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)

This is the second paper in a two-part series describing subject and family perspectives from the CENTURY-S (CENtral Thalamic Deep Brain Stimulation for the Treatment of Traumatic Brain InjURY-Safety) first-in-human invasive neurological device trial to achieve cognitive restoration in moderate to severe traumatic brain injury (msTBI). To participate, subjects were independently assessed to formally establish decision-making capacity to provide voluntary informed consent. Here, we report on post-operative interviews conducted after a successful trial of thalamic stimulation. All five msTBI subjects met (...) a pre-selected primary endpoint of at least a 10% improvement in completion time on Trail-Making-Test Part B, a marker of executive function. We describe narrative responses of subjects and family members, refracted against that success. Interviews following surgery and the stimulation trial revealed the challenge of adaptation to improvements in cognitive function and emotional regulation as well as altered (and restored) relationships and family dynamics. These improvements exposed barriers to social reintegration made relevant by recoveries once thought inconceivable. The study’s success sparked concerns about post-trial access to implanted devices, financing of device maintenance, battery replacement, and on-going care. Most subjects and families identified the need for supportive counseling to adapt to the new trajectory of their lives. (shrink)

DBS Think Tank IX was held on August 25–27, 2021 in Orlando FL with US based participants largely in person and overseas participants joining by video conferencing technology. The DBS Think Tank was founded in 2012 and provides an open platform where clinicians, engineers and researchers can freely discuss current and emerging deep brain stimulation technologies as well as the logistical and ethical issues facing the field. The consensus among the DBS Think Tank IX speakers was that DBS expanded in (...) its scope and has been applied to multiple brain disorders in an effort to modulate neural circuitry. After collectively sharing our experiences, it was estimated that globally more than 230,000 DBS devices have been implanted for neurological and neuropsychiatric disorders. As such, this year’s meeting was focused on advances in the following areas: neuromodulation in Europe, Asia and Australia; cutting-edge technologies, neuroethics, interventional psychiatry, adaptive DBS, neuromodulation for pain, network neuromodulation for epilepsy and neuromodulation for traumatic brain injury. (shrink)

Hierarchical Bayesian models provide an account of Bayesian inference in a hierarchically structured hypothesis space. Scientific theories are plausibly regarded as organized into hierarchies in many cases, with higher levels sometimes called ‘paradigms’ and lower levels encoding more specific or concrete hypotheses. Therefore, HBMs provide a useful model for scientific theory change, showing how higher-level theory change may be driven by the impact of evidence on lower levels. HBMs capture features described in the Kuhnian tradition, particularly the idea that higher-level (...) theories guide learning at lower levels. In addition, they help resolve certain issues for Bayesians, such as scientific preference for simplicity and the problem of new theories. (shrink)

The ability to extract patterns from sensory input across time and space is thought to underlie the development and acquisition of language and literacy skills, particularly the subdomains marked by the learning of probabilistic knowledge. Thus, impairments in procedural learning are hypothesized to underlie neurodevelopmental disorders, such as dyslexia and developmental language disorder. In the present meta‐analysis, comprising 2396 participants from 39 independent studies, the continuous relationship between language, literacy, and procedural learning on the Serial Reaction Time task (SRTT) was (...) assessed across children and adults with typical development (TD), dyslexia, and Developmental Language Disorder (DLD). Despite a significant, but very small, relationship between procedural learning and overall language and literacy measures, this pattern was not observed at the group‐level when examining TD, dyslexic, and DLD groups separately. Based on the procedural/declarative model, a positive relationship was expected between procedural learning and language and literacy measures for the typically developing group; however, no such relationship was observed. This was also the case for the disordered groups (ps >.05). Also counter to expectations, the magnitude of the relationship between procedural learning and grammar and phonology did not differ between TD and DLD (ps >.05), nor between the TD and dyslexic group on reading, spelling, and phonology (ps >.05). While lending little support to the procedural/declarative model, we consider that these results may be the consequence of poor psychometric properties of the SRTT as a measure of procedural learning. (shrink)

Hyperlink cinema is an emergent film genre that seeks to push the boundaries of the medium in order to mirror contemporary life in the globalized community. Films in the genre thus create an interacting network across space and time in such a way as to suggest that people’s lives can intersect on scales that would not have been possible without modern technologies of travel and communication. This allows us to test the hypothesis that new kinds of media might permit us (...) to break through the natural cognitive constraints that limit the number and quality of social relationships we can manage in the conventional face-to-face world. We used network analysis to test this hypothesis with data from 12 hyperlink films, using 10 motion pictures from a more conventional film genre as a control. We found few differences between hyperlink cinema films and the control genre, and few differences between hyperlink cinema films and either the real world or classical drama (e.g., Shakespeare’s plays). Conversation group size seems to be especially resilient to alteration. It seems that, despite many efficiency advantages, modern media are unable to circumvent the constraints imposed by our evolved psychology. (shrink)

This paper analyses the activities of five organizations shaping the debate over the global governance of genome editing in order to assess current approaches to public engagement (PE). We compare the recommendations of each group with its own practices. All recommend broad engagement with the general public, but their practices vary from expert-driven models dominated by scientists, experts, and civil society groups to citizen deliberation-driven models that feature bidirectional consultation with local citizens, as well as hybrid models that combine elements (...) of both approaches. Only one group practices PE that seeks community perspectives to advance equity. In most cases, PE does little more than record already well-known views held by the most vocal groups, and thus is unlikely to produce more just or equitable processes or policy outcomes. Our exploration of the strengths, weaknesses, and possibilities of current forms of PE suggests a need to rethink both “public” and “engagement.”. (shrink)

This paper introduces the model of Utilitarian Principlism as a framework for crisis healthcare ethics. In modern Western medicine, during non-crisis times, principlism provides the four guiding principles in biomedical ethics—autonomy, nonmaleficence, beneficence, and justice; autonomy typically emerges as the decisive principle. The physician–patient relationship is a deontological construct in which the physician’s primary duty is to the individual patient and the individual patient is paramount. For this reason, we term the non-crisis ethical framework that guides modern medicine Deontological Principlism. (...) During times of crisis, resources become scarce, standards of care become dynamic, and public health ethics move to the forefront. Healthcare providers are forced to work in non-ideal conditions, and interactions with individual patients must be considered in the context of the crisis. The COVID-19 pandemic has forced healthcare to shift to a more utilitarian framework with a greater focus on promoting the health of communities and populations. This paper puts forth the notion of Utilitarian Principlism as a framework for crisis healthcare ethics. We discuss each of the four principles from a utilitarian perspective and use clinical vignettes, based on real cases from the COVID-19 pandemic, for illustrative purposes. We explore how Deontological Principlism and Utilitarian Principlism are two ends of a spectrum, and the implications to healthcare as we emerge from the pandemic. (shrink)

The three important target articles make a strong case for regarding racism as a public health crisis. Each calls for advocacy by the bi...

Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of human (...) subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research. (shrink)

Large-scale sequencing tests, including whole-exome and whole-genome sequencing, are rapidly moving into clinical use. Sequencing is already being used clinically to identify therapeutic opportunities for cancer patients who have run out of conventional treatment options, to help diagnose children with puzzling neurodevelopmental conditions, and to clarify appropriate drug choices and dosing in individuals. To evaluate and support clinical applications of these technologies, the National Human Genome Research Institute and National Cancer Institute have funded studies on clinical and research sequencing under (...) the Clinical Sequencing Exploratory Research program as well as studies on return of results. Most of these studies use sequencing in real-world clinical settings and collect data on both the application of sequencing and the impact of receiving genomic findings on study participants. They are occurring in the context of controversy over how to obtain consent for exome and genome sequencing. (shrink)

Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of human (...) subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research. (shrink)

In much the same way that genomic technologies are changing the complexion of biomedical research, the issues they generate are changing the agenda of IRBs and research ethics. Many of the biggest challenges facing traditional research ethics today — privacy and confidentiality of research subjects; ownership, control, and sharing of research data; return of results and incidental findings; the relevance of group interests and harms; the scope of informed consent; and the relative importance of the therapeutic misconception — have become (...) important policy issues over the last 20 years because of the ways they have been magnified by genomic research efforts. Research that examines the ethical, legal, and social implications of human genomics research has become a burgeoning international field of scholarship over the last 20 years, thanks in part to its support first by the genome research funding bodies in the U.S. and then by national science agencies in other countries. (shrink)

Pylyshyn defends a distinction between early visual perception and cognitive processing. But exactly where should the line between vision and cognition be drawn? Our research on object identification suggests that the construction of an object's visual description is isolated from contextually derived expectations. Moreover, the matching of constructed descriptions to stored descriptions appears to be similarly isolated.

This paper applies Plato's cave allegory to Enron's success and downfall. Plato's famous tale of cave dwellers illustrates the different levels of truth and understanding. These levels include images, the sources of images, and the ultimate reality behind both. The paper first describes these levels of perception as they apply to Plato's cave dwellers and then provides a brief history of the rise of Enron. Then we apply Plato's levels of understanding to Enron, showing how the company created its image (...) and presented information to support that image, and how the public eventually emerged from the cave to realize the truth about Enron's actual accounting practices and financial state, which led to the corporation's downfall. We find Plato's allegory both useful in analyzing the relationship between Enron and the public and instructive about the power and moral responsibility of Enron's executives. (shrink)

This paper applies Plato’s cave allegory to Enron’s success and downfall. Plato’s famous tale of cave dwellers illustrates the different levels of truth and understanding. These levels include images, the sources of images, and the ultimate reality behind both. The paper first describes these levels of perception as they apply to Plato’s cave dwellers and then provides a brief history of the rise of Enron. Then we apply Plato’s levels of understanding to Enron, showing how the company created its image (...) and presented information to support that image, and how the public eventually emerged from the cave to realize the truth about Enron’s actual accounting practices and financial state, which led to the corporation’s downfall. We find Plato’s allegory both useful in analyzing the relationship between Enron and the public and instructive about the power and moral responsibility of Enron’s executives. (shrink)

The number of children with chronic critical illness (CCI) is a growing population in the United States. A defining characteristic of this population is a prolonged hospital stay. Our study assessed the proportion of pediatric patients with chronic critical illness in U.S. hospitals at a specific point in time, and identified a subset of children whose hospital stay lasted for months to years. The potential harms of a prolonged hospitalization for children with CCI, which include over treatment, infection, disruption of (...) family life, and the intensive utilization of resources—combined with the moral distress experienced by the clinicians who care for the children, suggest the need for ethical analysis of this growing issue to identify actions that could be taken at the clinical and health systems levels to reduce the harms associated with prolonged hospital stay.In this article we present three real cases from our study that involved a very long hospital stay. We applied a framework developed by Mackenzie, Rogers, and Dodds to analyze inherent, situational, and pathogenic vulnerabilities to examine the ways that interventions intended to remedy one source of harm for the children in our cohort inadvertently created other harms. We examined the complex ways that children with protracted hospitalization are vulnerable to the choices made by their family and clinicians, as well as by healthcare systems and communities. Finally, we used this analysis to summarize actions and ethical responses to this growing patient population. Such an understanding is essential to making clinical and ethical decisions that arise for children who are at risk for a very long stay in the hospital. (shrink)