Background Since the enactment of the euthanasia law in the Netherlands, there has been a lively public debate on assisted dying that may influence the way patients talk about euthanasia and physician-assisted suicide with their physicians and the way physicians experience the practice of EAS. Aim To show what developments physicians see in practice and how they perceive the influence of the public debate on the practice of EAS. Methods We conducted a secondary analysis of in-depth interviews with 28 Dutch (...) physicians who had experience with a complex case of EAS. Respondents were recruited both by the network of physicians working for SCEN as well as via a national questionnaire, wherein participating physicians could indicate their willingness to be interviewed. Results Three themes came up in analysing the interviews. First, the interviewed physicians experienced a change in what patients would expect from them: from a role as an involved caregiver to being the mere performer of EAS. Second, interviewees said that requests for EAS based on non-medical reasons came up more frequently and wondered if EAS was the right solution for these requests. Last, respondents had the impression that the standards of EAS are shifting and that the boundaries of the EAS regulation were stretched. Conclusions The perceived developments could make physicians less willing to consider a request for EAS. Our results also raise questions about the role of physicians and of EAS in society. (shrink)

Background In the ethical and clinical literature, cases of parents who want treatment for their child to be withdrawn against the views of the medical team have not received much attention. Yet resolution of such conflicts demands much effort of both the medical team and parents. Objective To discuss who can best protect a child9s interests, which often becomes a central issue, putting considerable pressure on mutual trust and partnership. Methods We describe the case of a 3-year-old boy with acquired (...) brain damage due to autoimmune-mediated encephalitis whose parents wanted to stop treatment. By comparing this case with relevant literature, we systematically explored the pros and cons of sharing end-of-life decisions with parents in cases where treatment is considered futile by parents and not (yet) by physicians. Conclusions Sharing end-of-life decisions with parents is a more important duty for physicians than protecting parents from guilt or doubt. Moreover, a request from parents on behalf of their child to discontinue treatment is, and should be, hard to over-rule in cases with significant prognostic uncertainty and/or in cases with divergent opinions within the medical team. (shrink)

BackgroundConsent for data research in acute and critical care is complex as patients become at least temporarily incapacitated or die. Existing guidelines and regulations in the European Union are of limited help and there is a lack of literature about the use of data from this vulnerable group. To aid the creation of a patient-centred framework for responsible data research in the acute setting, we explored views of patients and next-of-kin about the collection, storage, sharing and use of genetic and (...) health-related data for observational research.MethodsWe conducted qualitative interviews (n = 19) with Dutch sudden cardiac arrest survivors who donated clinical and socio-economic data and genetic samples to research. We also interviewed their next-of-kin. Topics were informed by ethics literature and we used scenario-sketches to aid discussion of complex issues.ResultsSudden cardiac arrest survivors displayed limited awareness of their involvement in health data research and of the content of their given consent. We found that preferences regarding disclosure of clinically actionable genetic findings could change over time. When data collection and use were limited to the medical realm, patients trusted researchers to handle data responsibly without concern for privacy or other risks. There was no consensus as to whether deferred consent should be explicitly asked from survivors. If consent is asked, this would ideally be done a few months after the event when cognitive capacities have been regained. Views were divided about the need to obtain proxy consent for research with deceased patients’ data. However, there was general support for the disclosure of potentially relevant post-mortem genetic findings to relatives.ConclusionsSudden cardiac arrest patients’ donation of data for research was grounded in trust in medicine overall, blurring the boundary between research and care. Our findings also highlight questions about the acceptability of a one-time consent and about responsibilities of patients, researchers and ethics committees. Finally, further normative investigation is needed regarding the (continued) use of participants’ data after death, which is of particular importance in this setting. Our findings are thought to be of relevance for other acute and life-threatening illnesses as well. (shrink)

In reference to the different approaches in philosophy(of medicine) of the nature of (medical) technology,this article introduces the topic of this specialissue of Theoretical Medicine and Bioethics, that is,the way the different forms of medical technologyfunction in everyday medical practice. The authorselaborate on the active role technology plays inshaping our views on disease, illness, and the body,whence in shaping our world.

Persons with profound intellectual and multiple disabilities cannot speak about their Quality of Life, which makes it necessary to involve others. In current approaches, these ‘others’ are seen as assessors trying to describe QoL as objectively as possible, which involves a reduction of their experiences, through which they develop knowledge on the QoL of the person with PIMD. The objective of this paper is to give caregivers’ knowledge on the QoL of a person with PIMD a theoretical basis that values (...) these experiences. We will argue that caregivers should be seen as witnesses, not assessors, and their statements on QoL as testimonies, not assessments. Audiences judge the trustworthiness of these witnesses intersubjectively, which implies a relationship characterized by trust and suspicion. Trust supports the witness to tell in her own words about the QoL of the person with PIMD; it demands receptivity, indicating that both the witness and the audience are willing to reconsider their perspective on QoL. Suspicion is necessary too, which helps the witness to critically approach her own interpretations and supports her to create more trustworthy testimonies. We conclude that the concept of witnessing helps to acknowledge caregivers’ experiential knowledge of QoL of a person with PIMD, which may also apply to other persons who cannot speak about their own QoL. We hope that our study will empower caregivers to give testimonies on QoL of a person with PIMD, which is crucial when complex decisions about the life of this person have to be made. (shrink)

BackgroundThe emergence of artificial intelligence (AI) in medicine has prompted the development of numerous ethical guidelines, while the involvement of patients in the creation of these documents lags behind. As part of the European PROFID project we explore patient perspectives on the ethical implications of AI in care for patients at increased risk of sudden cardiac death (SCD).AimExplore perspectives of patients on the ethical use of AI, particularly in clinical decision-making regarding the implantation of an implantable cardioverter-defibrillator (ICD).MethodsSemi-structured, future scenario-based (...) interviews were conducted among patients who had either an ICD and/or a heart condition with increased risk of SCD in Germany (n = 9) and the Netherlands (n = 15). We used the principles of the European Commission’s Ethics Guidelines for Trustworthy AI to structure the interviews.ResultsSix themes arose from the interviews: the ability of AI to rectify human doctors’ limitations; the objectivity of data; whether AI can serve as second opinion; AI explainability and patient trust; the importance of the ‘human touch’; and the personalization of care. Overall, our results reveal a strong desire among patients for more personalized and patient-centered care in the context of ICD implantation. Participants in our study express significant concerns about the further loss of the ‘human touch’ in healthcare when AI is introduced in clinical settings. They believe that this aspect of care is currently inadequately recognized in clinical practice. Participants attribute to doctors the responsibility of evaluating AI recommendations for clinical relevance and aligning them with patients’ individual contexts and values, in consultation with the patient.ConclusionThe ‘human touch’ patients exclusively ascribe to human medical practitioners extends beyond sympathy and kindness, and has clinical relevance in medical decision-making. Because this cannot be replaced by AI, we suggest that normative research into the ‘right to a human doctor’ is needed. Furthermore, policies on patient-centered AI integration in clinical practice should encompass the ethics of everyday practice rather than only principle-based ethics. We suggest that an empirical ethics approach grounded in ethnographic research is exceptionally well-suited to pave the way forward. (shrink)

Most models of patient-physician communication take decision-making as a central concept. However, we found that often the treatment course of metastatic cancer patients is not easy to describe in straightforward terms used in decision-making models but is instead frequently more erratic. Our aim was to analyse these processes as trajectories. We used a longitudinal case study of 13 patients with metastatic colorectal and pancreatic cancer for whom palliative chemotherapy was a treatment option, and analysed 65 semi-structured interviews. We analysed three (...) characteristics of the treatment course that contributed to the ‘erraticness’ of the course: (1) The treatment (with or without chemotherapy) contained many options; (2) these options were not stable entities to be decided upon, but changed identity over the course of treatment, and (3) contrary to the closure (option X means no option Y, Z, etc.) a decision implies, the treatment course was a continuous process in which options instead remained open. When the treatment course is characterised by these many and changeable options that do not result in closure, the shared decision-making model should take these into account. More attention needs to be paid to the erratic character of the process in which the doctor has to provide continuous information that is related to the changing situation of the patient; also, flexibility in dealing with protocols is warranted, as is vigilance about the overall direction of the process. (shrink)

In recent years, to protect the rights and welfare of human subjects, institutions in the USA have begun to set up programmes to monitor ongoing medical research. These programmes provide routine, onsite oversight, and thus go beyond existing oversight such as investigating suspected misconduct or reviewing paperwork provided by investigators. However, because of a lack of guidelines and evidence, institutions have had little guidance in setting up their programmes. To help institutions make the right choices, we used interviews and document (...) analysis to study how and why 11 US institutions have set up their monitoring programmes. Although these programmes varied considerably, we were able to distinguish two general types. ‘Compliance’ programmes on the one hand were part of the institutional review board office and set up to ensure compliance with regulations. Investigators’ participation was mandatory. Monitors focused on documentation. Investigators could be disciplined, and could be obliged to take corrective actions. ‘Quality-improvement’ programmes on the other hand were part of a separate office. Investigators requested to be monitored. Monitors focused more on actual research conduct. Investigators and other parties received feedback on how to improve the research process. Although both types of programmes have their drawbacks and advantages, we argue that if institutions want to set up monitoring programmes, quality improvement is the better choice: it can help foster an atmosphere of trust between investigators and the institutional review board, and can help raise the standards for the protection of human subjects. (shrink)

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

In this article, we use the theory of Information Ethics to argue that deceased people have a prima facie moral right to privacy in the context of health data research, and that this should be reflected in regulation and guidelines. After death, people are no longer biological subjects but continue to exist as informational entities which can still be harmed/damaged. We find that while the instrumental value of recognising post-mortem privacy lies in the preservation of the social contract for health (...) research, its intrinsic value is grounded in respect for the dignity of the post-mortem informational entity. However, existing guidance on post-mortem data protection is available only in the context of genetic studies. In comparing the characteristics of genetic data and other health-related data, we identify two features of DNA often given as arguments for this genetic exceptionalism: relationality and embodiment. We use these concepts to show that at the appropriate Level of Abstraction, there is no morally relevant distinction between posthumous genetic and other health data. Thus, genetic data should not automatically receive special moral status after death. Instead we make a plea for ‘contextual exceptionalism’. Our analysis concludes by reflecting on a real-world case and providing suggestions for contextual factors that researchers and oversight bodies should take into account when designing and evaluating research projects with health data from deceased subjects. (shrink)

Patient-reported outcomes are frequently used for medical decision making, at the levels of both individual patient care and healthcare policy. Evidence increasingly shows that PROs may be influenced by patients’ response shifts and dispositions. We identify how response shifts and dispositions may influence medical decisions on both the levels of individual patient care and health policy. We provide examples of these influences and analyse the consequences from the perspectives of ethical principles and theories of just distribution. If influences of response (...) shift and disposition on PROs and consequently medical decision making are not considered, patients may not receive optimal treatment and health insurance packages may include treatments that are not the most effective or cost-effective. We call on healthcare practitioners, researchers, policy makers, health insurers, and other stakeholders to critically reflect on why and how such patient reports are used. (shrink)