Policymakers need to start considering the impact smart connected toys (SCTs) have on children. Equipped with sensors, data processing capacities, and connectivity, SCTs targeting children increasingly penetrate pervasively personal environments. The network of SCTs forms the Internet of Toys (IoToys) and often increases children's engagement and playtime experience. Unfortunately, this young part of the population and, most of the time, their parents are often unaware of SCTs’ far-reaching capacities and limitations. The capabilities and constraints of SCTs create severe side effects (...) at the technical, individual, and societal level. These side effects are often unforeseeable and unexpected. They arise from the technology's use and the interconnected nature of the IoToys, without necessarily involving malevolence from their creators. Although existing regulations and new ethical guidelines for artificial intelligence provide remedies to address some of the side effects, policymakers did not develop these redress mechanisms having children and SCTs in mind. This article provides an analysis of the arising side effects of SCTs and contrasts them with current regulatory redress mechanisms. We thereby highlight misfits and needs for further policymaking efforts. (shrink)

Policymakers need to start considering the impact smart connected toys (SCTs) have on children. Equipped with sensors, data processing capacities, and connectivity, SCTs targeting children increasingly penetrate pervasively personal environments. The network of SCTs forms the Internet of Toys (IoToys) and often increases children's engagement and playtime experience. Unfortunately, this young part of the population and, most of the time, their parents are often unaware of SCTs’ far-reaching capacities and limitations. The capabilities and constraints of SCTs create severe side effects (...) at the technical, individual, and societal level. These side effects are often unforeseeable and unexpected. They arise from the technology's use and the interconnected nature of the IoToys, without necessarily involving malevolence from their creators. Although existing regulations and new ethical guidelines for artificial intelligence provide remedies to address some of the side effects, policymakers did not develop these redress mechanisms having children and SCTs in mind. This article provides an analysis of the arising side effects of SCTs and contrasts them with current regulatory redress mechanisms. We thereby highlight misfits and needs for further policymaking efforts. (shrink)

In this article we examine the effectiveness of consent in data protection legislation. We argue that the current legal framework for consent, which has its basis in the idea of autonomous authorisation, does not work in practice. In practice the legal requirements for consent lead to ‘consent desensitisation’, undermining privacy protection and trust in data processing. In particular we argue that stricter legal requirements for giving and obtaining consent as proposed in the European Data protection regulation will further weaken the (...) effectiveness of the consent mechanism. Building on Miller and Wertheimer’s ‘Fair Transaction’ model of consent we will examine alternatives to explicit consent. (shrink)

Research on self-agency emphasizes the importance of a comparing mechanism, which scans for a match between anticipated and actual outcomes, in the subjective experience of doing.This study explored the “feeling of doing” in individuals with checking symptoms by examining the mechanism involved in the experienced agency for outcomes that matched expectations. This mechanism was explored using a task in which the subliminal priming of potential action-effects generally enhances people’s feeling of causing these effects when they occur, due to the unconscious (...) perception of a match between primed and observed outcomes. The main result revealed a negative relationship between checking and self-agency for observed outcomes that were primed prior to actions. This suggests that checking individuals fail to grasp the correspondence between actual outcomes of their actions and expected ones. We discuss the possible role of undermined self-agency in checking phenomena and its relationship with cognitive dysfunction. (shrink)

The book in front of you is the first international academic volume on the legal, philosophical and economic aspects of the rise of 3D printing. In recent years 3D printing has become a hot topic. Some claim that it will revolutionize production and mass consumption, enabling consumers to print anything from clothing, automobile parts and guns to various foods, medication and spare parts for their home appliances. This may significantly reduce our environmental footprint, but also offers potential for innovation and (...) creativity. At the same time 3D printing raises social, ethical, regulatory and legal questions. If individuals can print anything they want, how does this affect existing systems of intellectual property rights? What are the societal consequences of the various types of products one can print with a 3D printer, for example weapons? Should all aspects of 3D printing be regulated, and if so, how and to what ends? How will businesses (have to) change their way of working and their revenue model in light of the shift to printing-on-demand? How will the role of product designers change in a world where everyone has the potential to design their own products? These and other questions are addressed in high quality and in-depth contributions by academics and experts, bringing together a wide variety of academic discussions on 3D printing from different disciplines as well as presenting new views, broadening the discussion beyond the merely technical dimension of 3D printing. Bibi van den Berg is Associate Professor at eLaw, the Center for Law and Digital Technologies at Leiden University, The Netherlands. Simone van der Hof is Full Professor at eLaw in Leiden and Eleni Kosta is Associate Professor at TILT, the Tilburg Institute for Law, Technology and Society at Tilburg University, The Netherlands. (shrink)

_Exploration of Alfred North Whitehead's influence on Maurice Merleau-Ponty's ontology of nature._.

This study examined cognitive representations of routine action, through the assessment of level of agency, in individuals with sub-clinical checking. The level of agency stems from Action Identification Theory [Vallacher, R. R., Wegner, D. M. . Levels of personal agency: Individual variation in action identification. Journal of Personality and Social Psychology 57, 660–671], which states that how actions are usually identified reflects the predominant accessibility of internal representation . Furthermore, this framework proposed that altered action regulation is related to low-level (...) of agency . In the current study, the main result indicated that checking symptoms were related to a low-level of agency, that is, individuals with sub-clinical checking identified habitual actions on the basis of instrumental aspects. This seems to indicate that checkers may act with a lack of goal representations. The results are discussed in terms of the role of low-level of agency in checking phenomena and related cognitive dysfunction. (shrink)

Exploration of Alfred North Whitehead's influence on Maurice Merleau-Ponty's ontology of nature.

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two (...) scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. (shrink)

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two (...) scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. (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)

Bijdragen over de actuele betekenis van de filosofie, met name de Reformatorische Wijsbegeerte.

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)

Both the concept of a Darwinian tree of life (TOL) and the possibility of its accurate reconstruction have been much criticized. Criticisms mostly revolve around the extensive occurrence of lateral gene transfer (LGT), instances of uptake of complete organisms to become organelles (with the associated subsequent gene transfer to the nucleus), as well as the implications of more subtle aspects of the biological species concept. Here we argue that none of these criticisms are sufficient to abandon the valuable TOL concept (...) and the biological realities it captures. Especially important is the need to conceptually distinguish between organismal trees and gene trees, which necessitates incorporating insights of widely occurring LGT into modern evolutionary theory. We demonstrate that all criticisms, while based on important new findings, do not invalidate the TOL. After considering the implications of these new insights, we find that the contours of evolution are best represented by a TOL. (shrink)

The precautionary principle is often invoked in relation to pregnant women and may be one of the underlying reasons for their continuous underrepresentation in clinical research. The principle is appealing, because potential fetal harm as a result of research participation is considered to be serious and irreversible. In our paper, we explore through conceptual analysis whether and if so how the precautionary principle should apply to pregnant women. We argue that the principle is a decision-making strategy underlying risk-benefit decisions in (...) clinical research, which can be applied to pregnant women. However, the current application is a strong one, leading to the promotion of absolute exclusion or, less often, absolute inclusion of pregnant women. In order to change this paralyzing situation, a shift toward weak precautionary thinking is necessary. Instead of automatic extreme precaution, a balance will be found between harms and potential benefits of including pregnant women in clinical research. (shrink)

As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as those on fair inclusion and (...) vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change. (shrink)

As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as those on fair inclusion and (...) vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change. (shrink)

Our study presents an overview of the issues that were brought forward by participants of a moral case deliberation (MCD) project in two elderly care organizations. The overview was inductively derived from all case descriptions (N = 202) provided by participants of seven mixed MCD groups, consisting of care providers from various professional backgrounds, from nursing assistant to physician. The MCD groups were part of a larger MCD project within two care institutions (residential homes and nursing homes). Care providers are (...) confronted with a wide variety of largely everyday ethical issues. We distinguished three main categories: ‘resident’s behavior’, ‘divergent perspectives on good care’ and ‘organizational context’. The overview can be used for agendasetting when institutions wish to stimulate reflection and deliberation. It is important that an agenda is constructed from the bottom-up and open to a variety of issues. In addition, organizing reflection and deliberation requires effort to identify moral questions in practice whilst at the same time maintaining the connection with the organizational context and existing communication structures. Once care providers are used to dealing with divergent perspectives, inviting different perspectives (e.g. family members) to take part in the deliberation, might help to identify and address ethical ‘blind spots’. (shrink)

Les décisions politiques sur les risques environnementaux complexes font fréquemment intervenir des éléments scientifiques contestés. Il n’y a généralement pas de « faits » qui conduisent à une politique correcte unique. Les éléments de preuve qui sont intégrés dans les avis scientifiques destinés à une décision politique nécessitent une évaluation de leur qualité. En 2003, l’Agence néerlandaise d’évaluation environnementale a adopté une méthode standardisée, désignée sous le nom de « guide », dans le cadre de laquelle les principaux aspects de (...) la production et de l’utilisation des connaissances sont présentés grâce à une liste de contrôle visant à l’évaluation et à la communication des incertitudes. Dans cet article, nous présentons des résultats de l’application de ce guide à la controverse sur les risques des particules en suspension. La délibération active sur l’incertitude dans un contexte d’expertise entraîne un processus d’apprentissage commun entre les experts et les décideurs politiques, ce qui conduit à une meilleure prise de conscience du phénomène d’incertitude et de ses implications politiques.Policy decisions on complex environmental risks often involve disputed science. Typically, there are no “ facts” to support a single unequivocally correct policy. The evidence provided in scientific studies for policy-making decisions requires high-quality assessment. In 2003, the Netherlands Environmental Assessment Agency adopted a standardized method, referred to as “guidelines”, whereby key quality aspects of knowledge production and use are presented in the form of a checklist for uncertainty assessments and communication. In this article, we present the outcomes of applying the guidelines in controversies on the risks of ambient particulate matter. In the policy–advisory context, active deliberation on uncertainty produces a common learning process for advisors and policy makers, which leads to a deeper understanding and increased awareness of the phenomenon of uncertainty and its policy implications. (shrink)

Moral case deliberation (MCD) is a specific form of clinical ethics, aiming to stimulate ethical reflection in daily practice in order to improve the quality of care. This article focuses on the implementation of MCD in nursing homes and the questions how and where to organize MCD. The purpose of this study was to evaluate one way of organizing MCD in two Dutch nursing homes. In both of these nursing homes the MCD groups had a heterogeneous composition and were organized (...) apart from existing institutional communication structures. As part of a naturalistic evaluation, systematic observations, interviews and focus groups were completed. The findings indicate that the heterogeneous composition and MCD meetings separate from existing structures have benefits. However, the participants also reported negative experiences. This gives rise to the question whether a mixed MCD group which meets separately is an effective way to embed MCD as an instrument for reflection on moral issues in daily practice. We conclude that there is no single answer to that question. In the end, the two implementation strategies (i.e. within existing communication structures and a mixed MCD group) can be complementary to each other. (shrink)

Masters Thesis -- Stellenbosch University, 2019.

BackgroundThere 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.MethodsWe 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.ResultsThree 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.ConclusionsHealthcare 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)

Everybody knows the phenomena summarized with the term attention: concentration, focalization, limitation, selection, and intensification. The explanation of these phenomena is, however, a different matter. Problems easily arise with regard towhathas to be explained and with regard to thestyleof explanation. A problem of the first kind is the “methodology of ‘bad focus’”: the explanation starts with and is fixated on an intuitively striking but nonessential behavioral feature or cognitive achievement. A problem of the second kind is a “virtus dormitiva” explanation: (...) the explanation starts with emphasizing one aspect of the observed phenomena, the emphasized aspect receives an interesting and suggestive name, and that name with its connotations is used as a concept in the explanation. At the start of contemporary, behavior-based, information processing psychology, avirtus dormitivaexplanation infiltrated the functional accounts of the phenomena of attention; the empirical observation that people show performance limitations was translated into the theoretical concept of a communication channel with a limited capacity. That limited capacity notion became the core concept in what can be called the standard theory of attention. This standard theory of attention faced severe difficulties in explaining the guidance of attention by the information processor's goals and intentions. Subsequent modifications, concerned with removing these difficulties, revealed that selection, guided by goals and intentions, is the essential behavioral feature and that the observed performance limitations are a result of this selection. So, the limited capacity theorizing was not only plagued by avirtus dormitivaexplanation, it also suffered from the methodology of bad focus. (shrink)

This book puts forward a new theoretical concept of the juridical act, this concept is not described from the perspective of a specific national legal system, but instead represents the commonalities and ideas that stem from the Western legal tradition. Since the concept is system-independent, it does not rely on national or state laws. The book begins by detailing those characteristics that distinguish juridical acts from the general group of acts. It offers clear distinctions between the different aspects of juridical (...) acts, such as the power and the competence needed in order to perform the act, the fact that juridical acts are constitutive speech acts, and the rules that connect the act with its consequences. In the process, the book dispels much of the haziness currently surrounding juridical acts. Developed with a mix of theory and practice, this new concept is better equipped to deal with modern trends and practices. Further, since the author has freed the idea of the juridical act from the bonds of history and geography, it is also more suited to facilitating a better understanding of and explaining changes in the legal landscape, such as the rise of computer technology. Accordingly, it offers scholars and practitioners alike a valuable new tool for explaining and theorizing about the law. (shrink)

Iris van der Tuin redirects the notion of generational logic in feminism away from its simplistic conception as conflict towards a more nuanced conception of the methodology's useful structures. Experimenting with generational logic as an impetus for a new materialism, this book advances feminist politics for the twenty-first century.

A brain-computer interface technology that can decode the neural signals associated with attempted but unarticulated speech could offer a future efficient means of communication for people with severe motor impairments. Recent demonstrations have validated this approach. Here we assume that it will be possible in future to decode imagined (i.e., attempted but unarticulated) speech in people with severe motor impairments, and we consider the characteristics that could maximize the social utility of a BCI for communication. As a social interaction, communication (...) involves the needs and goals of both speaker and listener, particularly in contexts that have significant potential consequences. We explore three high-consequence legal situations in which neurally-decoded speech could have implications:Testimony, where decoded speech is used as evidence;Consent and Capacity, where it may be used as a means of agency and participation such as consent to medical treatment; andHarm, where such communications may be networked or may cause harm to others. We then illustrate how design choices might impact the social and legal acceptability of these technologies. (shrink)