Brain injury, medical progress, and the disability paradox: Towards an Americans with Abilities Act.

It is helpful to think about the needs of patients with moderate to severe brain injury through the lens of disability law. However, there are limitations to current disability law that contribute to ongoing segregation and marginalization of individuals with severe brain injury. Indeed, one of the paradoxes of American jurisprudence is that more clear constitutional protections accrue to those who have definitively immutable conditions. Thus, as neuroscience brings new therapies to those with brain injury, they may become less protected by the constitutional elements of disability law because their conditions have changed and become mutable. This is the clinical progress that brain injury professionals all seek to achieve, but ironically these advances could potentially degrade the legal protections of patients who benefit from emerging treatments. In this paper, we will critically examine this paradox at the interface of medicine and the law and suggest that the Americans with Disabilities Act (ADA) could be nicely complemented by legislation we have named the Americans with Abilities Act (AWAA). Instead of focusing on disabilities that need protection, the AWAA seeks to sustain and foster newfound abilities made possible by the fruits of medicine and neuroscience.

The Scholarly and Pedagogical Benefits of the Legal Laboratory: Lessons from the Consortium for the Advanced Study of Brain Injury at Yale Law School.

In our article, we share the lessons we have learned after creating and running a successful legal laboratory over the past seven years at Yale Law School. Our legal laboratory, which focuses on the intersection of law and severe brain injury, represents a unique pedagogical model for legal academia, and is closely influenced by the biomedical laboratory.

Phases of a Pandemic Surge: The Experience of an Ethics Service in New York City during COVID-19.

When the COVID-19 surge hit New York City hospitals, the Division of Medical Ethics at Weill Cornell Medical College, and our affiliated ethics consultation services, faced waves of ethical issues sweeping forward with intensity and urgency. In this article, we describe our experience over an eight-week period (16 March through 10 May 2020), and describe three types of services: clinical ethics consultation (CEC); service practice communications/interventions (SPCI); and organizational ethics advisement (OEA). We tell this narrative through the prism of time, describing the evolution of ethical issues and trends as the pandemic unfolded. We delineate three phases: anticipation and preparation, crisis management, and reflection and adjustment. The first phase focused predominantly on ways to address impending resource shortages and to plan for remote ethics consultation, and CECs focused on code status discussions with surrogates. The second phase was characterized by the dramatic convergence of a rapid increase in the number of critically ill patients, a growing scarcity of resources, and the reassignment/redeployment of staff outside their specialty areas. The third phase was characterized by the recognition that while the worst of the crisis was waning, its medium- and long-term consequences continued to pose immense challenges. We note that there were times during the crisis that serving in the role of clinical ethics consultant created a sense of dis-ease as novel as the coronavirus itself. In retrospect we learned that our activities far exceeded the familiar terrain of clinical ethics consultation and extended into other spheres of organizational life in novel ways that were unanticipated before this pandemic. To that end, we defined and categorized a middle level of ethics consultation, which we have termed service practice communication intervention (SPCI). This is an underappreciated dimension of the work that ethics consult services are capable of in times of crisis. We believe that the pandemic has revealed the many enduring ways that ethics consultation services can more robustly contribute to the ethical life of their institutions moving forward.

Ethical Issues in Contemporary Clinical Genetics.

As genetic sequencing capabilities become more powerful and costs decline, the reach of genomics is expanding beyond research laboratories to the wards, outpatient clinics, and, with the marketing of direct-to-consumer testing services, patients' homes. Increasingly, patients receiving various diagnoses-from cancer to cardiomyopathy-can reasonably expect to have conversations with their providers about indications for genetic testing. In this dynamic context, a grasp of the ethical principles and history underlying clinical genetics will provide clinicians with the tools to guide their practice and help patients navigate complex medical-psychosocial terrain. This article provides an overview of the salient ethical concerns pertaining to clinical genetics. The subject is approached with an emphasis on clinical practice, but consideration is also given to research. The review is organized around the temporal and informational sequence of issues commonly arising during the course of pretesting, testing, and posttesting phases of patient care. Drawing from medical, legal, and historical perspectives, this review covers the following topics: (1) informed consent, (2) return of results, and (3) privacy and confidentiality, and intends to equip readers with an appropriate foundation to apply ethical principles to genetic testing paradigms with an understanding of the contextual landscape against which these situations occur.

Bioethics in the law.

The role of law in bioethics is clear. Laws are enforcement tools: they govern which conditions qualify an individual for disability benefits, or what oversight is necessary for clinical trial protocols, or how patent applications for medical devices should be regulated. I initially studied the law in order to enhance my work in bioethics, but in examining how the law works, I have become convinced that the converse opportunity also exists: there are many areas of law that would benefit from greater input from those in the bioethics community.

Concussions and youth football: using a public health law framework to head off a potential public health crisis.

Concussion from sport is increasingly recognized as a public health priority. In response, all states and the District of Columbia have enacted youth concussion legislation. This paper first examines key developments in concussion-related policy and legislation and then uses the findings from recent scientific studies to highlight the need to incorporate evolving scientific evidence into concussion legislation in order to better protect youth and adolescent athletes. Next, the paper discusses the framework of empirical health law research and why it should be applied in the case of concussion legislation. Finally, this paper argues that empirical health law research should be considered in any decision about whether legislation can help improve the health and safety of young players, a particularly vulnerable population whose unique needs have not yet been adequately addressed.

Deep brain stimulation, brain maps and personalized medicine: lessons from the human genome project.

Although the appellation of personalized medicine is generally attributed to advanced therapeutics in molecular medicine, deep brain stimulation (DBS) can also be so categorized. Like its medical counterpart, DBS is a highly personalized intervention that needs to be tailored to a patient's individual anatomy. And because of this, DBS like more conventional personalized medicine, can be highly specific where the object of care is an N = 1. But that is where the similarities end. Besides their differing medical and surgical provenances, these two varieties of personalized medicine have had strikingly different impacts. The molecular variant, though of a more recent vintage has thrived and is experiencing explosive growth, while DBS still struggles to find a sustainable therapeutic niche. Despite its promise, and success as a vetted treatment for drug resistant Parkinson's Disease, DBS has lagged in broadening its development, often encountering regulatory hurdles and financial barriers necessary to mount an adequate number of quality trials. In this paper we will consider why DBS-or better yet neuromodulation-has encountered these challenges and contrast this experience with the more successful advance of personalized medicine. We will suggest that personalized medicine and DBS's differential performance can be explained as a matter of timing and complexity. We believe that DBS has struggled because it has been a journey of scientific exploration conducted without a map. In contrast to molecular personalized medicine which followed the mapping of the human genome and the Human Genome Project, DBS preceded plans for the mapping of the human brain. We believe that this sequence has given personalized medicine a distinct advantage and that the fullest potential of DBS will be realized both as a cartographical or electrophysiological probe and as a modality of personalized medicine.

Neuroimaging and neuroethics: clinical and policy considerations.

PURPOSE OF REVIEW: Neuroimaging is providing a window on severe brain injury and mechanisms of recovery in patients with consciousness disorders. This brief essay will consider the ethical implications of these developments for clinical diagnosis, emerging therapeutics and health policy. RECENT FINDINGS: Over the past year, functional imaging has led to two dramatic findings with the potential to alter how clinicians categorize severe brain injury and understand mechanisms of recovery. One paper reported a neuroimaging response in a patient who was behaviorally in the vegetative state. Another described structural changes in a patient with late emergence from the minimally conscious state. SUMMARY: Research into functional imaging and disorders of consciousness have the potential to elucidate mechanisms of brain recovery and refine their diagnostic nosology. These distinctions are becoming increasingly important given the potential of emerging therapeutic approaches to the minimally conscious state. Despite this promise the refinement of descriptive categories such as the vegetative and minimally conscious states is not without some degree of peril. Investigators and clinicians need to appreciate the uncertainty that will be engendered as diagnostic categories are redrawn and resist the premature dissemination of neuroimaging technology before its ethical implications for clinical practice are well understood.