The Declaration of Helsinki and the Council of the International Organization of Medical Sciences provide guidance on standards of care and prevention in clinical trials. In the current and increasingly challenging research environment, the ethical status of a trial design depends not only on protection of participants, but also on social value, feasibility, and scientific validity. Using the example of a study assessing efficacy of a vaccine to prevent human papilloma virus in HIV-1 infected adolescent girls in low resource countries (...) without access to the vaccine, we compare several trial designs which rank lower on some criteria and higher on others, giving rise to difficult trade-offs. This case demonstrates the need for developing more nuanced guidance documents to help researchers balance these often conflicting criteria. (shrink)

Mesenchymal stem cells (MSCs) are present in fat tissues throughout the body, yet little is known regarding their biological role within epidural fat. We hypothesize that debridement of epidural fat and/or subsequent loss of MSCs within this tissue, disrupts homeostasis in the vertebral environment resulting in increased inflammation, fibrosis, and decreased neovascularization leading to poorer functional outcomes post‐injury/operatively. Clinically, epidural fat is commonly considered a space‐filling tissue with limited functionality and therefore typically discarded during surgery. However, the presence of MSCs (...) within epidural fat suggests that itis more biologically active than historically believed and may contribute to the regulation of homeostasis and regeneration in the dural environment. While the current literature supports our hypothesis, it will require additional experimentation to determine if epidural fat is an endogenous driver of repair and regeneration and if so, this tissue should be minimally perturbed from its original location in the spinal canal. Also see the video abstract here https://youtu.be/MIol_IWK1os. (shrink)

Believing that p, assuming that p, and imagining that p involve regarding p as true—or, as we shall call it, accepting p. What distinguishes belief from the other modes of acceptance? We claim that conceiving of an attitude as a belief, rather than an assumption or an instance of imagining, entails conceiving of it as an acceptance that is regulated for truth, while also applying to it the standard of being correct if and only if it is true. We argue (...) that the second half of this claim, according to which the concept of belief includes a standard of correctness, is required to explain the fact that the deliberative question whether to believe that p is transparent to the question whether p. This argument raises various questions. Is there such a thing as deliberating whether to believe? Is the transparency of the deliberative question whether to believe that p the same as the transparency of the factual question whether I do believe that p? We will begin by answering these questions and then turn to a series of possible objections to our argument. (shrink)

BackgroundIn the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort, participants underwent magnetic resonance imaging (MRI) of the brain, heart, and abdomen, that generated incidental findings (IFs). The approach to managing these unexpected results remain a complex issue. Our objectives were to describe the CAHHM policy for the management of IFs, to understand the impact of disclosing IFs to healthy research participants, and to reflect on the ethical obligations of researchers in future MRI studies.MethodsBetween 2013 and 2019, 8252 participants (...) (mean age 58 ± 9 years, 54% women) were recruited with a follow-up questionnaire administered to 909 participants (40% response rate) at 1-year. The CAHHM policy followed a restricted approach, whereby routine feedback on IFs was not provided. Only IFs of severe structural abnormalities were reported.ResultsSevere structural abnormalities occurred in 8.3% (95% confidence interval 7.7–8.9%) of participants, with the highest proportions found in the brain (4.2%) and abdomen (3.1%). The majority of participants (97%) informed of an IF reported no change in quality of life, with 3% of participants reporting that the knowledge of an IF negatively impacted their quality of life. Furthermore, 50% reported increased stress in learning about an IF, and in 95%, the discovery of an IF did not adversely impact his/her life insurance policy. Most participants (90%) would enrol in the study again and perceived the MRI scan to be beneficial, regardless of whether they were informed of IFs. While the implications of a restricted approach to IF management was perceived to be mostly positive, a degree of diagnostic misconception was present amongst participants, indicating the importance of a more thorough consent process to support participant autonomy.ConclusionThe management of IFs from research MRI scans remain a challenging issue, as participants may experience stress and a reduced quality of life when IFs are disclosed. The restricted approach to IF management in CAHHM demonstrated a fair fulfillment of the overarching ethical principles of respect for autonomy, concern for wellbeing, and justice. The approach outlined in the CAHHM policy may serve as a framework for future research studies.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/nct02220582. (shrink)

Nathaniel J.P. Barron offers the first book length account in English of Ernst Bloch's contribution to a Marxist philosophy of language. It is ambitious both in situating Bloch's ideas in the broader Marxist engagement with language as it currently exists, and in using Bloch's utopian categories to challenge that engagement. In particular, Barron reads Voloshinov's insights into language through Bloch's categories, and argues that Bloch advances on Voloshinov by offering an understanding of the social materiality of language which is more (...) useful for challenging fascist forms of utterance. (shrink)

Biomedical research has a strong impact on a country’s scientific-technological and socioeconomic development. It can make a significant contribution at three different levels: promotion of public health; the exchange of knowledge within the scientific community; and economic/ financial profitability. Africa only attracts ~3.3% of the world’s clinical research. This small proportion is due to, among several factors, the absence of two fundamental aspects: specific robust legislation and capacity for regulatory and ethical evaluation. There are five Portuguese- speaking African countries – (...) Angola, Cabo Verde, Guinea-Bissau, Mozambique and São Tomé and Príncipe. Despite presenting different degrees of clinical research development, these countries show a common serious insufficiency in the minimum conditions necessary for hosting, collaborating or leading biomedical research projects. These countries are also excluded from the support of international organisations for capacity building because of the language barrier. The Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese-Speaking African Countries project has developed methods to build capacity and partnership through research on national law, comparisons with international standards and by issuing recommendations at a national level. Through collaborative intensive training, trainees are taught to become educators at a national level. This, in turn, creates a sustainable impact at country level. BERC-Luso is a pioneering project, owing to a combination of innovative features. The partnership project: was developed exclusively in Portuguese; involves a large number of African countries, and national and international institutions; has been further enhanced by the diversity and complementarity of its action plans; and has also benefited from a broad participatory methodology based on resolution of recipients’ problems by the recipients themselves. It thus stands out as a model for similar future projects. (shrink)

In the framework of population dynamics, we start from the logistic equation describing the evolution of one species with limited food supply. A split device allows us to consider the population as two sub-populations x and y evolving analogously. The dynamical system has a one-parameter family of equilibria which is structurally unstable. Then small perturbations of the system (describing functional or ethological differentiations between the sub-species) lead in general to a new system involving a fast and a slow dynamics with (...) a finite number of equilibria. In simple situations where the differentiation is clearly either an advantage or an inconvenience for one of the subspecies, the stable equilibrium amounts to extinction of the disadvantaged subspecies (elementary Darwinism). Oppositely more complex differentiations (involving both advantages and inconveniences) often lead to stable equilibria with well-defined non zero proportions of the sub-populations (preservation of the biodiversity). Other examples are concerned with symbiosis-like differentiations, leading to preservation, whereas the opposite case (mutual nuisances) has an unstable equilibrium and lead to extinction of one or the other subspecies according to the initial conditions. The case of a scission into three subspecies is more rich in consequences. In certain cases, predator-prey relations lead to auto-organization phenomena with stable diversity-preserving diversity. Cases of instability are also possible, leading to orbits tending towards a poly-cycle.This implies some kind of pseudo-extinction: this amounts to “pseudo-periodic-like” orbits with “pseudo-periods” larger and larger, tending to infinity; each pseudo-period contains parts where one of the sub-populations practically vanish. Other non-linear perturbations lead to stable orbits. (shrink)

This book features new perspectives on the ethics and politics of free speech. Contributors draw on insights from philosophy, psychology, political theory, journalism, literature, and history to respond to pressing problems involving free speech in liberal societies. Recent years have seen an explosion of academic interest in free speech. However, most recent work has focused on constitutional protections for free speech and on issues related to academic freedom and campus politics. The chapters in this volume set their sights more broadly (...) on the non-state problems that we collectively face in attempting to realize a healthy environment for free discourse. The volume's contributors share the assumption that threats to free speech do not come exclusively from state sources or bad actors, but from ordinary strategic situations in which all may be acting in good faith. Contributors take seriously the idea that our current cultural moment provides plenty of reason to be concerned about our intellectual climate and offer new insights for how to make things better. New Directions in the Ethics and Politics of Speech will be of interest to researchers and students working in ethics, political philosophy, social theory, and law. (shrink)

While my own philosophical views are largely in keeping with my mentor, Dallas Willard, nevertheless, I find his conception of the human person puzzling, hard to specify precisely, and prima facie contradictory in a few places. Dallas's central goal in formulating his anthropology was to develop a model that shed light on, allowed for deeper insight into, and fostered interest in spiritual formation, especially the role of the body in spiritual maturation. I share this goal, and agree with most of (...) his model. But in what follows, I will make more precise what his views were, try to clear up what, prima facie, seem to be contradictions in his theory, and, finally, recommend an alternative that captures the central concerns Dallas had for his own position. Thus, I will lay out a few general points of Dallas's ontology, provide a description of his philosophical/theological anthropology, along with two problems that seem to be present, and offer a slightly adjusted alternative to his position that accomplishes his main goal in a way with which I believe he would be satisfied. (shrink)

Burgess, J.P. and Rosen, G. Subject with No ObjectElliott, R.Faking Nature.

A leading evangelical thinker offers this brand-new way of addressing life's most important questions: Does God exist, and can we know Him? J.P. Moreland, distinguished professor of philosophy at Talbot School of Theology, abandons traditional didactic apologetics and entices skeptics and dissatisfied believers into a conversation about the emptiness and anxiety so many feel today. He invites them to the abundant life Jesus offers but that so few seem to be experiencing. Moreland shows that people are created by a benevolent (...) God and given a life-enhancing purpose. He empowers readers to... overcome obstacles to faith, including questions about science and religion embrace an enticing view of Jesus and the kingdom of God replace unhelpful images of God with the truth Readers will find practical and effective ways to experience intimacy with God, an effective life of prayer, and a confident hope in life after death. (shrink)