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 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.

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)

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)

SCHOFIELD I, TOLSON D and FLEMING V. Nursing Inquiry 2012; 19: 165–176 [Epub ahead of print]How nurses understand and care for older people with delirium in the acute hospital: a Critical Discourse AnalysisDelirium is a common presentation of deteriorating health in older people. It is potentially deleterious in terms of patient experience and clinical outcomes. Much of what is known about delirium is through positivist research, which forms the evidence base for disease‐based classification systems and clinical guidelines. There is little (...) systematic study of nurses’ day‐to‐day practice of nursing patients with delirium. The aim was to uncover the kinds of knowledge that informs nurses’ care and to explicate the basis of that knowledge. Critical Discourse Analysis is underpinned by the premise that powerful interests within society mediate how social practices are constructed. Links were made between the grammatical and lexical features of nurses’ language about care in interviews and naturalistic settings, and the healthcare context. Care focused on the continuous surveillance of patients with delirium by nurses themselves or vicariously through other patients, and containment. Nurses influenced by major discourses of risk reduction and safety, constructed patients with delirium as risk objects. The philosophy of person‐centred and dignified care advocated in nursing literature and government policy is an emerging discourse, though little evident in the data. The current dominant discourses on safety must give space to discourses of dignity and compassion. (shrink)

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)

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)

BackgroundBiobanks are considered to be key infrastructures for research development and have generated a lot of debate about their ethical, legal and social implications. While the focus has been on human genomic research, rapid advances in human microbiome research further complicate the debate.DiscussionWe draw on two cystic fibrosis biobanks in Toronto, Canada, to illustrate our points. The biobanks have been established to facilitate sample and data sharing for research into the link between disease progression and microbial dynamics in the lungs (...) of pediatric and adult patients. We begin by providing an overview of some of the ELSI associated with human microbiome research, particularly on the implications for the broader society. We then discuss ethical considerations regarding the identifiability of samples biobanked for human microbiome research, and examine the issue of return of results and incidental findings. We argue that, for the purposes of research ethics oversight, human microbiome research samples should be treated with the same privacy considerations as human tissues samples. We also suggest that returning individual microbiome-related findings could provide a powerful clinical tool for care management, but highlight the need for a more grounded understanding of contextual factors that may be unique to human microbiome research.ConclusionsWe revisit the ELSI of biobanking and consider the impact that human microbiome research might have. Our discussion focuses on identifiability of human microbiome research samples, and return of research results and incidental findings for clinical management. (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.

Isolated sleep paralysis is a common parasomnia characterized by an inability to move or speak and often accompanied by hallucinations of a sensed presence nearby. Recent research has linked ISP, and sensed presence more particularly, with social anxiety and other psychopathologies. The present study used a large sample of respondents to an internet questionnaire to test whether these associations are due to a general personality factor, affect distress, which is implicated in nightmare suffering and hypothesized to involve dysfunctional social imagery (...) processes. A new measure, ISP distress, was examined in relation to features of ISP experiences, to self-reported psychopathological diagnosis, to scores on the Leibowitz Social Anxiety Scale and to scores on a new questionnaire subscale assessing social imagery in a variety of waking states. Three main results were found: ISP experiences are only weakly associated with a prior diagnosis of mental disorder, sensed presence during ISP is associated preferentially with ISP distress, and ISP distress is associated with dysfunctional social imagery. A general predisposition to affective distress may influence the distress associated with ISP experiences; overly passive social imagery may, in turn, be implicated in this affect distress influence. (shrink)

Prior research shows that reasoners' confidence is poorly calibrated (Shynkaruk & Thompson, 2006). The goal of the current experiment was to increase calibration in syllogistic reasoning by training reasoners on (a) the concept of logical necessity and (b) the idea that more than one representation of the premises may be possible. Training improved accuracy and was also effective in remedying some systematic misunderstandings about the task: those in the training condition were better at estimating their overall performance than those who (...) were untrained. However, training was less successful in helping reasoners to discriminate which items are most likely to cause them difficulties. In addition we explored other variables that may affect confidence and accuracy, such as the number of models required to represent the problem and whether or not the presented conclusion was necessitated by the premises, possible given the premises, or impossible given the premises. These variables had systematically different relationships to confidence and accuracy. Thus, we propose that confidence in reasoning judgements is analogous to confidence in memory retrievals, in that they are inferentially derived from cues that are not diagnostic in terms of accuracy. (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)

Cet article interroge l’originalité ludique du dispositif sociotechnique conçu par les réseaux socionumériques autour du profil pour organiser les différentes activités en ligne. Alors que les jeux constituent une des activités les plus prisées par les membres du réseau à laquelle ils consacrent un temps important, peu de recherches se sont focalisées sur l’analyse des activités ludiques sur les réseaux socionumériques. Par l’application de cadres conceptuels éprouvés pour analyser les jeux et activités ludiques, il est possible d’interroger la spécificité des (...) modalités de jeux qui sont proposées sur les réseaux socionumériques. Une analyse centrée sur les fonctionnalités offertes par Facebook conduit à interroger de façon critique la nature même de l’activité ludique menée dans le contexte particulier des réseaux socionumériques.This article looks into the distinctively “playful” nature of the socio-technical system that social networking sites construct around user profiles in order to organize different online activities. Although games some of the most popular activities among network members, to which they devote a considerable amount of time, there have been few analyses to date of game-playing on social networking sites. A number of proven conceptual frameworks can be used to analyze online games and game-playing and to examine the particular patterns found on the social networking sites. Based on an analysis of Facebook features, we offer an in-depth discussion of the nature of the game-playing that takes place in the particular context of social networking sites. (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.

:Since the advent of recombinant DNA technology, expectations about the potential for altering genes and controlling our biology at the fundamental level have been sky high. These expectations have gone largely unfulfilled. But though the dream of being able to control our biology is still far off, gene editing research has made enormous strides toward potential clinical use. This paper argues that when it comes to determining permissible uses of gene editing in one important medical context—germline intervention in reproductive medicine—issues (...) about enhancement and eugenics are, for the foreseeable future, a red herring. Current translational goals for gene editing research involve a different kind of editing than would be required to achieve manipulation of complex traits such as intelligence, and there are more pressing questions that need attention if clinical use of gene editing in reproductive medicine ever becomes a possibility. (shrink)

IntroductionIn recent years, there has been something of an explosion of news stories about various college and university campuses across North America experiencing heightened levels of political advocacy and political unrest. Visible examples include the “canceling” of invited speakers who have been deemed offensive by select student groups1 or petitions calling for the removal of instructors who have been accused of using harmful language.2 While these examples shed light on some of the more intense political debates circulating in higher educational (...) institutions, they are also newsworthy stories precisely because they suggest strong divisiveness in worldviews in action—the contradiction between different…. (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)

Background The European Union aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury, aiming to inform and stimulate initiatives to improve efficiency. Methods We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury. (...) Documents included detailed information on IRB procedures and the duration from IRB submission until approval. They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally or locally and primary IRB approval was obtained after one, two or three review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days and appeared to be shorter after submission to local IRBs compared to central IRBs. Conclusion We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries. (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)

This article takes an intergenerational lens to the study of fathers. It draws on evidence from two economic and social research council-funded intergenerational studies of fathers, one of which focused on four-generation British families and the other which included new migrant (Polish) fathers. The article suggests both patterns of change and continuity in fatherhood across the generations. It demonstrates how cultural forces and material conditions need to combine to facilitate change in fathers? exercise of agency and how social class and (...) the conditions of being a migrant shape fathers? practices. It argues that in seeking to recast the public debate about parenting, it is necessary to penetrate below the discursive level of talk about parenting to examine the habitual nature of many family practices, an endeavour to which an intergenerational approach is well suited. This approach enabled us to tease out the horizontal pull of within-generation influences on fathers, the vertical pull of inheritance from older to younger generations and the material and cultural conditions of fathers? current locations, all of which shape their practices. This analysis also alerted us to changes in conceptual language ? not only from fatherhood to fathering ? but also to the historical resilience of the concept of childcare as reserved largely for the role and practices of mothers. (shrink)

Religion is often understood to play a positive role in shaping moral attitudes among believers. We assessed the relationship between church members’ levels of felt connectedness to their respective congregations and perceived similarity in personal and congregational moral values, and whether there was a relationship between these and the amount of time spent in synchronous movement or singing during worship. The similarity between personal and perceived congregational moral importance was correlated with feelings of closeness to one’s congregation but not by (...) the amount of time spent in synchronous movement or singing. Differences in moral foundations scores and in moral importance of specific issues were found between different theological traditions. These findings demonstrate that, for churchgoers, there is a relationship between the use of music or synchronous movement in a church service and feelings of social bonding and there is also a relationship between the degree to which churchgoers identify with their church community and the degree to which they believe their priorities match those of their church. Furthermore, differences in theological tradition appear to be reflected in differences in moral values. (shrink)

Recollections of humanistic and transpersonal psychology’s origin’s morph into the pros and cons of humanistic/transpersonal oriented schools developing APA accredited clinical programs. This discussion dovetails with the question will ATP ever become an APA division, raising an interesting alternative for those of us considering a career in counseling: becoming a spiritual coach. Enter the issue of psychedelic therapy and the Supreme Courts decision to allow ayahuasca as a sacrament by the Uniao Do Vegetal Church, and the importance of why humanistic (...) and transpersonal psychology need to clearly map out the territories and sub-divisions of science and religion. Finally this conversation raises a concern, that Maslow’s call for a “trans-human” psychology sought to encourage creating what we now call ecopsychology. (shrink)

In debates about the moral foundations of intellectual property, one very popular strand concerns the role of labor as a moral basis for intellectual property rights. This idea has a great deal of intuitive plausibility; but is there a way to make it philosophically precise? That is, does labor provide strong reasons to grant intellectual property rights to intellectual laborers? In this paper, I argue that the answer to that question is “yes”. I offer a new view, different from existing (...) labor theories of intellectual property, which I call the productive capacities view. This view gives us a way to make sense of the idea of labor as the basis for intellectual property rights, as well as a tool for critically evaluating existing intellectual property institutions. (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)

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)

A number of roles have been ascribed to poly(ADP‐ribose) polymerase* including involvement in DNA repair, cell proliferation, differentiation and transformation. Cloning of the gene has allowed the development of molecular biological approaches to elucidate the structure and the function(s) of this highly conserved enzyme. This article will review the recent results obtained in this field.

When the accrediting association for collegiate schools of business, AACSB International, reformulated its accreditation standards to include a systematic assessment of undergraduates’ progress in analytic and reflective thinking, our interdisciplinary team looked at available instruments. Logistical problems, concerns about validity, and an interest in assessing quantitative skills not covered in the available instruments led us to devise the Texas Assessment of Critical Thinking Skills™ (TACTS™). As part of the process we followed a suggestion from Scriven and Fisher and incorporated novel (...) multiple-rating items. We went through a lengthy process of test validation, employing both expert consultants and a large-scale comparison between performances on a standard critical thinking skills test and the TACTS™. Consequently, our university is in a position to regularly assess the progress made by undergraduates from our College of Business in acquiring the relevant analytic and reflective thinking skills. (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)