Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms (...) enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)

This volume contains thirteen papers that were presented at the 2017 Annual Meeting of the Canadian Society for History and Philosophy of Mathematics/Société canadienne d’histoire et de philosophie des mathématiques, which was held at Ryerson University in Toronto. It showcases rigorously reviewed modern scholarship on an interesting variety of topics in the history and philosophy of mathematics from Ancient Greece to the twentieth century. A series of chapters all set in the eighteenth century consider topics such as John Marsh’s techniques (...) for the computation of decimal fractions, Euler’s efforts to compute the surface area of scalene cones, a little-known work by John Playfair on the practical aspects of mathematics, and Monge’s use of descriptive geometry. After a brief stop in the nineteenth century to consider the culture of research mathematics in 1860s Prussia, the book moves into the twentieth century with an examination of the historical context within which the Axiom of Choice was developed and a paper discussing Anatoly Vlasov’s adaptation of the Boltzmann equation to ionized gases. The remaining chapters deal with the philosophy of twentieth-century mathematics through topics such as an historically informed discussion of finitism and its limits; a reexamination of Mary Leng’s defenses of mathematical fictionalism through an alternative, anti-realist approach to mathematics; and a look at the reasons that mathematicians select specific problems to pursue. Written by leading scholars in the field, these papers are accessible to not only mathematicians and students of the history and philosophy of mathematics, but also anyone with a general interest in mathematics. (shrink)

The significance of private standards and associated local level initiatives in agri-food value chains are increasingly recognised. However whilst issues related to compliance and impact at the smallholder or worker level have frequently been analysed, the governance implications in terms of how private standards affect national level institutions, public, private and non-governmental, have had less attention. This article applies an extended value chain framework for critical analysis of Private Standards Initiatives (PSIs) in agrifood chains, drawing on primary research on PSIs (...) operating in Kenyan horticulture (Horticulture Ethical Business Initiative and KenyaGAP). The paper explores the legislative, executive and judicial aspects of governance in these southern PSIs highlighting how different stakeholders shape debates and act with agency. It is argued that governance is exercised ‘beyond the vertical’ in that one can identify wider horizontal processes of governance, including how the scope of key debates is constructed (especially in legislative governance) but analysis of executive governance emphasises the dominant role of the lead buyers. (shrink)

Medical legal partnerships address individual legal needs that can create impediments to health. Little is known about outcomes from medical legal partnerships and their relationship to access to justice. This paper reports outcomes from one medical legal partnership from the perspective of the client, with specific emphasis on impact on health and concepts related to access to justice. We suggest a conceptual model for incorporating medical legal partnerships into a broader framework about access to justice.

We apply Benacerraf’s distinction between mathematical ontology and mathematical practice to examine contrasting interpretations of infinitesimal mathematics of the seventeenth and eighteenth century, in the work of Bos, Ferraro, Laugwitz, and others. We detect Weierstrass’s ghost behind some of the received historiography on Euler’s infinitesimal mathematics, as when Ferraro proposes to understand Euler in terms of a Weierstrassian notion of limit and Fraser declares classical analysis to be a “primary point of reference for understanding the eighteenth-century theories.” Meanwhile, scholars like (...) Bos and Laugwitz seek to explore Eulerian methodology, practice, and procedures in a way more faithful to Euler’s own. Euler’s use of infinite integers and the associated infinite products are analyzed in the context of his infinite product decomposition for the sine function. Euler’s principle of cancellation is compared to the Leibnizian transcendental law of homogeneity. The Leibnizian law of continuity similarly finds echoes in Euler. We argue that Ferraro’s assumption that Euler worked with a classical notion of quantity is symptomatic of a post-Weierstrassian placement of Euler in the Archimedean track for the development of analysis, as well as a blurring of the distinction between the dual tracks noted by Bos. Interpreting Euler in an Archimedean conceptual framework obscures important aspects of Euler’s work. Such a framework is profitably replaced by a syntactically more versatile modern infinitesimal framework that provides better proxies for his inferential moves. (shrink)

While there is a significant amount of research investigating managerial ethical judgments, a limited amount examines consumer judgments of unethical corporate behavior and its impact on the marketplace. This study examines how consumers' commitment to a company impacts not only their ethical judgment of corporate behavior but also the outcomes of that judgment. The authors test hypotheses with data from 334 consumers and find that consumers' level of commitment attenuates the level of perceived fairness. More specifically, highly committed consumers may (...) forgive companies for behaviors when perceived harm is low, but become progressively dissatisfied as the level of perceived harm increases. Results of the study point to the importance of considering ethical behavior from a consumer perspective. If corporate actions are perceived as unethical, the company stands to lose favor with their most committed customers. Considering that more time, effort and investment is required to gain a new customer as to retain an old, this study shows that engaging in behavior perceived as unethical by consumers risks alienating the most committed customers. (shrink)

The Toolbox dialogue method enables members of heterogeneous groups to identify, share, and compare their perspectives on topics of common interest, such as research questions or complex problems (Hubbs et al. 2020). These interactions occur in dialogue, typically in relatively brief (eg, two-to four-hour) workshop settings, where participants jointly consider their responses to abstract and often philosophical statements that express positions on the topics. By expressing positions on topics that matter to the group, these statements structure a dialogue that enhances (...) mutual understanding in valuable ways. The method is valuable for heterogeneous groups because it enhances both self-understanding and mutual understanding. It does this by transforming dialogue participants into teachers and learners: teachers of their own perspective to others and learners of the perspectives of others and, to some extent... (shrink)

Moral or ethical questions are vital because they affect our daily lives: what is the best choice we can make, the best action to take in a given situation, and ultimately, the best way to live our lives? Health ethics has contributed to moving ethics toward a more experience-based and user-oriented theoretical and methodological stance but remains in our practice an incomplete lever for human development and flourishing. This context led us to envision and develop the stance of a “living (...) ethics”, described in this inaugural collective and programmatic paper as an effort to consolidate creative collaboration between a wide array of stakeholders. We engaged in a participatory discussion and collective writing process known as instrumentalist concept analysis. This process included initial local consultations, an exploratory literature review, the constitution of a working group of 21 co-authors, and 8 workshops supporting a collaborative thinking and writing process. First, a living ethics designates a stance attentive to human experience and the role played by morality in human existence. Second, a living ethics represents an ongoing effort to interrogate and scrutinize our moral experiences to facilitate adaptation of people and contexts. It promotes the active and inclusive engagement of both individuals and communities in envisioning and enacting scenarios which correspond to their flourishing as authentic ethical agents. Living ethics encourages meaningful participation of stakeholders because moral questions touch deeply upon who we are and who we want to be. We explain various aspects of a living ethics stance, including its theoretical, methodological, and practical implications as well as some barriers to its enactment based on the reflections resulting from the collaborative thinking and writing process. (shrink)

Climate, diet, lifestyle, and environmental settings have all been shown to modulate mood, play a role in mental disorders, and even pose a mental health risk. Can climatotherapy, in its adaptive approach aiming to restore balance among the economic, social, and ecological realms of human societies, situate itself as a therapeutic avenue for the promotion of sustainable mental health?

This book addresses the effects of corruption in Nigeria and provides a concise overview for a lasting solution. Offering insight from the authors' original thinking and experiences, the book traces corruption from colonial rule through nearly fifty years of successive civilian and military government, counter coupes, and ethical reform programs.

The “gift exchange theory” articulated by Marcel Mauss, along with his core concept of a threefold obligation, is the dominant theoretical framework used to explain the majority of gift issues in marketing. This perspective assumes that some interest always lies behind gifts, such that a gift always implies a counterpart of receiving something in return. Despite the relevance of this approach in understanding the day-to-day consumer behavior, this paper presents empirical cases where the consumer is also able to give freely, (...) that is to say without implying a counterpart or even expecting it. To explain those empirical cases, we mobilize a key teaching of the Catholic Church: the “gratuitous gift” and then introduce the concept of the “need to give.” We show that gratuitousness is a relevant concept to understand most of gifts made by consumers, and we develop the normative aspect of gratuitous gift for ethical marketers. We also show that Catholic Social Teaching offers an appropriate anthropology to understand consumer behaviors motivated by this need for gratuitousness. To conclude, we propose further avenues of research. (shrink)

Backround Education in ethics and professionalism should reflect the realities medical students encounter in the hospital and clinic. Method We performed content analyses on Case Observation and Assessments (COAs) written by third-year medical students about ethical and professional issues encountered during their internal medicine and paediatrics clinical clerkships. Results A cohort of 141 third-year medical students wrote 272 COAs. Content analyses identified 35 subcategories of ethical and professional issues within 7 major domains: decisions regarding treatment (31.4%), communication (21.4%), professional duties (...) (18.4%), justice (9.8%), student-specific issues (5.4%), quality of care (3.8%), and miscellaneous (9.8%). Conclusions Students encountered a wide variety of ethical and professional issues that can be used to guide pre-clinical and clinical education. Comparison of our findings with results from similar studies suggests that the wording of an assignment (specifying “ethical” issues, “professional” issues, or both) may influence the kinds of issues students identify in their experience-based clinical narratives. (shrink)

_Changing the Subject_ is a classic critique of traditional psychology in which the foundations of critical and feminist psychology are laid down. Pioneering and foundational, it is still _the _groundbreaking text crucial to furthering the new psychology in both teaching and research. Now reissued with a new foreword describing the changes which have taken place over the last few years, _Changing the Subject _will continue to have a significant impact on thinking about psychology and social theory.

In 2017 and 2018 [Name of research project] organized two transnational youth resistance art workshops. These workshops addressed online social justice issues and placed emphasis on pushing back against technology-facilitated violence and surveillance in networked spaces. Our engagement with these workshops raised three dilemmas associated with these sorts of resistive social justice art projects. This article explores these dilemmas, which include how to enable the production of digital art in a manner that is attentive to intersectional issues of digital literacy (...) and access; artistic appropriations of sexually explicit, discriminatory or hateful speech and their relation to cultural appropriation; and defamation, privacy, copyright and trademark considerations relating to artistic appropriations. In addressing these dilemmas, examples of regulatory frameworks shaping resistance opportunities and social justice initiatives are highlighted, along with suggestions for addressing these dilemmas for those who may wish to facilitate or engage in youth resistance art workshops in future. (shrink)

The lack of gender parity in philosophy has garnered serious attention recently. Previous empirical work that aims to quantify what has come to be called “the gender gap” in philosophy focuses mainly on the absence of women in philosophy faculty and graduate programs. Our study looks at gender representation in philosophy among undergraduate students, undergraduate majors, graduate students, and faculty. Our findings are consistent with what other studies have found about women faculty in philosophy, but we were able to add (...) two pieces of new information. First, the biggest drop in the proportion of women in philosophy occurs between students enrolled in introductory philosophy classes and philosophy majors. Second, this drop is mitigated by the presence of more women philosophy faculty. (shrink)

IntroductionA symptom cluster is very common among oncological patients: cancer-related fatigue, emotional distress, sleep difficulties, pain, and cognitive difficulties. Clinical applications of interventions based on non-ordinary states of consciousness, mostly hypnosis and meditation, are starting to be investigated in oncology settings. They revealed encouraging results in terms of improvements of these symptoms. However, these studies often focused on breast cancer patients, with methodological limitations. Another non-ordinary state of consciousness may also have therapeutic applications in oncology: self-induced cognitive trance. It seems (...) to differ from hypnosis and meditation, as it involves the body more directly. Thus, investigating its clinical applications, along with hypnosis and meditation interventions, could improve available therapeutic options in oncology. This article details the study protocol of a preference-based longitudinal controlled superiority trial aiming to assess the effectiveness of 3 group interventions to improve oncological patients’ quality of life, and more specifically CRF, emotional distress, sleep, pain, and cognitive difficulties.Methods and analysisA power analysis required a total sample of 160 patients. Main inclusion criteria are: cancer diagnosis, active treatments completed for less than a year, no practice of hypnosis, meditation, or SICT, and presence of at least one of these four symptoms: fatigue, sleep difficulties, depression, or anxiety. Each participant will choose the intervention in which they want to participate. To test the effectiveness of the interventions, data will be collected by questionnaires and neurobiological measures and directly from the medical record at four time points: before inclusion in the study ; immediately after the intervention; and at 3- and 12-month follow-up. The longitudinal data in each group will then be measured.DiscussionIn addition to standard cancer therapies, there is a growing interest from patients in complementary approaches, such as hypnosis, meditation, and SICT. The results of this study will be useful to increase knowledge about short- and long-term effectiveness of 3 group interventions for CRF, emotional distress, sleep, pain, and cognitive difficulties in patients with different cancers.Clinical Trial RegistrationClinicalTrials.gov/. Retrospectively registered on the 29th of April 2021. url: https://clinicaltrials.gov/ct2/show/NCT04873661. (shrink)

Background The fourth section of the 1967 Abortion Act states that individuals (including health care practitioners) do not have to participate in an abortion if they have a conscientious objection. A conscientious objection is a refusal to participate in abortion on the grounds of conscience. This may be informed by religious, moral, philosophical, ethical, or personal beliefs. Currently, there is very little investigation into the impact of conscientious objection on service users in Britain. The perspectives of service users are imperative (...) in understanding the real-world consequences and potential impact of conscientious objection and should be considered when creating and reviewing policies and guidelines. This research provided a platform for women and those who can become pregnant to share their experiences and opinions at a time when these voices are largely excluded in the great tradition of Western political philosophy and law-making processes. Method Five service users were interviewed using a narrative interview approach to uncover their abortion journeys and experiences of conscientious objection. Findings The findings were presented as found poems and uncovered that doctors are not always: informing service users that they have a conscientious objection to abortion, giving service users enough information to access abortion (indirect referral), treating them non-judgmentally, and providing medically correct information. Service users did not experience burdens such as long waiting times and were still able to access legal abortion. However, service users did experience negative emotional effects, as they were often left feeling scared, angry, and hopeless when they were not referred and/or were mistreated. Conclusions Findings indicate that conscientious objection could work in practice. However, it is currently failing some individuals on an emotional level, as not all doctors are adhering to guidelines. Conscientious objection in Britain needs to be addressed, to ensure service users receive fair, impartial, non-judgmental care. (shrink)

In an adaptive clinical trial , key trial characteristics may be altered during the course of the trial according to predefined rules in response to information that accumulates within the trial itself. In addition to having distinguishing scientific features, adaptive trials also may involve ethical considerations that differ from more traditional randomized trials. Better understanding of clinical trial experts’ views about the ethical aspects of adaptive designs could assist those planning ACTs. Our aim was to elucidate the opinions of clinical (...) trial experts regarding their beliefs about ethical aspects of ACTs. (shrink)

For the past two decades, agricultural workers in regions of Central America have reported an epidemic of chronic kidney disease of undetermined etiology (CKDu) that is not associated with established risk factors of chronic kidney disease. Several hypotheses have emerged, but the etiology of CKDu remains elusive and controversial. The aim of this literature review was to describe the potential risk factors of CKDu in Mesoamerica and implications for the U.S. agricultural worker population. PubMed and CINAHL databases were searched for (...) articles published between 2000 and 2018 that examined CKDu in Mesoamerica; 29 original studies were included in this review. CKDu is a multifactorial disease that is often asymptomatic with hallmark characteristics of elevated serum creatinine and blood urea nitrogen (BUN), low glomerular filtration rate, electrolyte abnormalities, and non-nephrotic proteinuria. Reducing the global prevalence of CKDu will require more robust studies on causal mechanisms and on interventions that can reduce morbidity and mortality in vulnerable populations. (shrink)

The future of work is forcing the world to adjust to a new paradigm of working. New skills will be required to create and adopt new technology and working methods. Additionally, cognitive skills, particularly creative problem-solving, will be highly sought after. The future of work paradigm has threatened many occupations but bolstered others such as engineering. Engineers must keep up to date with the technological and cognitive demands brought on by the future of work. Using an exploratory mixed-methods approach, our (...) study sought to make sense of how engineers understand and use creative problem solving. We found significant associations between engineers’ implicit knowledge of creativity, exemplified creative problem solving, and the perceived value of creativity. We considered that the work environment is a potential facilitator of creative problem-solving. We used an innovative exceptional cases analysis and found that the highest functioning engineers in terms of knowledge, skills, and perceived value of creativity, also reported working in places that facilitate psychosocially safe environments to support creativity. We propose a new theoretical framework for a creative environment by integrating the Four Ps and psychosocial safety climate theory that management could apply to facilitate creative problem solving. Through the acquisition of knowledge to engage in creative problem solving as individuals or a team, a perception of value must be present to enforce the benefit of creativity to the engineering role. The future of work paradigm requires that organisations provide an environment, a psychosocially safe climate, for engineers to grow and hone their sought-after skills that artificial technologies cannot currently replace. (shrink)

How did the events of the early modern period affect the way gender and the self were represented? This collection of essays attempts to respond to this question by analysing a wide spectrum of cultural concerns - humanism, technology, science, law, anatomy, literacy, domesticity, colonialism, erotic practices, and the theatre - in order to delineate the history of subjectivity and its relationship with the postmodern fragmented subject. The scope of this analysis expands the terrain explored by feminist theory, while its (...) feminist focus reveals that the subject is always gendered - although the terms in which gender is conceived and represented change across history. Feminist Readings of Early Modern Culture not only explores the representation of gendered subjects, but in its commitment to balancing the productive tensions of methodological diversity, also speaks to contemporary challenges facing feminism. (shrink)

Nanotechnologies are a controversial topic, as they seem promising but also cause concern. Previous research has highlighted the potential link between nanotechnologies and other hazardous technologies. The aim of this research was to analyse the discourse on this topic by three groups of participants: laypersons, scientists and environmentalists. Thirty-four people (13 laypersons, ten scientists and eleven environmentalists) were interviewed using a semi-structured interview. Lexical and thematic analyses showed that scientists engage in explanatory discourse and perceive fewer risks than laypersons and (...) environmentalists. The latter two groups describe applications and list the main actors in the development of nanotechnologies. Environmentalists are significantly more likely to make spontaneous associations with other technologies, such as electromagnetic waves, and perceive more risks than the other two groups. Contrary to our expectations, laypersons make fewer associations with biotechnologies than experts or environmentalists. The results are discussed in terms of the interest of a qualitative approach to uncovering new objects spontaneously associated with nanotechnologies, as well as in terms of a risk governance framework. (shrink)

While positive information in the context of clinical care can lead to placebo effects, negatively framed information can have negative or nocebo effects. Extant literature documents how doctor–patient encounters are fertile ground for suboptimal interactions leading to negative experiences for ethnoracial minority patients. In their _JME_ paper, Blease presents a critical perspective on the potential for patients’ access to their doctors’ clinical notes, ‘open notes’, to engender nocebo effects. 1 In this commentary, we affirm the central claim that nocebo effects (...) could emerge ‘via negative wording or framing of health information expressed by clinicians in documentation’. The advent of electronic health records (EHR) allowed patients the unprecedented opportunity to access personal clinical documentation, giving them a window into decision making around their health. This shift is undoubtedly complex, and thus warrants a more fulsome rendering of the unique challenges faced by ethnoracial minority patients. Herein, we highlight three... (shrink)

BackgroundIn Parkinson's disease, the side of motor symptoms onset may influence disease progression, with a faster motor symptom progression in patients with left side lateralization. Moreover, worse neuropsychological outcomes after subthalamic nucleus deep brain stimulation have been described in patients with predominantly left-sided motor symptoms. The objective of this study was to evaluate if the body side of motor symptoms onset may predict motor outcome of bilateral STN-DBS.MethodsThis retrospective study included all consecutive PD patients treated with bilateral STN-DBS at Grenoble (...) University Hospital from 1993 to 2015. Demographic, clinical and neuroimaging data were collected before and 1 year after surgery. The predictive factors of motor outcome at one-year follow-up, measured by the percentage change in the MDS-UPDRS-III score, were evaluated through univariate and multivariate linear regression analysis.ResultsA total of 233 patients were included with one-year follow-up after surgery [143 males ; 121 right body onset; 112 left body onset; mean age at surgery, 55.31 ± 8.44 years; mean disease duration, 11.61 ± 3.87]. Multivariate linear regression analysis showed that the left side of motor symptoms onset did not predict motor outcome.ConclusionsIn this retrospective study, the body side of motor symptoms onset did not significantly influence the one-year motor outcome in a large cohort of PD patients treated with bilateral STN-DBS. (shrink)

BackgroundGiven that advances in research continuously raise new ethical issues, a multidisciplinary working group of investigators involved in biomedical research has gathered to discuss and compare ethical viewpoints in their daily practice.MethodsThe working group has drafted a Charter for Ethics in Biomedical Research that encompasses all the steps in the research process, i.e. from the initial idea to analysis and publication of the results.ResultsBased on key principles for ethically responsible research, the Charter may serve as a tool for performing research, (...) discussing research issues and training researchers.ConclusionsThe Charter should stimulate researchers to think about their responsibility for research in a progressive, caring society. (shrink)