Informed Consent for the Human Research Subject with a Neurologic Disorder.

The doctrine of informed consent sits at the intersection of law, ethics, and neuroscience, posing unique challenges for human subject research involving neurological patients. These challenges are compounded by the variegated nature of both neurological injury and the law governing research consent. This article provides a framework for investigators likely to encounter subjects with some degree of neurological impairment, whose capacity to consent requires scrupulous assessment prior to enrollment in research trials. We consider several researches and disease contexts-from emergency epilepsy research to long-term dementia research-and clarify the ethical and legal principles governing consent for participation in each. We additionally explore empirical research on consent capacity and survey several areas of emerging ethical import that will require the attention of investigators in decades to come

Individual differences in level of wisdom are associated with brain activation during a moral decision-making task.

IntroductionWisdom is reportedly associated with better health and quality of life. However, our knowledge of the neurobiology of wisdom is still in the early stages of development. We aimed to improve our understanding by correlating a psychometric measure of the trait with patterns of brain activation produced by a cognitive task theorized to be relevant to wisdom: moral decision-making. In particular, we aimed to determine whether individual differences in wisdom interact with moral task complexity in relation to brain activation.MethodsParticipants were 39 community-dwelling men and women aged 27-76 years, who completed moral and nonmoral decision-making tasks while undergoing functional magnetic resonance imaging. Brain activation in select regions of interest was correlated with participants' scores on the San Diego Wisdom Scale (SD-WISE).ResultsIndividual differences in wisdom were found to interact with brain response to moral versus nonmoral and moral personal versus impersonal dilemmas, particularly in regions in or near the default mode network. Persons with higher scores on the SD-WISE had less contrast between moral and nonmoral dilemmas and greater contrast between moral-personal and moral-impersonal dilemmas than individuals with lower SD-WISE scores.ConclusionsResults confirmed our hypothesis that individual differences in level of wisdom would interact with moral condition in relation to brain activation, and may underscore the relevance of considering one's own and others' actions and experiences in the context of wise thinking. Future studies are needed to replicate these findings and to examine specific neurocircuits

Neuroethics guiding principles for the NIH Brain Initiative

Neuroscience presents important neuroethical considerations. Human neuroscience demands focused application of the core research ethics guidelines set out in documents such as the Belmont Report. Various mechanisms, including institutional review boards (IRBs), privacy rules, and the Food and Drug Administration, regulate many aspects of neuroscience research and many articles, books, workshops, and conferences address neuroethics. (Farah, 2010; https://bioethicsarchive.georgetown.edu/pcsbi/studies.html; http://www.neuroethicssociety.org/annual-meeting). However, responsible neuroscience research requires continual dialogue among neuroscience researchers, ethicists, philosophers, lawyers, and other stakeholders to help assess its ethical, legal, and societal implications. The Neuroethics Working Group of the National Institutes of Health (NIH) Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, a group of experts providing neuroethics input to the NIH BRAIN Initiative Multi-Council Working Group, seeks to promote this dialogue by proposing the following Neuroethics Guiding Principles (Table 1)

Proceedings of the Eighth Annual Deep Brain Stimulation Think Tank: Advances in Optogenetics, Ethical Issues Affecting DBS Research, Neuromodulatory Approaches for Depression, Adaptive Neurostimulation, and Emerging DBS Technologies

We estimate that 208,000 deep brain stimulation (DBS) devices have been implanted to address neurological and neuropsychiatric disorders worldwide. DBS Think Tank presenters pooled data and determined that DBS expanded in its scope and has been applied to multiple brain disorders in an effort to modulate neural circuitry. The DBS Think Tank was founded in 2012 providing a space where clinicians, engineers, researchers from industry and academia discuss current and emerging DBS technologies and logistical and ethical issues facing the field. The emphasis is on cutting edge research and collaboration aimed to advance the DBS field. The Eighth Annual DBS Think Tank was held virtually on September 1 and 2, 2020 (Zoom Video Communications) due to restrictions related to the COVID-19 pandemic. The meeting focused on advances in: (1) optogenetics as a tool for comprehending neurobiology of diseases and on optogenetically-inspired DBS, (2) cutting edge of emerging DBS technologies, (3) ethical issues affecting DBS research and access to care, (4) neuromodulatory approaches for depression, (5) advancing novel hardware, software and imaging methodologies, (6) use of neurophysiological signals in adaptive neurostimulation, and (7) use of more advanced technologies to improve DBS clinical outcomes. There were 178 attendees who participated in a DBS Think Tank survey, which revealed the expansion of DBS into several indications such as obesity, post-traumatic stress disorder, addiction and Alzheimer’s disease. This proceedings summarizes the advances discussed at the Eighth Annual DBS Think Tank