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)

Society has already seen multiple potential futures of neurotechnologies through the multifaceted lens of science fiction. We do not know which of those futures we will come to live, but the strong force in society's evolutionary process will likely continue to be the insight and oversight developed by the bioethics community, pushing and being pushed by the advances of technology, improvements in medical care, and market competitiveness.

Direct-to-consumer advertising of healthcare products refers to a variety of marketing practices based on a combination of information and promotion strategies directed at consumers through different media such as radio and television broadcasts, newspaper and magazine ads, and, more recently, through the Internet. The principal form of marketing used by the pharmaceutical industry is the distribution of free samples to physicians but DTCA is an increasing part of global promotional spending for prescription drugs. Latest estimates suggest that DTCA now represents (...) an annual $3.2 billion enterprise for the U.S. pharmaceutical industry. Findings from the literature show that these substantial efforts are geared toward the newer pharmaceuticals for chronic conditions with huge market potentials. The lion's share is going to the 20 most prescribed pharmaceuticals. (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)

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)

There is now general agreement about the optionality of scalar implicatures: the pragmatic interpretation will be accessed depending on the context relative to which the utterance is interpreted. The question, then, is what makes a context upper- (vs. lower-) bounding. Neo-Gricean accounts should predict that contexts including factual information will enhance the rate of pragmatic interpretations. Post-Gricean accounts should predict that contexts including psychological attributions will enhance the rate of pragmatic interpretations. We tested two factors using the quantifier scale all, (...) some >: (1) the existence of factual information that facilitates the computation of pragmatic interpretations in the context (here, the cardinality of the domain of quantification) and (2) the fact that the context makes the difference between the semantic and the pragmatic interpretations of the target sentence relevant, involving psychological attributions to the speaker (here a question using all ). We did three experiments, all of which suggest that while cardinality information may be necessary to the computation of the pragmatic interpretation, it plays a minor role in triggering it; highlighting the contrast between the pragmatic and the semantic interpretations, while it is not necessary to the computation of the pragmatic interpretation, strongly mandates a pragmatic interpretation. These results favor Sperber and Wilson's ( 1995 ) post-Gricean account over Chierchia's ( 2013 ) neo-Gricean account. Overall, this suggests that highlighting the relevance of the pragmatic vs. semantic interpretations of the target sentence makes a context upper-bounding. Additionally, the results give a small advantage to the post-Gricean account. (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)

Editor's suggested further reading in BioEssaysA new paradigm in cell therapy for diabetes: Turning pancreatic α‐cells into β‐cells Abstract.

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)

The rational-agent frame of reference for the analysis of corporate strategic decision-making may be expanded to a moral-agent perspective where decision content is seen as comprising both commercial and ethical factors. Relevant factors may then be classified on the basis of the ethical decision principles to which they relate: rational-egoism, self-referential altruism or deontology. This approach is then applied to the problem of decision support for strategic divestment by MNCs.

Qualitative coalitional games (QCGs) were introduced as abstract formal models of goal-oriented cooperative systems. A QCG is a game in which each agent is assumed to have some goal to achieve, and in which agents must typically cooperate with others in order to satisfy their goals. In this paper, we show how it is possible to reason about QCGs using Coalition Logic (CL), a formalism intended to facilitate reasoning about coalitional powers in game-like multiagent systems. We introduce a correspondence relation (...) between QCGs and interpretations for CL, which defines the circumstances under which a CL interpretation correctly characterises a QCG. The complexity of deciding correspondence between QCGs and interpretations for CL is shown to vary from being tractable up to Πp 2-complete, depending on the representation chosen for the QCG and interpretation. We then show how various properties and solution concepts of QCGs can be characterised as CL formula schemes. The ideas are illustrated via a detailed worked example, in which we demonstrate how a model checker can be deployed to investigate whether a particular system has the properties in question. (shrink)

The aim of this research was to gain insight into the experiences and perspectives of individual members of a Medical Research Ethics Committee regarding their individual roles and possible tensions within and between these roles. We conducted a qualitative interview study among members of a large MREC, supplemented by a focus group meeting. Respondents distinguish five roles: protector, facilitator, educator, advisor and assessor. Central to the role of protector is securing valid informed consent and a proper risk-benefit analysis. The role (...) of facilitator implies that respondents want to think along with and assist researchers in order to help medical science progress. As educators, the respondents want to raise ethical and methodological awareness of researchers. The role of advisor implies that respondents bring in their own expertise. The role of assessor points to contributing to the overall evaluation of the research proposal. Various tensions were identified within and between roles. Within the role of protector, a tension is experienced between paternalism and autonomy. Between the role of protector and facilitator tensions occur when the value of a study is questioned while risks and burdens for the subjects are negligible. Within the role of assessor, a tension is felt between the implicit nature of judgments and the need for more explicit formulations. Awareness of various roles and responsibilities may prevent one-sided views on MREC work, not only by members themselves, but also by researchers. Tensions within and between the roles require reflection by MREC members. (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)

Despite the reported limited success of conventional treatments and growing evidence of the effectiveness of adult bariatric surgery, weight loss operations for (morbidly) obese children and adolescents are still considered to be controversial by health care professionals and lay people alike. This paper describes an explorative, qualitative study involving obesity specialists, morbidly obese adolescents, and parents and identifies attitudes and normative beliefs regarding pediatric bariatric surgery. Views on the etiology of obesity—whether it should be considered primarily a medical condition or (...) more a psychosocial problem—seem to affect the specialists’ normative opinions concerning the acceptability of bariatric procedures as a treatment option, the parents’ feelings regarding both being able to influence their child’s health and their child being able to control their own condition, and the adolescents’ sense of competence and motivation for treatment. Moreover, parents and adolescents who saw obesity as something that they could influence themselves were more in favor of non-surgical treatment and vice versa. Conflicting attitudes and normative views—e.g., with regard to concepts of disease, personal influence on health, motivation, and the possibility of a careful informed consent procedure—play an important role in the acceptability of bariatric surgery for childhood obesity. (shrink)

Bundel filosofische voordrachten over de object-kenmerken van voorwerpen van esthetisch welgevallen.

Synthetic biology is an emerging technology that asks for inclusive reflection on how people frame the field. To unravel how we can facilitate such reflection, this study evaluates the Frame Reflection Lab. Building upon playfulness design principles, the FRL comprises a workshop with video-narratives and co-creative group exercises. We studied how the FRL facilitated frame reflection by organizing workshops with various student groups. Analysis of 12 group conversations and 158 mini-exit surveys yielded patterns in first-order reflection as well as patterns (...) in second-order reflection. Also patterns in participants’ framing of synthetic biology could be induced; participants’ viewpoints converged to some extent, yet with openness to individual viewpoint differences. Although the FRL method fortified the reflection processes of participants, the narratives and the workshop’s flexible format could inhibit the reflection too. Therefore, we advise designers of future frame reflection methods to apply stronger conversational facilitation and narratives of slightly mysterious yet identifiable narrators, in case e.g. video-narratives are created and used to scaffold the reflection process. Nevertheless, we argue that the use of a playful frame reflection method like the FRL could function well as a step to precede more application-specific deliberation or decision-making on synthetic biology and as a method for the collection of contemporary citizen viewpoints plus rationales underlying these, for the further responsible development of the emerging field. (shrink)

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)

Research questions and backgroundThis study explores a highly controversial issue of medical care in Germany: the decision to withhold or withdraw mechanical ventilation in critically ill patients. It analyzes difficulties in making these decisions and the physicians’ uncertainty in understanding the German terminology of Sterbehilfe, which is used in the context of treatment limitation. Used in everyday language, the word Sterbehilfe carries connotations such as helping the patient in the dying process or helping the patient to enter the dying process. (...) Yet, in the legal and ethical discourse Sterbehilfe indicates several concepts: (1) treatment limitation, i.e., withholding or withdrawing life-sustaining treatment (passive Sterbehilfe), (2) the use of medication for symptom control while taking into account the risk of hastening the patient’s death (indirekte Sterbehilfe), and (3) measures to deliberately terminate the patient’s life (aktive Sterbehilfe). The terminology of Sterbehilfe has been criticized for being too complex and misleading, particularly for practical purposes. Materials and methods An exploratory study based on qualitative interviews was conducted with 28 physicians from nine medical intensive care units in tertiary care hospitals in the German federal state of Baden-Wuerttemberg. The method of data collection was a problem-centered, semi-structured interview using two authentic clinical case examples. In order to shed light on the relation between the physicians’ concepts and the ethical and legal frames of reference, we analyzed their way of using the terms passive and aktive Sterbehilfe. Results Generally, the physicians were more hesitant in making decisions to withdraw rather than withhold mechanical ventilation. Almost half of them assumed a categorical prohibition to withdraw any mechanical ventilation and more than one third felt that treatment ought not to be withdrawn at all. Physicians showed specific uncertainty about classifying the withdrawal of mechanical ventilation as passive Sterbehilfe, and had difficulties understanding that terminating ventilation is not basically illegal, but the permissibility of withdrawal depends on the situation. Conclusions The physicians’ knowledge and skills in interpreting clinical ethical dilemmas require specific improvement on the one hand; on the other hand, the terms passive and aktive Sterbehilfe are less clear than desirable and not as easy to use in clinical practice. Fear of making unjustified or illegal decisions may motivate physicians to continue (even futile) treatment. Physicians strongly opt for more open discussion about end-of-life care to allow for discontinuation of futile treatment and to reduce conflict. (shrink)

Participatory action research (PAR) is a form of community-driven qualitative research which aims to collaboratively take action to improve participants’ lives. This is generally achieved through cognitive, reflexive learning cycles, whereby people ultimately enhance their wellbeing. This approach builds on two assumptions: (1) participants are able to reflect on and prioritize difficulties they face; (2) collective impetus and action are progressively achieved, ultimately leading to increased wellbeing. This article complicates these assumptions by analyzing a two-year PAR project with mothers of (...) disabled children from a South African urban settlement. Participant observation notes, interviews, and a group discussion served as primary data. We found that mothers’ severe psychological stress and the strong intersectionality of their daily challenges hampered participation. Consequently, mothers considered the project ‘inactionable’. Yet, many women quickly started expressing important individual and collective wellbeing transformations. To understand these ‘unlikely’ transformations, a feminist relational account, in particular, that of relational wellbeing, proves essential. We reflect on the consequences of these findings for the dominant PAR methodology and operationalization, and propose to sensitize future PAR with marginalized women by employing relational wellbeing as an overarching ontological awareness. (shrink)

As of October 23, 2020, almost 42 million cases of COVID-19 have been reported globally. Although many different treatments have been applied in infected...

In their 2007 paper, Swierstra and Rip identify characteristic tropes and patterns of moral argumentation in the debate about the ethics of new and emerging science and technologies (or “NEST-ethics”). Taking their NEST-ethics structure as a starting point, we considered the debate about tissue engineering (TE), and argue what aspects we think ought to be a part of a rich and high-quality debate of TE. The debate surrounding TE seems to be predominantly a debate among experts. When considering the NEST-ethics (...) arguments that deal directly with technology, we can generally conclude that consequentialist arguments are by far the most prominently featured in discussions of TE. In addition, many papers discuss principles, rights and duties relevant to aspects of TE, both in a positive and in a critical sense. Justice arguments are only sporadically made, some “good life” arguments are used, others less so (such as the explicit articulation of perceived limits, or the technology as a technological fix for a social problem). Missing topics in the discussion, at least from the perspective of NEST-ethics, are second “level” arguments—those referring to techno-moral change connected to tissue engineering. Currently, the discussion about tissue engineering mostly focuses on its so-called “hard impacts”—quantifiable risks and benefits of the technology. Its “soft impacts”—effects that cannot easily be quantified, such as changes to experience, habits and perceptions, should receive more attention. (shrink)