient's request constitutes physician-assisted death because of the pathophysiology induced by the turning off of these medical devices, as well as the intention, causation, and moral responsibility of the ensuing death. The distinction between allowing the patient to die and physician-assisted death is pivotal to the moral and legal status of elective requests for death by discontinuing destination cardiac and/or ventilatory medical devices in patients who are not imminently dying. This distinction also represents essential information that must be disclosed to patients and surrogates in advance of consent to this type of therapy.

Background Umbilical cord banks are a central component, as umbilical cord tissue providers, in both medical treatment and scientific research with stem cells. But, whereas the creation of umbilical cord banks is seen as successful practice, it is perceived as a risky style of play by others. This article examines and discusses the ethical, medical and legal considerations that arise from the operation of umbilical cord banks in Mexico. Discussion A number of experts have stated that the use of umbilical cord goes beyond the mere utilization of human tissues for the purpose of treatment. This tissue is also used in research studies: genetic studies, studies to evaluate the effectiveness of new antibiotics, studies to identify new proteins, etc. Meanwhile, others claim that the law and other norms for the functioning of cord banks are not consistent and are poorly defined. Some of these critics point out that the confidentiality of donor information is handled differently in different places. The fact that private cord banks offer their services as "biological insurance" in order to obtain informed consent by promising the parents that the tissue that will be stored insures the health of their child in the future raises the issue of whether the consent is freely given or given under coercion. Another consideration that must be made in relation to privately owned cord banks has to do with the ownership of the stored umbilical cord. Summary Conflicts between moral principles and economic interests (non-moral principles) cause dilemmas in the clinical practice of umbilical cord blood storage and use especially in privately owned banks. This article presents a reflection and some of the guidelines that must be followed by umbilical cord banks in order to deal with these conflicts. This reflection is based on the fundamental notions of ethics and public health and seeks to be a contribution towards the improvement of umbilical cord banks' performance.

Background Few comparative studies of clinical ethics consultation practices have been reported. The objective of this study was to explore how American and Japanese experts analyze an Alzheimer's case regarding ethics consultation. Methods We presented the case to physicians and ethicists from the US and Japan (one expert from each field from both countries; total = 4) and obtained their responses through a questionnaire and in-depth interviews. Results Establishing a consensus was a common goal among American and Japanese participants. In attempting to achieve consensus, the most significant similarity between Japanese and American ethics consultants was that they both appeared to adopt an "ethics facilitation" approach. Differences were found in recommendation and assessment between the American and Japanese participants. In selecting a surrogate, the American participants chose to contact the grandson before designating the daughter-in-law as the surrogate decision-maker. Conversely the Japanese experts assumed that the daughter-in-law was the surrogate. Conclusion Our findings suggest that consensus building through an "ethics facilitation" approach may be a commonality to the practice of ethics consultation in the US and Japan, while differences emerged in terms of recommendations, surrogate assessment, and assessing treatments. Further research is needed to appreciate differences not only among different nations including, but not limited to, countries in Europe, Asia and the Americas, but also within each country.