The article "Picking and Choosing Among Phase I Trials", written by Jill A. Fisher, Torin Monahan and Rebecca L. Walker, was originally published Online First without Open Access. After publication in volume 16, issue 4, page 535-549 the author decided to opt for Open Choice and to make the article an Open Access publication.

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

Learners exposed to an artificial language recognize its abstract structural regularities when instantiated in a novel vocabulary (e.g., Gómez, Gerken, & Schvaneveldt, 2000; Tunney & Altmann, 2001). We asked whether such sensitivity accelerates subsequent learning, and enables acquisition of more complex structure. In Experiment 1, pre-exposure to a category-induction language of the form aX bY sped subsequent learning when the language is instantiated in a different vocabulary. In Experiment 2, while naíve learners did not acquire an acX bcY language, in (...) which aX and bY co-occurrence regularities were separated by a c-element, prior experience with an aX bY language provided some benefit. In Experiment 3 we replicated this finding with a 24-hour delay between learning phases, and controlled for prior experience with the aX bY language's prosodic and phonological characteristics. These findings suggest that learners, and the structure they can acquire, change as a function of experience. (shrink)

Repetitive thinking predicts and maintains depression and anxiety, yet the role of RT in the perinatal context has been under-researched. Further, the content and themes that emerge during RT in the perinatal period have been minimally investigated. We recruited an online community sample of women who had their first baby within the past 12 months. Participants completed a battery of self-report questionnaires which included four open-ended questions about the content of their RT. Responses to the latter were analyzed using an (...) inductive thematic analysis approach. Participants reported RT about a range of unexpected emotional responses to becoming a new mother, impact on their sleep and cognitive functioning, as well as the impact on their identity, sense of self, lifestyle, achievements, and ability to function. RT was commonly experienced in first-time mothers, and the themes that emerged conveyed an overall sense of discrepancy between expectations and reality, as well as adjustment to profound change. By providing insight into the content of RT in new mothers, the findings of our study have scope to inform the content of interventions that seek to prevent and treat postnatal mental health problems, particularly those which target key psychological processes such as RT. (shrink)

Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase (...) 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules. (shrink)

In this exploratory paper, we investigate the extension of Haidt’s :814–834, 2001, The righteous mind: Why good people are divided by politics and religion, 2012) Moral foundations theory, operationalized as the MFQ30 questionnaire, from a sample of the general public across many countries to a sample of business students. MFT posits that people rely on five major concerns, or foundations, when making moral judgments. The five concerns are care/harm, fairness/cheating, loyalty/betrayal, respect/authority, and purity/degradation. In addition, Haidt suggests that intuition, rather (...) than reasoning, leads to moral judgment. We replicate Haidt’s measurement model and find that the measurement model based on our sample is consistent. This indicates support for MFT. Further, we find structural differences in the measurement model between the genders and between areas of study. Our findings suggest that all students in the sample focus substantially on the fairness foundation. Ethics education and research may seek to expand the number of moral foundations individuals consider when discerning whether something is right or wrong. (shrink)

In phase I clinical trials, healthy volunteers are dosed with investigational drugs and subjected to blood draws and other bodily monitoring procedures. In exchange, they are paid. Healthy volunteers are, in a very direct sense, selling access to their bodies for pharmaceutical companies and their associates to run drugs through. In his ethnographic study of socalled professional guinea pigs, Roberto Abadie writes, "Paid volunteers are well aware of the demand for an idealized, perfectly healthy volunteer. They also realize that their (...) body is a valued commodity in clinical trials research". It is perhaps surprising, then, that commodification is little discussed in the bioethics literature on phase I... (shrink)

Cet article est consacré à un emploi singulier des descriptions définies dans la presse people sur Internet. De nombreuses descriptions définies, telles le mari de Jill Biden, pour désigner Joe Biden, et le mari de Melania, pour désigner Donald Trump, y apparaissent sans lien avec le propos des articles, et cela parfois dans des contextes où un pronom personnel serait plus approprié qu’une expression nominale. Nous soulignerons d’abord combien ces descriptions définies s’écartent des emplois ordinaires des expressions référentielles très (...) spécifiées en général et des descriptions définies en particulier et quels risques certaines d’entre elles, relevant de la catégorie des « anaphores présuppositionnelles » de Milner, peuvent présenter pour la bonne interprétation référentielle. Nous spécifierons ensuite leur fonction, fonction liée à la fois à la coloration « people » de ce type de presse et à son support numérique. (shrink)

The development of new effective but expensive medical treatments leads to discussions about whether and how such treatments should be funded in solidarity-based healthcare systems. Solidarity is often seen as an elusive concept; it appears to be used to refer to different sets of concerns, and its interrelations with the concept of justice are not well understood. This paper provides a conceptual analysis of the concept of solidarity as it is used in discussions on the allocation of healthcare resources and (...) the funding of expensive treatments. It contributes to the clarification of the concept of solidarity by identifying in the literature and discussing four uses of the concept: (1) assisting patients in need, (2) upholding the solidarity-based healthcare system, (3) willingness to contribute and (4) promoting equality. It distinguishes normative and descriptive uses of the concept and outlines the overlap and differences between solidarity and justice. Our analysis shows that the various uses of the concept of solidarity point to different, even conflicting, ethical stances on whether and how access to effective, expensive treatments should be provided. We conclude that the concept of solidarity has a role to play in discussions on the accessibility and funding of newly approved medical treatments. It requires, for instance, that healthcare policies promote and maintain both societal willingness to contribute to the care of others and the value of providing care to vulnerable patients through public funding. (shrink)

The development of new effective but expensive medical treatments leads to discussions about whether and how such treatments should be funded in solidarity-based healthcare systems. Solidarity is often seen as an elusive concept; it appears to be used to refer to different sets of concerns, and its interrelations with the concept of justice are not well understood. This paper provides a conceptual analysis of the concept of solidarity as it is used in discussions on the allocation of healthcare resources and (...) the funding of expensive treatments. It contributes to the clarification of the concept of solidarity by identifying in the literature and discussing four uses of the concept: (1) assisting patients in need, (2) upholding the solidarity-based healthcare system, (3) willingness to contribute and (4) promoting equality. It distinguishes normative and descriptive uses of the concept and outlines the overlap and differences between solidarity and justice. Our analysis shows that the various uses of the concept of solidarity point to different, even conflicting, ethical stances on whether and how access to effective, expensive treatments should be provided. We conclude that the concept of solidarity has a role to play in discussions on the accessibility and funding of newly approved medical treatments. It requires, for instance, that healthcare policies promote and maintain both societal willingness to contribute to the care of others and the value of providing care to vulnerable patients through public funding. (shrink)

Background The ethical use both of human and non-human animals in research is predicated on the assumption that it is of a high quality and its projected benefits are more significant than the risks and harms imposed on subjects. Yet questions remain about whether and how IRBs and IACUCs should consider the scientific value of proposed research studies.Methods We draw upon 45 interviews with IRB and IACUC members and researchers with oversight experience about their perceptions of their own roles in (...) reviewing the quality and value of scientific protocols. Interview transcripts were memoed to highlight specific findings, which were then used to identify key themes through an iterative process.Results IRB and IACUC members expressed broad trust in the need for and value of research, and they often assumed that protocols had social value or that prior review, especially when associated with funding, affirmed both the rigor and merit of those protocols. Some oversight members also took an explicit stance against scientific review by stating that such review is not within the regulatory mandates governing their parts in the oversight system. Yet other interviewees expressed uneasiness about the current paradigm for evaluating the quality and overall value of science, suggesting that IRB and IACUC members perceive gaps in the oversight systems.Conclusions These findings reveal many similarities in how IRB and IACUC members understand the roles and limitations of their respective oversight committees. We conclude with a discussion of how the lack of a clear mandate regarding scientific review within US federal regulations may undermine ethical engagement of whether human and animal research is scientifically justified, resulting in a “mission lapse” wherein no organizational body is clearly responsible for ensuring that the research being conducted has the potential to advance science and benefit society. (shrink)

We report the identification of a recurrent, 520-kb 16p12.1 microdeletion associated with childhood developmental delay. The microdeletion was detected in 20 of 11,873 cases compared with 2 of 8,540 controls and replicated in a second series of 22 of 9,254 cases compared with 6 of 6,299 controls. Most deletions were inherited, with carrier parents likely to manifest neuropsychiatric phenotypes compared to non-carrier parents. Probands were more likely to carry an additional large copy-number variant when compared to matched controls. The clinical (...) features of individuals with two mutations were distinct from and/or more severe than those of individuals carrying only the co-occurring mutation. Our data support a two-hit model in which the 16p12.1 microdeletion both predisposes to neuropsychiatric phenotypes as a single event and exacerbates neurodevelopmental phenotypes in association with other large deletions or duplications. Analysis of other microdeletions with variable expressivity indicates that this two-hit model might be more generally applicable to neuropsychiatric disease. © 2010 Nature America, Inc. All rights reserved. (shrink)

Is there a link between how a firm manages its internal and external stakeholders? More specifically, are firms that give employees stock ownership and more say in running the enterprise more likely to engage with external stakeholders? This study seeks to answer these questions by elaborating on mechanisms that link employees to external stakeholders, such as the community, suppliers, and the environment. It tests these relationships using a sample of 347 private, mostly small-to-medium size firms, which completed a stakeholder impact (...) assessment organized by the non-profit B Lab. The results support the hypotheses that both employee ownership and employee involvement are positively associated with external stakeholder engagement. Further, we found that certification plays a role, as employee ownership contributes to external stakeholder engagement only in certified B Corporations, and not in firms that merely completed the B Lab Impact assessment. Our findings have import for stakeholder engagement frameworks, as we show that there is interplay between internal employee stakeholders and external stakeholders that may be important to overall firm–stakeholder management. (shrink)

The expansion of research on deep brain stimulation and adaptive DBS raises important neuroethics and policy questions related to data sharing. However, there has been little empirical research on the perspectives of experts developing these technologies. We conducted semi-structured, open-ended interviews with aDBS researchers regarding their data sharing practices and their perspectives on ethical and policy issues related to sharing. Researchers expressed support for and a commitment to sharing, with most saying that they were either sharing their data or would (...) share in the future and that doing so was important for advancing the field. However, those who are sharing reported a variety of sharing partners, suggesting heterogeneity in sharing practices and lack of the broad sharing that would reflect principles of open science. Researchers described several concerns and barriers related to sharing, including privacy and confidentiality, the usability of shared data by others, ownership and control of data, and limited resources for sharing. They also suggested potential solutions to these challenges, including additional safeguards to address privacy issues, standardization and transparency in analysis to address issues of data usability, professional norms and heightened cooperation to address issues of ownership and control, and streamlining of data transmission to address resource limitations. Researchers also offered a range of views on the sensitivity of neural activity data and data related to mental health in the context of sharing. These findings are an important input to deliberations by researchers, policymakers, neuroethicists, and other stakeholders as they navigate ethics and policy questions related to aDBS research. (shrink)

Historienne, professeure associée à l’Université North Carolina Charlotte, Jill Massino est spécialiste de l’Europe de l’Est, de la Guerre froide, du genre, de l’histoire culturelle et de la mémoire, du socialisme et du postsocialisme. Sa monographie publiée en 2019 s’inscrit dans la continuité d’un volume collectif qu’elle a codirigé avec Shana Penn en 2009 (Gender Politics and Everyday Life in State Socialist Eastern and Central Europe, Palgrave Macmillan) et explore la problématique de la...

Making data broadly accessible is essential to creating a medical information commons. Transparency about data-sharing practices can cultivate trust among prospective and existing MIC participants. We present an analysis of 34 initiatives sharing DNA-derived data based on public information. We describe data-sharing practices captured, including practices related to consent, privacy and security, data access, oversight, and participant engagement. Our results reveal that data-sharing initiatives have some distance to go in achieving transparency.

Business ethics educators strive to produce graduates who not only grasp the principles of ethical decision-making, but who can apply that business ethics education when faced with real-world challenges. However, this has proven especially difficult, as good intentions do not always translate into ethical awareness and action. Complementing a behavioral ethics approach with insights from social psychology, we developed an interventional class module with both online and in-class elements aimed at increasing students’ awareness of their own susceptibility to unconscious biases (...) and, consequently, unethical behaviors. We deployed this intervention within a problem-based learning course, in which students completed real-world projects for actual business clients. Our results suggest that although students appeared universally aware of the importance of ethical issues in business and generally espoused intentions to act ethically, those who received the intervention were significantly more likely to recognize their own susceptibility to perpetuating unethical business behavior and to identify ethical issues specific to their real-world projects. These results have important implications for behavioral ethics pedagogy and provide a de-biasing interventional approach for bridging classroom knowledge with real-world skills. (shrink)

L'A. étudie la théorie classique du jugement telle qu'elle apparait dans «La logique» de A. Arnauld et P. Nicole et oppose la sémantique des termes généraux de Port-Royal à celles de Kant et Frege.

While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of (...) the adverse events they experience during clinical trials. Drawing upon qualitative research, we find that participants largely minimize, deny, or re-attribute the cause of these AEs. We illustrate how participants' interpretations of AEs may be shaped both by the clinical trial environment and their economic motivation to participate. While these narratives are emblematic of the larger ambiguity surrounding harm in the context of clinical trial participation, we argue that these interpretations also problematically maintain the narrative of the safety of clinical trials, the ethics of testing investigational drugs on healthy people, and the rigor of data collected in the specter of such ambiguity. (shrink)

D’après Heidegger, chaque époque/épochè est caractérisé par un certain mode de révélation des étants, qui est à la fois une dissimulation d’une façon de l’Être. Ce mode particulier paraît ne venir de nulle part en ce qu’il se base sur un certain oubli. Dana S. Belu le met en scène pour son livre en faisant valoir la tendance de Heidegger « to treat the history of being (Seinsgeschichte) as a noncausal succession of universal principles of intelligibility that presupposes the forgetting (...) (Seinsvergessenheit) of the clearing (die Lichtung) as their source » (p. 15). L’oubli de notre époque est marqué par une divulgation technologique dans le mode de l’arraisonnement (Gestell) où les étants se révèlent comme partie du fonds (Bestand) d’être calculés, manipulés, exploités, et mis en réserve pour un usage ultérieur. La phénoménologie féministe de l’A. essaie de faire sens à la gestation, la maternité et la procréation médicalement assistée (PMA) qui font aux femmes faire partie de ce fonds et ouvre, parmi les paramètres du Gestell, la porte à une ère « sans mère ». (shrink)

Même si ce livre ne compte pas plus d’une centaine de pages, l’analyse qu’il offre de Heidegger et de sa relation à l’environnement s’avère plutôt exhaustive. Si Casey Rentmeester le fait débuter par une brève histoire du développement de la philosophie environnementale, précisant comment cette discipline a largement affaire à l’éthique appliquée et l’éthique normative, il y explique bientôt comment des philosophes tels que Naess, Thomson et Toadvine emploient aujourd’hui des méthodes non-traditionnelles — ecofeminism, ecophenomenology, deep ecology — pour explorer (...) des aspects négligés par le courant philosophique qui y domine. Avant de s’appuyer sur l’œuvre heideggérienne pour répondre aux questions peu examinées par cette tradition de pensée, l’A. décrit brièvement la manière dont certains des représentants de celle-ci — Siedel, Zimmerman et Foltz notamment — se servent de celle-là pour mieux saisir la position de l’homme dans la nature. À l’en croire, son but est double : utiliser d’abord la critique phénoménologique de la métaphysique établie par Heidegger pour montrer comment, au sein de cette dernière, notre compréhension de l’être a mené à une destruction de l’environnement, puis penser avec Heidegger pour chercher à ce problème une réponse post-métaphysique qu’il s’agirait d’esquisser si tant est qu’il y en ait une. Or, tel est le cas pour Casey Rentmeester, qui se tourne en définitive vers le taoïsme pour lui emprunter son image d’un environnement durable. (shrink)

Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption, involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal decision-making study (...) nested in a Thai acute HIV research cohort. In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks. These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach. (shrink)

Le climat politique actuel en France abonde de débats à propos de l’identité nationale et du voile; en fait, le voile est devenu un symbole séparant l’idée d’une nation française et d’une nation islamique. Cependant, peu d’attention est portée sur la façon dont la perception de la différence de la femme est essentielle à la formation du citoyen français. Au lieu de se demander simplement “que veut dire être Français?” une seconde interrogation devrait suivre sur la façon dont se construit (...) la femme voilée dans la société française. En faisant appel à la philosophie de Hegel, les réflexions philosophiques employées pour ce projet cherchent à poser de nouvelles questions pouvant éclairer le débat sur l’identité nationale: la femme voilée est-elle l’Antigone des temps modernes? Quel est l’enjeu de dévoiler la femme voilée? D’où vient ce désir de la dévoiler? (shrink)