The clinical introduction of medical devices often occurs with relatively little oversight, regulation and (long-term) follow-up. Some recent controversies underscore the weaknesses of the current regime, such as the complications surrounding the metal-on-metal hip implants and the scandal surrounding the global breast implant scare of silicone implants made by France's Poly Implant Prothese (PIP) Company. The absence of national registries hampered the collection of reliable information on the risks and harms of the PIP breast implants. To warrant long-term safety, a (...) case can be made for mandatory post-marketing surveillance by means of the establishment of compulsory registries. In this edition of Public Health Ethics, Schofield calls for debate on how such a registry system should be initiated and maintained and how it would relate to the ethical requirement of consent. Here we use breast implant registries as a case to discuss whether and when a so-called ‘thick opt-out’ would be an appropriate method to include people in medical device registries. We conclude that a thick opt-out procedure for medical device registries is only justifiable in cases where inclusion does not involve burdens (or very low), when it does not involve a sensitive subject and when the data are stored anonymously (or at least not directly linked to the medical record). Otherwise, inclusion should be sought by means of an opt-in. (shrink)

The introduction of chatGPT illustrates the rapid developments within Conversational Artificial Intelligence (CAI) technologies (Gordijn and Have 2023). Ethical reflection and analysis of CAI are c...

United Nations (UN) leaders suggest that the world is not on track to meet the Sustainable Development Goals (SDGs) by 2030. The purpose of this paper is to explore whether the SDGs provide a valuable platform to call for a basic income (BI) globally. Adopting a critical historical studies approach, the article traces the evolution of ‘development’, including the UN decades of development, the Millennium Development Goals, and the SDGs. It subsequently describes the structural adjustment and poverty reduction efforts by (...) the World Bank and International Monetary Fund, and then outlines why the SDG framework may be helpful in advancing a BI. We argue that as climate-related disasters increase, a BI will be vital in providing a modicum of security in an increasingly unstable world. Calls for BI must be anchored to a broader change agenda that recognizes the causes of poverty and income inequality, and seeks their dismantling and redress. (shrink)

BackgroundAs moral case deliberations (MCDs) have increasingly been implemented in health care institutions as a form of ethics support, it is relevant to know whether and how MCDs actually contribute to positive changes in care. Insight is needed on what actually happens in daily care practice following MCD sessions. This study aimed at investigating the impact of MCD and exploring how ‘impact of MCD’ should be conceptualized for future research.MethodsA multiple-case study was conducted in a care organization for people with (...) intellectual disabilities and/or acquired brain injury, by observing MCD sessions as ‘cases’, followed by interviews with health care professionals concerning the follow-up to these cases, and a focus group with involved MCD facilitators. A conceptual scheme concerning the possible impact formed the basis for analysis: (1) individual moral awareness; (2) the actions of health care professionals; (3) collaboration among health care professionals; (4) the concrete situation of the client; (5) the client’s quality of care and life; (6) the organizational and policy level.ResultsAccording to interviewees, their moral awareness and their collaboration, both among colleagues and with clients’ relatives, improved after MCD. Perceived impact on client situation, quality of care/life and the organizational level varied among interviewees or was difficult to define or link to MCD. Three aspects were added to the conceptual scheme concerning the impact of MCD: (a) preparations and expectations prior to the MCD session; (b) a translational step between the conclusions of the MCD session and practical events in the following period, and (c) collaboration with clients’ relatives. A negative impact of MCD was also found on misunderstandings among participants and disappointment about lack of follow-up.ConclusionsConcretizing and conceptualizing the ‘impact’ of MCD is complicated as many factors play a role either before or during the transition from MCD to practice. It is important to consider ‘impact’ in a broad sense and to relate it to the goals and context of the MCD in question. Future studies in this field should pay additional attention to the preparations, content and process involved in ethics support, including clients’ and relatives’ experiences. (shrink)

Background Notwithstanding the need to produce evidence-based knowledge on medications for pregnant women, they remain underrepresented in clinical research. Sometimes they are excluded because of their supposed vulnerability, but there are no universally accepted criteria for considering pregnant women as vulnerable. Our aim was to explore whether and if so to what extent pregnant women are vulnerable as research subjects. Method We performed a conceptual and empirical analysis of vulnerability applied to pregnant women. Analysis A conceptual analysis supports Hurst's definition (...) of vulnerability. Consequently, we argue that pregnant women are vulnerable if they encounter an identifiably increased likelihood of incurring additional or greater wrong. According to the literature, this increased likelihood could exist of four alleged features for pregnant women's vulnerability: informed consent, susceptibility to coercion, higher exposure to risk due to lack of knowledge, vulnerability of the fetus. Discussion Testing the features against Hurst's definition demonstrates that they all concern the same issue: pregnant women are only vulnerable because a higher exposure to risk due to lack of scientific knowledge comprises an increased wrong. Research Ethics Committees have a responsibility to protect the vulnerable, but a higher exposure to risk due to lack of scientific knowledge is a much broader issue and also needs to be addressed by other stakeholders. Conclusions The only reason why pregnant women are potentially vulnerable is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge. Accordingly, the discussion can advance to the development of practical strategies to promote fair inclusion of pregnant women in clinical research. (shrink)

There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as (...) a case-study. We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands. Three themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment. Healthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women. (shrink)

Patient competence, defined as the ability to reason, appreciate, understand, and express a choice is rarely discussed in patients with obsessive compulsive disorder, and coercive measures are seldom used. Nevertheless, a psychiatrist of psychologist may doubt whether OCD patients who refuse treatment understand their disease and the consequences of not being treated, which could result in tension between respecting the patient’s autonomy and beneficence. The purpose of this article is to develop a notion of competence that is grounded in clinical (...) practice and corresponds with the experiences of patients with obsessions and/or compulsions. We present a naturalistic case study giving both the patient’s and the therapist’s perspective based on in-depth interviews and a narrative analysis. The case study shows that competence is not merely an assessment by a therapist, but also a co-constructed reality shaped by the experiences and stories of patient and therapist. The patient, a medical student, initially told her story in a restitution narrative, focusing on cognitive rationality. Reconstructing the history of her disease, her story changed into a quest narrative where there was room for emotions, values and moral learning. This fitted well with the therapist’s approach, who used motivational interventions with a view to appealing to the patient’s responsibility to deal with her condition. We conclude that in practice both the patient and therapist used a quest narrative, approaching competence as the potential for practical reasoning to incorporate values and emotions. (shrink)

Legal and moral reasoning share much methodology, and they address similar problems. This volume charts two shared problems: the relation between theory, principles and particular judgments; and the role of facts and factual assertions in normative settings. The relation between 'theory' and 'practice' and between 'principle' and 'particular judgment' has become the subject of much debate in moral philosophy. In the ongoing debate, some moral philosophers refer to legal philosophy for a support of their views on the primacy of 'practice' (...) over 'theory'. According to them, legal philosophy should have a more balanced view in that relation. In the contributions to Part One this claim is critically analysed. The role of the facts is underestimated in discussions on legal reasoning and legal theory, as well as moral reasoning and ethical theory. Factual statements enter into moral and legal discussions not only because they link the conclusion with a rule. They also play a role as background assumptions in supporting a theory. Its focus on the role of facts in normative reasoning makes this book of special interest to scholars of legal and moral argumentation. (shrink)

The present volume is intended as an all-round introduction to constructivism. Here constructivism is to be understood in the wide sense, and covers in particular Brouwer's intuitionism, Bishop's constructivism and A.A. Markov's constructive recursive mathematics. The ending "-ism" has ideological overtones: "constructive mathematics is the (only) right mathematics"; we hasten, however, to declare that we do not subscribe to this ideology, and that we do not intend to present our material on such a basis.

BackgroundThe COVID-19 pandemic has created ethical challenges for intensive care unit (ICU) professionals, potentially causing moral distress. This study explored the levels and causes of moral distress and the ethical climate in Dutch ICUs during COVID-19.MethodsAn extended version of the Measurement of Moral Distress for Healthcare Professionals (MMD-HP) and Ethical Decision Making Climate Questionnaire (EDMCQ) were online distributed among all 84 ICUs. Moral distress scores in nurses and intensivists were compared with the historical control group one year before COVID-19. ResultsThree (...) hundred forty-five nurses (70.7%), 40 intensivists (8.2%), and 103 supporting staff (21.1%) completed the survey. Moral distress levels were higher for nurses than supporting staff. Moral distress levels in intensivists did not differ significantly from those of nurses and supporting staff. “Inadequate emotional support for patients and their families” was the highest-ranked cause of moral distress for all groups of professionals. Of all factors, all professions rated the ethical climate most positively regarding the culture of mutual respect, ethical awareness and support. “Culture of not avoiding end-of-life-decisions” and “Self-reflective and empowering leadership” received the lowest mean scores. Moral distress scores during COVID-19 were significantly lower for ICU nurses (p < 0.001) and intensivists (p < 0.05) compared to one year prior.ConclusionLevels and causes of moral distress vary between ICU professionals and differ from the historical control group. Targeted interventions that address moral distress during a crisis are desirable to improve the mental health and retention of ICU professionals and the quality of patient care. (shrink)

Sections R1 to R3 attempt to take the sting out of hostile commentaries. Sections R4 to R5 engage Berlin and Kay and the World Color Survey to correct the record. Section R6 begins the formulation of a new theory of colour as an engineering project with a technological developmental trajectory. It is recommended that the colour space be abandoned.

In this target article the following hypotheses are discussed: (1) Colour is autonomous: a perceptuolinguistic and behavioural universal. (2) It is completely described by three independent attributes: hue, brightness, and saturation: (3) Phenomenologically and psychophysically there are four unique hues: red, green, blue, and yellow; (4) The unique hues are underpinned by two opponent psychophysical and/or neuronal channels: red/green, blue/yellow. The relevant literature is reviewed. We conclude: (i) Psychophysics and neurophysiology fail to set nontrivial constraints on colour categorization. (ii) Linguistic (...) evidence provides no grounds for the universality of basic colour categories. (iii) Neither the opponent hues red/green, blue/yellow nor hue, brightness, and saturation are intrinsic to a universal concept of colour. (iv) Colour is not autonomous. (shrink)

A hippocampal patient is described who shows preserved item recognition and simple recognition-based recollection but impaired recall and associative recognition. These data and other evidence suggest that contrary to Aggleton & Brown's target article, Papez circuit damage impairs only complex item-item-context recollection. A patient with perirhinal cortex damage and a delayed global memory deficit, apparently inconsistent with A&B's framework, is also described.

This book concentrates on argumentation as it emerges in ordinary discourse, whether the discourse is institutionalized or strictly informal. Crucial concepts from the theory of argumentation are systematically discussed and explained with the help of examples from real-life discourse and texts. The basic principles are explained that are instrumental in the analysis and evaluation of argumentative discourse. Methodical instruments are offered for identifying differences of opinion, analyzing and evaluating argumentation and presenting arguments in oral and written discourse. In addition, the (...) book provides a great variety of exercises and assignments to improve the students' skill in presenting argumentation. The authors begin their treatment of argumentation theory at the same juncture where argumentation also starts in practice: The difference of opinion that occasions the evolvement of the argumentation. Each chapter begins with a short summary of the essentials and ends with a number of exercises that students can use to master the material. _Argumentation_ is the first introductory textbook of this kind. It is intended as a general introduction for students who are interested in a proper conduct of argumentative discourse. Suggestions for further reading are made for each topic and several extra assignments are added to the exercises. Special features: * A concise and complete treatment of both the theoretical backgrounds and the practice of argumentation analysis and evaluation. * Crucial concepts from pragmatics presented in a non-technical way; introducing the theory of verbal communication. * Unique coverage of both oral and written presentation of arguments. * Exercises and assignments based on real-life texts from a variety of contexts. (shrink)

As humans, we frequently engage in mental time travel, reliving past experiences and imagining possible future events. This study examined whether similar factors affect the subjective experience associated with remembering the past and imagining the future. Participants mentally “re-experienced” or “pre-experienced” positive and negative events that differed in their temporal distance from the present , and then rated the phenomenal characteristics associated with their representations. For both past and future, representations of positive events were associated with a greater feeling of (...) re-experiencing than representations of negative events. In addition, representations of temporally close events contained more sensorial and contextual details, and generated a stronger feeling of re-experiencing than representations of temporally distant events. It is suggested that the way we both remember our past and imagine our future is constrained by our current goals. (shrink)

Surprisingly little has been written about hedged assertion. Linguists often focus on semantic or syntactic theorizing about, for example, grammatical evidentials or epistemic modals, but pay far less attention to what hedging does at the level of action. By contrast, philosophers have focused extensively on normative issues regarding what epistemic position is required for proper assertion, yet they have almost exclusively considered unqualified declaratives. This essay considers the linguistic and normative issues side-by-side. We aim to bring some order and clarity (...) to thinking about hedging, so as to illuminate aspects of interest to both linguists and philosophers. In particular, we consider three broad questions. 1) The structural question: when one hedges, what is the speaker’s commitment weakened from? 2) The functional question: what is the best way to understand how a hedge weakens? And 3) the taxonomic question: are hedged assertions genuine assertions, another speech act, or what? (shrink)