Research from behavioural sciences shows that people reach decisions in a much less rational and well-considered way than was often assumed. The doctrine of informed consent, which is an important ethical principle and legal requirement in medical practice, is being challenged by these insights into decision-making and real-world choice behaviour. This article discusses the implications of recent insights of research on decision-making behaviour for the informed consent doctrine. It concludes that there is a significant tension between the often non-rational choice (...) behaviour and the traditional theory of informed consent. Responsible ways of dealing with or solving these problems are considered. To this end, patient decisions aids are discussed as suitable interventions to support autonomous decision-making. However, current PDAs demand certain improvements in order to protect and promote autonomous decision-making. Based on a conception of autonomy, we will argue which type of improvements are needed. (shrink)

:In this article, we consider contexts or domains in which moral bioenhancement interventions possibly or most likely will be implemented. By looking closely at similar or related existing practices and their relevant ethical frameworks, we hope to identify ethical considerations that are relevant for evaluating potential moral bioenhancement interventions. We examine, first, debates on the proper scope of moral education; second, proposals for identifying early risk factors for antisocial behaviour; and third, the difficult balancing of individual freedom and third party (...) concerns in psychiatry. In imagining moral bioenhancement in practice, we observe that unlike other forms of enhancement, moral enhancement fundamentally asks how the interests and preferences of the individual and the interests of others should be weighed. Highly diverse domains such as education, mental health, and the judicial domain might be involved, and moral bioenhancement might challenge existing institutional settings. Given these highly varied contexts and domains, it appears unlikely that there will be a distinct set of practices that will be referred to as “moral bioenhancement.”. (shrink)

To gain insight into the reasons that the public may have for endorsing or eschewing pharmacological moral enhancement for themselves or for others, we used empirical tools to explore public attitudes towards these issues. Participants from the United States were recruited via Amazon’s Mechanical Turk and were randomly assigned to read one of several contrastive vignettes in which a 13-year-old child is described as bullying another student in school and then is offered an empathy-enhancing program. The empathy-enhancing program is described (...) as either involving taking a pill or playing a video game on a daily basis for four weeks. In addition, participants were asked to imagine either their own child bullying another student at school, or their own child being bullied by another student. This resulted in a 2 × 2 between-subjects design. In an escalating series of morally challenging questions, we asked participants to rate their overall support for the program; whether they would support requiring participation; whether they would support requiring participation of children who are at higher risk to become bullies in the future; whether they would support requiring participation of all children or even the entire population; and whether they would be willing to participate in the program themselves. We found that people were significantly more troubled by pharmacological as opposed to non-pharmacological moral enhancement interventions. The results indicate that members of the public for the greater part oppose pharmacological moral bioenhancement, yet are open to non-biomedical means to attain moral enhancement. [248 words]. (shrink)

Many healthy volunteers choose to take part in Alzheimer’s disease prevention studies because they want to know whether they will develop dementia—and what they can do to reduce their risk—and are therefore interested in learning the results of AD biomarker tests. Proponents of AD biomarker disclosure often refer to the personal utility of AD biomarkers, claiming that research participants will be able to use AD biomarker information for personal purposes, such as planning ahead or making important life decisions. In this (...) paper, the claim that AD biomarkers have personal utility for asymptomatic individuals is critically assessed. It demonstrates that in the absence of clinical validity, AD biomarkers cannot have personal utility and do not serve research participants’ autonomy. Over the next few years, many research groups will be confronted with participants’ preferences to learn the results of AD biomarker tests. When researchers choose to make results available upon explicit request, they should ensure adequate information provision and education, notably on the uncertain clinical significance of AD biomarker information. Routine disclosure of AD biomarkers to cognitively unimpaired individuals in research settings cannot be justified with an appeal to the personal utility of AD biomarker information. (shrink)

Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that current (...) practices of information provision are insufficient and that there is a place – and a need – for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. (shrink)

The field of Neuro-Engineering seems to be on the fast track towards accomplishing its ultimate goal of potentially replacing the nervous system in the face of disease. Meanwhile, the patients and professionals involved are continuously dealing with human bodily experience and especially how neuro-engineering devices could become part of a user’s body schema: the domain of ‘embodied phenomenology’. This focus on embodiment, however, is not sufficiently reflected in the current literature on ethical and philosophical issues in neuro-engineering. In this article (...) we will focus on this lacuna by explaining existing data on neuro-engineering user’s experiences by using phenomenological concepts such as transparency and the concepts that may facilitate this: functionality, sensorimotor feedback and affective tolerance. By introducing and applying these concepts to four real life case examples, we will discuss practical implications and guidelines which can contribute to the actual success of incorporation of the device by the patient. First, we will discuss the importance of a ‘Patient Preference Diagnosis’, which can serve as a way to prepare the patient for the existential reorientation involved in the process. In addition, a Patient Transparency Diagnosis during and after such a process is also relevant when wanting to provide the medical field in general with feedback, and the patient in particular with possibilities to fine-tune the device. From these practical guidelines we will conclude that the phenomenological approach can be very valuable when applied to the field of neuro-engineering. (shrink)

Alzheimer’s Disease (AD) provides an excellent case study to investigate emerging conceptions of health, disease, pre-disease, and risk. Two scientific working groups have recently reconceptualized AD and created a new category of asymptomatic biomarker positive persons, who are either said to have preclinical AD, or to be at risk for AD. This article examines how prominent theories of health and disease would classify this condition: healthy or diseased? Next, the notion of being “at risk”—a state somewhere in-between health and disease—is (...) considered from various angles. It is concluded that medical-scientific developments urge us to let go of dichotomous ways of understanding disease, that the notion of “risk,” conceptualized as an increased chance of getting a symptomatic disease, might be a useful addition to our conceptual framework, and that we should pay more attention to the practical usefulness and implications of the ways in which we draw lines and define concepts. (shrink)

The field of Neuro-Engineering seems to be on the fast track towards accomplishing its ultimate goal of potentially replacing the nervous system in the face of disease. Meanwhile, the patients and professionals involved are continuously dealing with human bodily experience and especially how neuro-engineering devices could become part of a user’s body schema: the domain of ‘embodied phenomenology’. This focus on embodiment, however, is not sufficiently reflected in the current literature on ethical and philosophical issues in neuro-engineering. In this article (...) we will focus on this lacuna by explaining existing data on neuro-engineering user’s experiences by using phenomenological concepts such as transparency and the concepts that may facilitate this: functionality, sensorimotor feedback and affective tolerance. By introducing and applying these concepts to four real life case examples, we will discuss practical implications and guidelines which can contribute to the actual success of incorporation of the device by the patient. First, we will discuss the importance of a ‘Patient Preference Diagnosis’, which can serve as a way to prepare the patient for the existential reorientation involved in the process. In addition, a Patient Transparency Diagnosis during and after such a process is also relevant when wanting to provide the medical field in general with feedback, and the patient in particular with possibilities to fine-tune the device. From these practical guidelines we will conclude that the phenomenological approach can be very valuable when applied to the field of neuro-engineering. (shrink)

Health checks identify disease in individuals without a medical indication. More and more checks are offered by more providers on more risk factors and diseases, so we may speak of an omnipresence of health checks. Current ethical evaluation of health checks considers checks on an individual basis only. However, omnipresent checks have effects over and above the effects of individual health checks. They might give the impression that health is entirely manageable by individual actions and strengthen the norm of individual (...) responsibility for health to the point where people hold themselves and others responsible for health outcomes they cannot reasonably be held accountable for. This process of so-called ‘over-responsibilization’ may result in increased feelings of guilt over health, decreased health solidarity and unfairly distributed health outcomes. Moreover, effects on privacy and peace of mind may be observed. Taking into account all possible harms and benefits of health checks in their ethical evaluation requires evaluation of health checks on an individual basis as well as on the level of all checks. Therefore, we urge the amendment of existing ethical evaluation to include the effects of an omnipresence of health checks. We make a first attempt at the formulation of amended criteria. (shrink)

Health checks identify disease in people without symptoms. They may be offered by the government through population screenings and by other providers to individual users as ‘personal health checks’. Health check providers’ perspective of ‘good’ health checks may further the debate on the ethical evaluation and possible regulation of these personal health checks. In 2015, we interviewed twenty Dutch health check providers on criteria for ‘good’ health checks, and the role these criteria play in their practices. Providers unanimously formulate a (...) number of minimal criteria: Checks must focus on treatable/preventable disease; Tests must be reliable and clinically valid; Participation must be informed and voluntary; Checks should provide more benefits than harms; Governmental screenings should be cost-effective. Aspirational criteria mentioned were: Follow-up care should be provided; Providers should be skilled and experienced professionals that put the benefit of users first; Providers should take time and attention. Some criteria were contested: People should be free to test on any disease; Health checks should only be performed in people at high risk for disease that are likely to implement health advice; Follow up care of privately funded tests should not drain on collective resources. Providers do not always fulfil their own criteria. Their reasons reveal conflicts between criteria, conflicts between criteria and other ethical values, and point to components in the organisation of health care that hinder an ethical provision of health checks. Moreover, providers consider informed consent a criterion that is hard to establish in practice. According to providers, personal health checks should meet the same criteria as population screenings, with the exception of cost-effectiveness. Providers do not always fulfil their own criteria. Results indicate that in thinking about the ethics of health checks potential conflicts between criteria and underlying values should be explicated, guidance in weighing of criteria should be provided and the larger context should be taken into account: other actors than providers need to take up responsibility, and ideally benefits and harms of health checks should be weighed against other measures targeting disease. (shrink)

Broad genome‐wide testing is increasingly finding its way to the public through the online direct‐to‐consumer marketing of so‐called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision‐making with regard to the testing offer, we argue that current (...) practices of information provision are insufficient and that there is a place – and a need – for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. (shrink)

An increasing number of people seek medical attention for mild cognitive symptoms at older age, worried that they might develop Alzheimer’s disease. Some clinical practice guidelines suggest offering biomarker testing in such cases, using a brain scan or a lumbar puncture, to improve diagnostic certainty about Alzheimer’s disease and enable an earlier diagnosis. Critics, on the other hand, point out that there is no effective Alzheimer treatment available and argue that biomarker tests lack clinical validity. The debate on the ethical (...) desirability of biomarker testing is currently polarized; advocates and opponents tend to focus on their own line of arguments. In this paper, we show how the method of reflective equilibrium can be used to systematically weigh the relevant arguments on both sides of the debate to decide whether to offer Alzheimer biomarker testing. In the tradition of RE, we reflect upon these arguments in light of their coherence with other argumentative elements, including relevant facts, ethical principles, and theories on societal ideals or relevant concepts, such as autonomy. Our stance in the debate therefore rests upon previously set out in-depth arguments and reflects a wide societal perspective. (shrink)

This study investigates what professional caregivers working in nursing homes consider to be a good life for residents suffering from dementia. Ten caregivers were interviewed; special attention was paid to the way in which they deal with conflicting values. Transcripts of the interviews were analysed qualitatively according to the method of grounded theory. The results were compared with those from a similar, earlier study on ideals found in mission statements of nursing homes. The concepts that were mentioned by most interviewed (...) participants as important for a good life were ‘peace and quiet’, ‘going along with subjective experience’ and ‘no enforcement: the way the resident wants it’. A considerable overlap was found between the interviews and the mission statements; however, when compared with the mission statements, the interviews put less emphasis on individuality and on giving meaning, and more on offering residents pleasant activities. When faced with conflicting values, caregivers tend to make pragmatic and more or less intuitive decisions. Although this has its merits, it may be desirable to stimulate conscious reflection regarding conflict between different values. (shrink)

In the context of debates on psychiatry issues pertaining to moral dimensions of psychiatric health care are frequently discussed. These debates invite reflection on the question whether forensic practitioners have a role in stimulating patients’ moral development and moral growth in the context of forensic psychiatric and psychological treatment and care. We conducted a qualitative study to examine to what extent forensic practitioners consider moral development and moral growth to be a part of their current professional practices and to what (...) extent they think that stimulating moral development is a legitimate objective in the context of forensic psychiatric treatment. In addition, we asked how forensic practitioners balance pubic safety and risk management concerns with the interests and wellbeing of the individual patient. We conclude that: elements of moral development and moral growth in forensic psychiatric care practices are to a certain extent inevitable and not necessarily questionable or undesirable; yet, as in similar debates these elements need to be made explicit in order to discuss the accompanying ethical challenges and boundaries. An open academic, professional and public debate on aspects of stimulating moral betterment within current practices is therefore desirable. (shrink)

Health checks or health screenings identify disease in people without a specific medical indication. So far, the perspective of health check users has remained underexposed in discussions about the ethics and regulation of health checks. In 2017, we conducted a qualitative study with lay people from the Netherlands. We asked what participants consider characteristics of good and bad health checks, and whether they saw a role for the Dutch government. Participants consider a good predictive value the most important characteristic of (...) a good health check. Information before, during and after the test, knowledgeable and reliable providers, tests for treatable disease, respect for privacy, no unnecessary health risks and accessibility are also mentioned as criteria for good health checks. Participants make many assumptions about health check offers. They assume health checks provide certainty about the presence or absence of disease, that health checks offer opportunities for health benefits and that the privacy of health check data is guaranteed. In their choice for provider and test they tend to rely more on heuristics than information. Participants trust physicians to put the interest of potential health check users first and expect the Dutch government to intervene if providers other than physicians failed to do so by offering tests with a low predictive value, or tests that may harm people, or by infringing the privacy of users. Assumptions of participants are not always justified, but they may influence the choice to participate. This is problematic because choices for checks with a low predictive value that do not provide health benefits may create uncertainty and may cause harm to health; an outcome diametrically opposite to the one intended. Also, this may impair the relationship of trust with physicians and the Dutch government. To further and protect autonomous choice and to maintain trust, we recommend the following measures to timely adjust false expectations: advertisements that give an accurate impression of health check offers, and the installation of a quality mark. (shrink)

Background: As genetics technology proceeds, practices of genetic testing have become more heterogeneous: many different types of tests are finding their way to the public in different settings and for a variety of purposes. This diversification is relevant to the discourse on ethical, legal and societal issues (ELSI) surrounding genetic testing, which must evolve to encompass these differences. One important development is the rise of personal genome testing on the basis of genetic profiling: the testing of multiple genetic variants simultaneously (...) for the prediction of common multifactorial diseases. Currently, an increasing number of companies are offering personal genome tests directly to consumers and are spurring ELSI-discussions, which stand in need of clarification. This paper presents a systematic approach to the ELSI-evaluation of personal genome testing for multifactorial diseases along the lines of its test characteristics.DiscussionThis paper addresses four test characteristics of personal genome testing: its being a non-targeted type of testing, its high analytical validity, low clinical validity and problematic clinical utility. These characteristics raise their own specific ELSI, for example: non-targeted genetic profiling poses serious problems for information provision and informed consent. Questions about the quantity and quality of the necessary information, as well as about moral responsibilities with regard to the provision of information are therefore becoming central themes within ELSI-discussions of personal genome testing. Further, the current low level of clinical validity of genetic profiles raises questions concerning societal risks and regulatory requirements, whereas simultaneously it causes traditional ELSI-issues of clinical genetics, such as psychological and health risks, discrimination, and stigmatization, to lose part of their relevance. Also, classic notions of clinical utility are challenged by the newer notion of 'personal utility.'SummaryConsideration of test characteristics is essential to any valuable discourse on the ELSI of personal genome testing for multifactorial diseases. Four key characteristics of the test - targeted/non-targeted testing, analytical validity, clinical validity and clinical utility - together determine the applicability and the relevance of ELSI to specific tests. The paper identifies and discusses four areas of interest for the ELSI-debate on personal genome testing: informational problems, risks, regulatory issues, and the notion of personal utility. (shrink)

Informed decision-making (IDM) is considered an important ethical and legal requirement for population-based screening. Governments offering such screening have a duty to enable invitees to make informed decisions regarding participation. Various views exist on how to define and measure IDM in different screening programmes. In this paper we first address the question which components should be part of IDM in the context of cancer screening. Departing from two diverging interpretations of the value of autonomy—as a right and as an ideal—we (...) describe how this value is operationalized in the practice of informed consent in medicine and translate this to IDM in population-based cancer screening. Next, we specify components of IDM, which is voluntariness and the requirements of disclosure and understanding. We argue that whereas disclosure should contain all information considered relevant in order to enable authentic IDM, understanding of basic information is sufficient for a valid IDM. In the second part of the paper we apply the capability approach in order to argue for the responsibility of the government to warrant equal and real opportunities for invitees for IDM. We argue that additional conditions beyond mere provision of information are needed in order to do so. (shrink)

Cardiovascular health checks test risk factors for cardiovascular disease. They are offered to improve health: in case of an increased risk, participants receive lifestyle advice and medication. With this review, we investigate what is known about the reasons why people do or do not test for CVD risk factors. To what extent do these reasons relate to health monitoring and/or improvement? And do reasons differ in different contexts in which health checks are offered? We conducted a literature search and included (...) 22 papers in which we identified a broad range of motives. We conclude that people have reasons to test related to health improvement and reasons other than health improvement, practical reasons related to the way health checks are offered play an important role and motives should be understood in the context of the situation in which health checks are offered. Our results are relevant for public health officials and providers of health checks: first, if people undergo testing for reasons unrelated to health, this could explain why participation in health checks does not necessarily lead to health improvement. Second, efforts to improve uptake not necessarily serve justice and may hamper informed consent. (shrink)