Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of (...) research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance. (shrink)

Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.

Humans routinely modify their walking speed to adapt to functional goals and physical demands. However, damage to the central nervous system often results in abnormal modulation of walking speed and increased risk of falls. There is considerable interest in treatment modalities that can provide safe and salient training opportunities, feedback about walking performance, and that may augment less reliable sensory feedback within the CNS after injury or disease. Fully immersive virtual reality technologies show benefits in boosting training-related gains in walking (...) performance; however, they lack views of the real world that may limit functional carryover. Augmented reality and mixed reality head-mount displays provide partially immersive environments to extend the virtual reality benefits of interacting with virtual objects but within an unobstructed view of the real world. Despite this potential advantage, the feasibility of using MR-HMD visual feedback to promote goal-directed changes in overground walking speed remains unclear. Thus, we developed and evaluated a novel mixed reality application using the Microsoft HoloLens MR-HMD that provided real-time walking speed targets and augmented visual feedback during overground walking. We tested the application in a group of adults not living with disability and examined if they could use the targets and visual feedback to walk at 85%, 100%, and 115% of each individual’s self-selected speed. We examined whether individuals were able to meet each target gait speed and explored differences in accuracy across repeated trials and at the different speeds. Additionally, given the importance of task-specificity to therapeutic interventions, we examined if walking speed adjustment strategies were consistent with those observed during usual overground walking, and if walking with the MR-HMD resulted in increased variability in gait parameters. Overall, participants matched their overground walking speed to the target speed of the MR-HMD visual feedback conditions. The percent inaccuracy was approximately 5% across all speed matching conditions and remained consistent across walking trials after the first overall walking trial. Walking with the MR-HMD did not result in more variability in walking speed, however, we observed more variability in stride length and time when walking with feedback from the MR-HMD compared to walking without feedback. The findings offer support for mixed reality-based visual feedback as a method to provoke goal-specific changes in overground walking behavior. Further studies are necessary to determine the clinical safety and efficacy of this MR-HMD technology to provide extrinsic sensory feedback in combination with traditional treatments in rehabilitation. (shrink)

The legal risks associated with health research involving human subjects have been highlighted recently by a number of lawsuits launched against those involved in conducting and evaluating the research. Some of these cases have been fully addressed by the legal system, resulting in judgments that provide some guidance. The vast majority of cases have either settled before going to trial, or have not yet been addressed by the courts, leaving us to wonder what might have been and what guidance future (...) cases may bring. What is striking about the lawsuits that have been commenced is the broad range of individuals/institutions that are named as defendants and the broad range of allegations that are made. The research community should take this early experience as a warning and should reflect carefully on practices where research involving human subjects is concerned. (shrink)

Analysis and case studies show that including different orientations toward the natural world makes for more effective scientific practice and science education.

As clinical trials end, little is understood about how participants exiting from clinical trials approach decisions related to the removal or post-trial use of investigational brain implants, such as deep brain stimulation (DBS) devices. This empirical bioethics study examines how research participants experience the process of exit from research at the end of clinical trials of implanted neural devices. Using a modified grounded theory study design, we conducted semi-structured, in-depth interviews with 16 former research participants from clinical trials of DBS (...) and responsive neurostimulation (RNS). Open-ended questions elicited motivations for joining the trial, understanding of study procedures at the time of initial informed consent, the process of exiting from research, and decisions about device removal or post-trial device use. Thematic analysis identified categories related to: limited preparedness for the end of research participation, straightforwardness of decisions to explant or keep the device, reconciling with the end of research participation, reconciling post-trial expectations, and achieving a sense of closure after exit from research. A preliminary theoretical model describes contextual factors influencing the process and experience of exit from research. Experiences of clinical trial participants should guide research practices to enhance the ethical design and conduct of clinical trials in DBS and other brain devices. (shrink)

David E. Over is a leading cognitive scientist and, with his firm grounding in philosophical logic, he also exerts a powerful influence on the psychology of reasoning. He is responsible for not only a large body of empirical work and accompanying theory, but for advancing a major shift in thinking about reasoning, commonly known as the ‘new paradigm’ in the psychology of human reasoning. -/- Over’s signature mix of philosophical logic and experimental psychology has inspired generations of researchers, psychologists, and (...) philosophers alike over more than a quarter of a century. The chapters in this volume, written by a leading group of contributors including a number who helped shape the psychology of reasoning as we know it today, each take their starting point from the key themes of Over’s ground-breaking work. The essays in this collection explore a wide range of central topics—such as rationality, bias, dual processes, and dual systems—as well as contemporary psychological and philosophical theories of conditionals. It concludes with an engaging new chapter, authored by David E. Over himself, which details and analyses the new paradigm psychology of reasoning. -/- This book is therefore important reading for scholars, researchers, and advanced students in psychology, philosophy, and the cognitive sciences, including those who are not familiar with Over’s thought already. (shrink)

The aim of this article is to explore how the brief history of drone warfare thus far affects and potentially alters the parameters of ad bellum and in bello just war principles.

This is the first article in a two-part series describing subject and family perspectives from the central thalamic deep brain stimulation for the treatment of traumatic brain injury using the Medtronic PC + S first-in-human invasive neurological device trial to achieve cognitive restoration in moderate to severe traumatic brain injury, with subjects who were deemed capable of providing voluntary informed consent. In this article, we report on interviews conducted prior to surgery wherein we asked participants about their experiences recovering from (...) brain injury and their perspectives on study enrollment and participation. We asked how risks and benefits were weighed, what their expectations and fears were, and how decisions were reached about trial participation. We found that informed consent and enrollment decisions are fraught. Subjects and families were often split, with subjects more focused on putative benefits and families concerned about incremental risk. Both subjects and families viewed brain injury as disruptive to personal identity and relationships. As decisions were made about study enrollment, families struggled with recognizing the re-emergent agency of subjects and ceding decision-making authority to subjects who had previously been dependent upon them for protection and guidance. Subjects and family members reported a hope for the relief of cognitive disabilities, improved quality of life, normalization of interpersonal interactions, and a return to work or school as reasons for study participation, along with altruism and a desire to advance science. Despite these aspirations, both subjects and families appreciated the risks of the intervention and did not suffer from a therapeutic misconception. A second essay to be published in the next issue of Cambridge Quarterly of Healthcare Ethics—Clinical Neuroethics will describe interviews conducted after surgery, the effects of cognitive restoration for subjects, families, and challenges presented to the social structures they will call upon to support them through recovery. This subsequent article will be available online prior to its formal publication in October 2023. (shrink)

Alan of Lille was a notable figure in the second half of the twelfth century as a theologian and as a poet and he has seemed as rich and individual a writer to modern scholars as he did to his own contemporaries. This study examines his work as a whole, in an attempt to set his well-known literary achievement in the context of his theological writings. He was in many ways a pioneer, an experimenter with several of the new genres (...) of his day, an innovator both as a teacher and as an author. He was not an original thinker so much as an eclectic, drawing on a wide range of the sources available to his contemporaries. He shows us what might be done by a lively-minded scholar with the resources of the day, within the schools of late twelfth-century France, to bring theology alive and make it interesting and challenging to his readers. (shrink)

In their article, Navin, Brummett, and Wasserman (2022) advance the idea that there are qualitatively different types of decision-making capacity (DMC) for treatment refusals. Departing from what t...

We are grateful to Friesen and colleagues for drawing attention to the tension between the protection of populations that may experience vulnerability with their inclusion in research (Friesen et a...

For hundreds of years English people have claimed that fair play is at the core of their national identity. Jonathan Duke-Evans looks at the history of fair play in Britain from earliest times to the present, asking whether it is in fact a British, or alternatively an English, characteristic at all - and if so, whether fair play still matters today? In An English Tradition?, Jonathan Duke-Evans explores the origins of the idea of fair play, tracing it back (...) to the classical world and the Dark Ages, and finding its genesis deep within England's social structure. Charting its early development through both the tales of chivalry and the stories of popular legend, the book shows how fair play manifested itself in literature, the law, the Christian religion, and the family. It examines the way in which fair play was conceived during the ages of slavery and empire, and it proposes a new account of the birth of modern sport in the encounter between age-old popular games and the Victorian cult of amateurism. Taking in the Scottish, Irish, and Welsh manifestations of fair play, Duke-Evans offers contrasts and comparisons from cultures all around the world, and suggests new perspectives on the relevance of fair play in the twenty-first century. (shrink)

This book of twelve essays applies the holistic theories of process philosophy to the educational challenges that teachers face in today's complexly changing world. Topics range from staff development to spirituality, exploring issues of student and teacher motivation, developmental stages of learning, imaginative thinking and writing, nourishing relationships, moral and environmental education, and the development of hospitable learning environments.

Discussions of moral weakness in recent and even not so recent ethics have generally neglected large areas of the moral life. In some cases, it may be argued, such neglect has been accidental in that the philosopher or philosophers concerned have set out to examine problems thrown up by a class or classes of actions without purporting to present an exhaustive account of moral weakness. In other cases such neglect is pernicious in that if not designed to protect a certain (...) philosophical position it has by the doctrinaire delimitation of the range of examples considered had precisely that effect. This delimitation has often arisen out of unexamined presuppositions as to the nature of moral weakness. They are embodied in the following general framework suggested as an account not of some cases of weakness but of all cases: In a case of weakness a man does something that he knows or believes he should not do, or fails to do something that he knows or believes he should do, when the occasion and the opportunity for acting or refraining is present, and when it is in his power, in some significant sense, to act in accordance with his knowledge or belief. (shrink)