Minimal Risk in Pediatric Research: A Philosophical Review and Reconsideration

Despite more than thirty years of debate, disagreement persists among research ethicists about the most appropriate way to interpret the U.S. regulations on pediatric research, specifically the categories of “minimal risk” and a “minor increase over minimal risk.” Focusing primarily on the definition of “minimal risk,” we argue in this article that the continued debate about the pediatric risk categories is at least partly because their conceptual status is seldom considered directly. Once this is done, it becomes clear that the most popular strategy for interpreting “minimal risk”—defining it as a specific set of risks—is indefensible and, from a pragmatic perspective, unlikely to resolve disagreement. Primarily this is because judgments about minimal risk are both normative and heavily intuitive in nature and thus cannot easily be captured by reductions to a given set of risks. We suggest instead that a more defensible approach to evaluating risk should incorporate room for reflection and deliberation. This dispositional, deliberative framework can nonetheless accommodate a number of intellectual resources for reducing reliance on sheer intuition and improving the quality of risk evaluations.     

The intersection of nonsuicidal self-injury and suicide-related behavior: Patterns of elevated risk and implications for college mental health

Objective: To analyze the overlap of nonsuicidal self-injury (NSSI) and suicide-related behaviors (SRB) among college students with regard to demographics, mental health, and coping styles. Participants: Respondents were 572 undergraduate students at a southwestern public university. Methods: Data were collected in 2015. Respondents completed a demographic survey and assessments of NSSI, SRB, internalizing symptoms (ie, anxiety, stress, and depression), aggression, and negative coping strategies. The survey was administered via a Web-based procedure. Results: Women reported more frequent cutting behaviors than men. Endorsement of NSSI was also associated with an increased likelihood of lifetime SRB. A subgroup of students endorsing both NSSI and SRB demonstrated poorer mental health, more negative coping, and self-reported female sex. Conclusions: College healthcare providers may benefit from competency-based training in techniques for the combination treatment of NSSI and SRB, as well as culturally based models of suicide.     

Gambling,Risk-Taking,and Antisocial Behavior: A Replication Study Supporting the Generality of Deviance

Research suggests that high frequency gambling is a component of the “generality of deviance”, which describes the observation that various forms of risky and antisocial behavior tend to co-occur among individuals. Furthermore, risky and antisocial behaviors have been associated with such personality traits as low self-control, and impulsivity, and sensation-seeking. We conducted a replication (and extension) of two previous studies examining whether high frequency gambling is part of the generality of deviance using a large and diverse community sample (n = 328). This study was conducted as a response to calls for more replication studies in the behavioral and psychological sciences (recent systematic efforts suggest that a significant proportion of psychology studies do not replicate). The results of the present study largely replicate those previously found, and in many cases, we observed stronger associations among measures of gambling, risk-taking, and antisocial behavior in this diverse sample. Together, this study provides evidence for the generality of deviance inclusive of gambling (and, some evidence for the replicability of research relating to gambling and individual differences).     

Southern knowledge online? Climate change research discoverability and communication practices

The networked age promises global digital cultures with flattened power relations, given the affordances of information and communication technologies to collapse distance, enable easier cross-country collaborations and create new opportunities for knowledge production and sharing. In the academic domains, indications are that knowledge patterns continue to reflect physically based geopolitical realities – where knowledge from the South is still peripheral while knowledge from the North still dominates in terms of all the conventional metrics. This study explores the potential role of digital affordances to challenge structural Northern bias and generates questions about knowledge production and dissemination in the climate change knowledge domain. It is framed by the field of scholarly communication within an African setting and by the emergent field of climate change which is fraught with debates and contestations, particularly regarding mitigation and adaptation. It draws on Southern theory which interrogates the global dynamics of knowledge production and dissemination. It explores the intersection of the discoverability and visibility of local climate change research methodologically from the outside in, through an experiment of searches for ‘climate change/South Africa’ and from the inside out by reviewing the online presence of one climate change group in a top-ranked African university.     

‘Power Differences’ and ‘the Power of Difference’: The Dominance of Secularism as Ontological Injustice

Abstract

Recent religious studies and international relations scholarship has highlighted secularism as a critical element in dominant modes of identity, power, and exclusion in global politics. Yet, the implications of these insights for global justice theory and practice have rarely been considered. This article suggests that the current dominance of secularism within global justice theory and practice risks undermining the global justice project. Specifically, I argue that secularism’s dominance constitutes an ontological injustice, where both alternative non-secular visions of the world and visions of alternative non-secular worlds are subordinated to secular ontologies. However, this argument raises a crucial question: if, despite secularism’s claim to neutrality and universality, the dominance of secular ontologies contributes to rather than ameliorates injustice, the question that remains is: what are the alternatives? The article concludes by exploring some preliminary responses to this question.     

Forensic Evaluation of Deaf Individuals: Challenges and Strategies

ABSTRACT

Forensic evaluation of deaf individuals presents unique challenges due to many examinees’ fund of information deficits, potential for language deprivation, and examiners’ frequent lack of creativity regarding communication methods. This article describes challenges most frequently encountered in competency to stand trial and criminal responsibility evaluations and offers strategies for overcoming them. The value of employing multiple communication methods, especially the use of illustrations, is emphasized. Suggestions also are offered regarding preparing evaluation reports and effectively communicating “key deaf fundamentals” to legal personnel. Encouragement is offered for qualified, sign-fluent professionals to engage in forensic work.     

Comparison of dichotomized and distributional approaches in rare event clinical trial design: a fixed Bayesian design

This research was motivated by our goal to design an efficient clinical trial to compare two doses of docosahexaenoic acid supplementation for reducing the rate of earliest preterm births (ePTB) and/or preterm births (PTB). Dichotomizing continuous gestational age (GA) data using a classic binomial distribution will result in a loss of information and reduced power. A distributional approach is an improved strategy to retain statistical power from the continuous distribution. However, appropriate distributions that fit the data properly, particularly in the tails, must be chosen, especially when the data are skewed. A recent study proposed a skew-normal method. We propose a three-component normal mixture model and introduce separate treatment effects at different components of GA. We evaluate operating characteristics of mixture model, beta-binomial model, and skew-normal model through simulation. We also apply these three methods to data from two completed clinical trials from the USA and Australia. Finite mixture models are shown to have favorable properties in PTB analysis but minimal benefit for ePTB analysis. Normal models on log-transformed data have the largest bias. Therefore we recommend finite mixture model for PTB study. Either finite mixture model or beta-binomial model is acceptable for ePTB study.