The use of black box algorithms in medicine has raised scholarly concerns due to their opaqueness and lack of trustworthiness. Concerns about potential bias, accountability and responsibility, patient autonomy and compromised trust transpire with black box algorithms. These worries connect epistemic concerns with normative issues. In this paper, we outline that black box algorithms are less problematic for epistemic reasons than many scholars seem to believe. By outlining that more transparency in algorithms is not always necessary, and by explaining that (...) computational processes are indeed methodologically opaque to humans, we argue that the reliability of algorithms provides reasons for trusting the outcomes of medical artificial intelligence. To this end, we explain how computational reliabilism, which does not require transparency and supports the reliability of algorithms, justifies the belief that results of medical AI are to be trusted. We also argue that several ethical concerns remain with black box algorithms, even when the results are trustworthy. Having justified knowledge from reliable indicators is, therefore, necessary but not sufficient for normatively justifying physicians to act. This means that deliberation about the results of reliable algorithms is required to find out what is a desirable action. Thus understood, we argue that such challenges should not dismiss the use of black box algorithms altogether but should inform the way in which these algorithms are designed and implemented. When physicians are trained to acquire the necessary skills and expertise, and collaborate with medical informatics and data scientists, black box algorithms can contribute to improving medical care. (shrink)
Mobile health is rapidly being implemented and changing our ways of doing, understanding and organising healthcare. mHealth includes wearable devices as well as apps that track fitness, offer wellness programmes or provide tools to manage chronic conditions. According to industry and policy makers, these systems offer efficient and cost-effective solutions for disease prevention and self-management. While this development raises many ethically relevant questions, so far mHealth has received only little attention in medical ethics. This paper provides an overview of bioethical (...) issues raised by mHealth and aims to draw scholarly attention to the ethical significance of its promises and challenges. We show that the overly positive promises of mHealth need to be nuanced and their desirability critically assessed. Finally, we offer suggestions to bioethicists to engage with this emerging trend in healthcare to develop mHealth to its best potential in a morally sound way. (shrink)
The authors of the paper ‘Advance euthanasia directives: a controversial case and its ethical implications’ articulate concerns and reasons with regard to the conduct of euthanasia in persons with dementia based on advance directives. While we agree on the conclusion that there needs to be more attention for such directives in the preparation phase, we disagree with the reasons provided by the authors to support their conclusions. We will outline two concerns with their reasoning by drawing on empirical research and (...) by providing reasons that contradict their assumptions about competence of people with dementia and the importance of happiness in reasoning about advance directives of people with dementia. We will draw attention to the important normative questions that have been overstepped in their paper, and we will outline why further research is required. (shrink)
Dementia is highly prevalent and incurable. The participation of dementia patients in clinical research is indispensable if we want to find an effective treatment for dementia. However, one of the primary challenges in dementia research is the patients’ gradual loss of the capacity to consent. Patients with dementia are characterized by the fact that, at an earlier stage of their life, they were able to give their consent to participation in research. Therefore, the phase when patients are still competent to (...) decide offers a valuable opportunity to authorize research, by using an advance research directive. Yet, the use of ARDs as an authorization for research participation remains controversial. In this paper we discuss the role of autonomous decision-making and the protection of incompetent research subjects. We will show why ARDs are a morally defensible basis for the inclusion of this population in biomedical research and that the use of ARDs is compatible with the protection of incompetent research subjects. (shrink)
Healthcare collectives, such as patient organizations, advocacy groups, disability organizations, professional associations, industry advocates, social movements, and health consumer organizations have been increasingly involved in healthcare policymaking. Such collectives are based on the idea that individual interests can be aggregated into collective interests by participation, deliberation, and representation. The topic of collectivity in healthcare, more specifically collective representation, has only rarely been addressed in bioethics. This symposium, entitled: “Collective Representation in Healthcare Policy” of the Journal of Bioethical Inquiry draws attention (...) to this understudied topic from a variety of disciplines, within a variety of socio-cultural contexts. We draw attention to important ethical, cultural, and social questions, and into the practices, justifications for, and implications of collective representation of patients in healthcare policy. (shrink)
Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can (...) meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance. No data are available. (shrink)
Biomedical research funding bodies across Europe and North America increasingly encourage—and, in some cases, require—investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what ‘good’ or ‘successful’ public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for (...) the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public involvement should be undertaken in the first place. We show that presented without this justificatory context, many of the recommendations in the Standards are, at best, fragments that require substantial elaboration by those looking to apply the Standards in their own work and, at worst, subject to potentially harmful misapplication by well-meaning investigators. As funding bodies increasingly push for public involvement in research, the key lesson of our analysis is that future recommendations about how public involvement should be conducted cannot be coherently formulated without a clear sense of the underlying goals and rationales for public involvement. (shrink)
Precision medicine research involving human biological material is becoming an increasingly central component of healthcare, and its potential is quickly growing due to rapid technological progress...
Autonomy of people on the autism-spectrum has only been very rarely conceptually explored. Autism spectrum is commonly considered a hetereogenous disorder, and typically described as a behaviorally-defined neurodevelopmental disorder associated with the presence of social-communication deficits and restricted and repetitive behaviors. Autism research mainly focuses on the behavior of autistic people and ways to teach them skills that are in line with social norms. Interventions such as therapies are being justified with the assumption that autists lack the capacity to be (...) self-reflective and to be “author of their lives”. We question this assumption, as some empirical research shows that autists are aware of their strengths and are critical about social norms, we take this as a starting point to reconsider the beliefs about autistic people’s capacities. As a theoretical framework, we draw on Berlin’s idea of positive and negative liberty as he clearly distinguishes between one’s own developed preferences and the simple absence of interference. By drawing on the concept of positive liberty, we illustrate that a lot of autists are aware of their own needs, and usually do not deny their own needs, values and interests. This makes them less prone than non-autistic people to adapt their preferences to external influences, which might be seen as sticking to an authentic way of living. Our analysis shows that many autists are hindered to be autonomous due to unjustified interference, unreflected assumptions about their self-determination, or by paternalistic actions. These observations contribute to a better understanding when help and interference are justified and a more differentiated understanding of autonomy of autistic people. (shrink)
Children and adults with dementia are vulnerable populations. Both groups are also relatively seldom included in biomedical research. However, including them in clinical trials is necessary, since both groups are in need of scientific innovation and new therapies. Their dependence and limited decision-making capacities increase their vulnerability, necessitating extra precautions when including them in clinical trials. Beside these similarities there are also many differences between the groups. The most obvious one is that children have an entire life ahead of them (...) and will become persons with certain ideals and preferences, while adults with dementia have lived a life in which they have expressed their ideals and preferences. Some of the available research guidelines recognize these differences, setting one list of specific requirements for groups of incapacitated adults and another list for children. Other documents, however, do not differentiate and only set requirements for subjects unable to consent as a single category of subjects. In this article we analyse to what extent the similarities and differences between the two groups are represented in legal documents and ethical guidelines. The article presents an overview and an analysis of the requirements for doing research with children and dementia patients. We conclude with suggestions about how to better incorporate the morally relevant aspects of these two groups in legislation and ethical guidelines. (shrink)
This paper analyses self-declared aims and representation of dementia patient organizations and advocacy groups in relation to two recent upheavals: the critique of social stigmatization and biomedical research focusing on prediction. Based on twenty-six semi-structured interviews conducted in 2016–2017 with members, service recipients, and board representatives of POs in Germany and Israel, a comparative analysis was conducted, based on a grounded theory approach, to detect emerging topics within and across the POs and across national contexts. We identified a heterogeneous landscape, (...) with the only Israeli PO focusing strongly on caretakers, whereas in Germany several POs claim to represent this patient collective. Shared aims of all POs were fighting social stigma, balancing the loss of patients’ individual autonomy, and the well-being of caretakers. By highlighting the emergence of new groups of dementia self-advocacy against the more traditional advocacy by others, this study highlights how advocacy and representation in the context of AD are embedded in the discursive context of stigmatization and revised disease conception. Future developments in early diagnosis and prediction of dementia, with more affected people likely to conduct dementia self-advocacy, might challenge existing representation structures even more. (shrink)
Dementia is highly prevalent and up until now, still incurable. If we may believe the narrative that is currently dominant in dementia research, in the future we will not have to suffer from dementia anymore, as there will be a simple techno-fix solution. It is just a matter of time before we can solve the growing public health problem of dementia. In this paper we take a critical stance towards overly positive narratives of techno-fixes by placing our empirical analysis of (...) dementia research protocols and political statements in a framework of technology assessment. From this perspective, it becomes obvious that a techno-fix is just one of many ways to approach societal problems and more importantly that technologies are way less perfect than they are presented. We will argue that this narrow scope, which focusses on the usual suspects for solving illnesses, reduces dementia to organismic aspects, and may be counterproductive in finding a cure for dementia. We conclude with outlining how the narrow scope can be balanced with other narratives and why we should have a reasonable scepticism towards the usual suspects. (shrink)
In order to discover an effective treatment for dementia it is necessary to include dementia patients in clinical research trials. Dementia patients face an increased risk to lose the capacity to consent to research participation, and research possibilities with incompetent participants are legally strictly limited. One solution is for patients to consent to research through an advance research directive whilst still competent. In order to explore whether such a directive would be useful and valuable in practice we conducted a qualitative (...) study. We explored the opinions and arguments of researchers in the field of dementia, aiming to map the possibilities and constraints of ARDs. It was argued that a positive ARD could be valuable to discuss research participation with proxies, and patients with a negative ARD will be excluded from research trials. However, it is argued that an ARD cannot replace the informed consent procedure, and in practice proxy dissent will overrule written consent. The practical use of these directives is thus limited, as most researchers will not comply with positive directives. (shrink)
BackgroundGene drive technologies promote the rapid spread of a particular genetic element within a population of non-human organisms. Potential applications of GDTs include the control of insect vectors, invasive species and agricultural pests. Whether, and if so, under what conditions, GDTs should be deployed is hotly debated. Although broad stances in this debate have been described, the convictions that inform the moral views of the experts shaping these technologies and related policies have not been examined in depth in the academic (...) literature.MethodsIn this qualitative study, we interviewed GDT experts from different disciplines to identify and better understand their moral views regarding these technologies. The pseudonymized transcripts were analyzed thematically.ResultsThe respondents’ moral views were principally influenced by their attitudes towards the uncertainty related to GDTs; the alternatives to which they should be compared; and the role humans should have in nature. Respondents agreed there is epistemic uncertainty related to GDTs, identified similar knowledge gaps, and stressed the importance of realistic expectations in discussions on GDTs. They disagreed about whether uncertainty provides a rationale to refrain from field trials or to proceed with phased testing to obtain more knowledge given the harms of the status quo. With regards to alternatives to tackle vector-borne diseases, invasive species and agricultural pests, respondents disagreed about which alternatives should be considered feasible and sufficiently explored: conventional strategies or systematic changes to health care, political and agricultural systems. Finally, respondents held different views on nature and whether the use of GDTs is compatible with humans’ role in nature or not.ConclusionsThis interview study helps to disentangle the debate on GDTs by providing a better understanding of the moral views of GDT experts. The obtained insights provide valuable stepping-stones for a constructive debate about underlying value conflicts and call attention to topics that deserve further reflection. Further evaluation of these issues can facilitate the debate on and responsible development of GDTs. (shrink)
We would like to thank the authors of the commentaries for their critical appraisal of our feature article, Who is afraid of black box algorithms?1 Their comments, suggestions and concerns are various, and we are glad that our article contributes to the academic debate about the ethical and epistemic conditions for medical Explanatory AI. We would like to bring to attention a few issues that are common worries across reviewers. Most prominently are the merits of computational reliabilism —in particular, when (...) promoted as an alternative to transparency—and CR as necessary but not sufficient for delivering trust. We finalise our response by addressing concerns about the place and role of artificial intelligence in medical decision-making and the physician’s responsibilities. We understand the concerns and reservations that some of the reviewers express regarding the epistemic merits of CR. We believe that, in part, this is due to a practice too deeply rooted in transparency. But on …. (shrink)
BackgroundOur human societies and certainly also 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: disentangling wicked problems, upstream or midstream ethical analysis, ethics from within, inclusion of empirical research, public participation and 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. (shrink)
Scientific discoveries are often to some degree influenced by luck. Whether luck’s influence is at odds with common-sense intuitions about responsibility, is the central concern of the philosophical debate about moral luck. Do scientists acknowledge that luck plays a role in their work and – if so – do they consider it morally problematic? The present article discusses the results of four focus groups with scientists, who were asked about their views on luck in their fields and its moral implications. (...) The participants underscored circumstantial luck as a key dimension of luck in science. Nevertheless, most participants insisted that there are ways of executing ‘control’ in science: They believe that virtues and skills can increase one’s chances for success. The cultivation of these skills and virtues was considered a reasonable ground for pride. Prizes and rewards were rarely tied to personal desert, but instead to their societal function. (shrink)
Unsere Sicht der Demenz ist von kulturellen Metaphern geprägt. Sie ziehen Analogien zu vertrauten Erfahrungsbereichen und eröffnen so ein Verständnis von einem ansonsten schwer fassbaren und letzten Endes unergründlichen Geschehen. In zeitgenössischen Diskursen über die Demenz spielen insbesondere zwei biographische Metaphern eine maßgebliche Rolle: die der,Rückkehr in die Kindheit‘ und die des,Todes bei lebendigem Leib‘. Der Beitrag unterzieht beide Vorstellungen einer kritischen Reflexion. Er erläutert zunächst die kulturgeschichtliche Herkunft und Bedeutung der Kindheits- und Todesmetapher. Im Anschluss geht er ihren Implikationen (...) für das Verständnis von Demenz und die Einstellungen und Verhaltensweisen gegenüber den Betroffenen nach. Dabei kommt eine Lebensverlaufsperspektive zum Tragen, die die Bedeutung der zeitlichen Erstreckung und Verlaufsstruktur des menschlichen Lebens für die ethische Theoriebildung systematisch zu berücksichtigen sucht. Auf diese Weise lässt sich verdeutlichen, dass beide Metaphern die Altersdemenz letztlich einem anderen Punkt des menschlichen Lebens angleichen und sie damit in je unterschiedlicher Weise als eine Art biographischer Normabweichung auffassen. Die Auseinandersetzung erlaubt Schlussfolgerungen mit Blick auf medizin- und pflegeethische Debatten um Selbstbestimmung, Stellvertreterentscheidungen und Vorausverfügungen im Kontext der Altersdemenz. Auf einer theoretisch-konzeptionellen Ebene verdeutlicht sie darüber hinaus auch die Bedeutung einer biographie- und kultursensiblen Perspektive für die ethische Theoriebildung im Allgemeinen. (shrink)
