Shavelson and colleagues (2023) describe how medical aid-in-dying laws in the United States prohibit assistance in administering aid-in-dying medication. This prohibition distinguishes aid in dying...

Persons with dementia often prefer to participate in decisions about their health care, but may be prevented from doing so because healthcare decision-making law facilitates use of advance directives or surrogate decision makers for persons with decisional impairments such as dementia. Federal and state disability law provide alternative decision-making models that do not prevent persons with mild to moderate dementia from making their own healthcare decisions at the time the decision needs to be made. In order to better promote autonomy (...) and wellbeing, persons with dementia should be accommodated and supported so they can make their own healthcare decisions. (shrink)

Patient narratives from two investigational deep brain stimulation trials for traumatic brain injury and obsessive‐compulsive disorder reveal that injury and illness rob individuals of personal identity and that neuromodulation can restore it. The early success of these interventions makes a compelling case for continued post‐trial access to these technologies. Given the centrality of personal identity to respect for persons, a failure to provide continued access can be understood to represent a metaphorical identity theft. Such a loss recapitulates the pain of (...) an individual's initial injury or illness and becomes especially tragic because it could be prevented by robust policy. A failure to fulfill this normative obligation constitutes a breach of disability law, which would view post‐trial access as a means to achieve social reintegration through this neurotechnological accommodation. (shrink)

Pickering, Newton-Howes, and Young assert that the traditional view of decisional capacity, premised on assessing patients’ abilities to communicate, understand, appreciate,...

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)

Discussion of supported decision making has been dominated by legal scholars, philosophers, and advocates for persons with disabilities. Peterson et al.’s primary contribution is introducing...

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)

Deaths of Despair (DoD), or mortality resulting from suicide, drug overdose, and alcohol-related liver disease, have been rising steadily in the United States over the last several decades. In 2020, a record 186,763 annual despair-related deaths were documented, contributing to the longest sustained decline in US life expectancy since 1915–1918. This forum feature considers how health humanities disciplines might fruitfully engage with this era-defining public health catastrophe and help society better understand and respond to the crisis.

As improvements in neuroscience have enabled a better understanding of disorders of consciousness as well as methods to treat them, a hurdle that has become all too prevalent is the denial of coverage for treatment and rehabilitation services. In 2011, a settlement emerged from a Vermont District Court case, Jimmo v. Sebelius, which was brought to stop the use of an “improvement standard” that required tangible progress over an identifiable period of time for Medicare coverage of services. While the use (...) of this standard can have deleterious effects on those with many chronic conditions, it is especially burdensome for those in the minimally conscious state, where improvements are unpredictable and often not manifested through repeatable overt behaviors. Though the focus of this paper is on the challenges of brain injury and the minimally conscious state, which an estimated 100,000 to 200,000 individuals suffer from in the United States, the post-Jimmo arguments presented can and should have a broad impact as envisioned by the plaintiffs who brought the case on behalf of multiple advocacy groups representing patients with a range of chronic care conditions. (shrink)

Incapacitated adults with a legally appointed guardian or conservator may be recruited for or involved with medical, behavioral, or social science research. Much of the research in which such persons participate is aimed at evaluating medical interventions for them, or contributing to general knowledge about disorders from which they may suffer. In this paper we will consider how the appointment of guardians for patients with disorders of consciousness —severe brain injuries that affect a patient’s level of arousal and ability to (...) interact —impacts such patients’ access to research.Such persons may be under guardianship because they have lost decisional capacity (i.e., those in a coma or... (shrink)

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.

Pullman (2023) compares medically-assisted dying (MAiD) laws and rates of medically-assisted deaths in Canada and California, noting some differences in the legal regime and a higher rate of MAiD i...

McCarthy and Howard (2023) advocate for supported decision making for patients with intellectual and developmental disabilities (IDD). Departing from the “mental prosthesis” model of supported deci...

Although the Federal Common Rule requires that informed consent documents include all material information, it does not specify the content of materials used to recruit human subjects. In particular, there is no federal regulation relating to how payment for research participation is to be advertised. Rather, the FDA has issued guidance, advising researchers not to emphasize payment information. In order to determine how IRBs have interpreted this guidance, we coded the policies of the top 100 institutions by receipt of NIH (...) funding, in order to determine whether they require, permit, or forbid researchers to disclose the amount of compensation in their recruitment materials. We found that the vast majority of institutions implicitly or explicitly permit such disclosures; however, there are a significant number of IRBs at each extreme, some discouraging or forbidding with others encouraging or mandating such disclosures. Such heterogeneity in local regulations suggests that IRB discretion may be imposing costs on human subjects and the scientific enterprise that outweigh the benefits. We suggest that this heterogeneity should be resolved towards a national consensus on permissibility. (shrink)

The payment of human subjects is an area where Institutional Review Boards have wide discretion. Although the “Common Rule” requires the provision of full information to human research participants to secure valid consent, the Rule is silent on the issue of payment. Still, some federal agencies offer guidance on the matter. For example, the National Science Foundation cautions that high payments for risky research “may induce a needy participant to take a risk that they normally would prefer not to take.” (...) For research under its purview, the Food and Drug Administration guidance provides that “[a]dvertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.” One might read the FDA guidance to permit the advertisement for human subjects to state the specific amount of payment, as long as it is not emphasized. (shrink)

In January 2016, Medicare began reimbursing clinicians for time spent engaging in advance care planning with their patients or patients’ surrogates. Such planning involves discussions of the care an individual would want to receive should he or she one day lose the capacity to make health care decisions or have conversations with a surrogate about, for example, end‐of‐life wishes. Clinicians can be reimbursed for face‐to‐face explanation and discussion of care and advance directives and for the completion of advance care planning (...) forms. Although it seems that political barriers to reimbursement for such planning have largely faded, the Medicare policy's impact on provider billing practices appears to be limited, suggesting other barriers to clinician engagement in advance care planning. Additionally, the effects of this policy on patient behavior and the clinician‐patient relationship are not yet known. (shrink)