Marshall and colleagues (2024) contribute to the literature on autonomy and decision-making capacity by focusing on the case of individuals with opioid use disorder who refuse to remain in the hosp...

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...

Volume 20, Issue 8, August 2020, Page 88-90.

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)

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

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...

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)

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)

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...

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)

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...

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)

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)

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)

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.

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.

BackgroundThe proper and ethical inclusion of PWLHIV and their young children in research is paramount to ensure valid evidence is generated to optimize treatment and care. Little empirical data exists to inform ethical considerations deemed most critical to these populations. Our study aimed to systematically review the empiric literature regarding ethical considerations for research participation of PWLHIV and their young children.MethodsWe conducted this systematic review in partnership with a medical librarian. A search strategy was designed and performed within the following (...) electronic databases: Ovid MEDLINE, Embase and CINAHL. We screened titles and abstracts using the following inclusion criteria: (1) a study population of PWLHIV or children under 5 years of age; and (2) collection of qualitative or quantitative data regarding ethics of research participation. Excluded were reviews, commentaries, policy statements, clinical care-related ethics concerns, abstracts, case studies, or studies unrelated to HIV research. Studies were appraised for quality, data were extracted, and studies were qualitatively analyzed using a principle-based ethical framework within the Belmont Report.ResultsOf the 7470 titles identified, 538 full-text articles were reviewed for eligibility and only three articles met full criteria for inclusion within this review. While we allowed for inclusion of studies involving young children born to mothers with HIV, only articles focused on PWLHIV were identified. Within the results of these studies, four themes emerged: (1) adequacy of informed consent; (2) consideration of paternal involvement; (3) balancing risks; and (4) access to research and treatment. A strength of this review is that it included perspectives of international research investigators, community leaders, and male partners. However, only two studies collected empiric data from PWLHIV regarding their experiences participating in researchConclusionResearchers and funding agencies should be aware of these considerations and appreciate the value of and critical need for formative research to ensure clinical trials involving PWLHIV promote ethical, well-informed research participation and, ultimately, improve care outcomes. More research is needed to create a comprehensive ethical framework for researchers when conducting studies with PWLHIV. (shrink)

The Lion King is a Disney version of Shakespeare's most famous play, Hamlet. It was going to be the first Disney animated feature film based on an original concept – no source material. Hamlet's famous “to be or not to be” soliloquy rings with existential absurdity, and his morbid brooding reflects a sense of meaninglessness. The existential question of being permeates both play and film. The Lion King transfers Hamlet's contemplative question about life and death to not one but two (...) delightful characters, perfect for manufacture and distribution as stuffed animals, plastic action figures, plates, cups, stickers, one names it. After he leaves the Pride Lands, Simba runs into Timon the meerkat and Pumbaa the warthog who offer him an answer to Hamlet's question. The Lion King ends with song and the celebration of Simba's own son – the circle of life continues. (shrink)

Molly is just a unique little girl who likes what she likes. But if she were concerned about the way Disney portrays women, she would do well to consider The Little Mermaid. Ariel represents a major step forward from Snow White. Ariel's treasure trove is full of dinglehoppers and snarfblats, but once she lays eyes on Prince Eric, the young man is the prize she wants most. When the Prince's ship splits, The Little Mermaid flips the script. For all her (...) shortcomings from a feminist perspective, unruly Ariel represents a move in the right direction. The Little Mermaid does not belong in the hall of shame, like Song of the South. Adolescent Ariel sings and leads a viewing public into a new, fresh take on Disney princesses, with a voice reminding everyone to be assertive, speak their minds, and do what they want to do. (shrink)

Two reports have shown that mammalian artificial chromosomes (MAC) can be constructed from cloned human centromere DNA and telomere repeats, proving the principle that chromosomes can form from naked DNA molecules transfected into human cells. The MACs were mitotically stable, low copy number and bound antibodies associated with active centromeres. As a step toward second-generation MACs, yeast and bacterial cloning systems will have to be adapted to achieve large MAC constructs having a centromere, two telomeres, and genomic copies of mammalian (...) genes. Available construction techniques are discussed along with a new P1 artificial chromosome (PAC)-derived telomere vector (pTAT) that can be joined to other PACs in vitro, avoiding a cloning step during which large repetitive arrays often rearrange. The PAC system can be used as a route to further define the optimal DNA elements required for efficient MAC formation, to investigate the expression of genes on MACs, and possibly to develop efficient MAC-delivery protocols. BioEssays 1999;21:76–83. © 1999 John Wiley & Sons, Inc. (shrink)

This book addresses the idea of justice in order to guide society towards a more effective justice system. The authors trace impoverished and accomplished thinking in criminological and justice discourses and show that when justice and love are seen as synonyms, the historic ills that have plagued humanity tend to evaporate.

BackgroundCommunity engagement within biomedical research is broadly defined as a collaborative relationship between a research team and a group of individuals targeted for research. A Community Advisory Board is one mechanism of engaging the community. Within genomics research CABs may be particularly relevant due to the potential implications of research findings drawn from individual participants on the larger communities they represent. Within such research, CABs seek to meet instrumental goals such as protecting research participants and their community from research-related risks, (...) as well as intrinsic goals such as promoting the respect of participants and their community. However, successful community engagement depends on the degree to which CABs legitimately represent and engage with communities targeted for research. Currently, there is little literature describing the use of CABs in genomics research taking place in developing countries, and even less in the field of genomics research relating to mental illness. The aim of this article is to describe and consider the contributions made by a researcher-driven, population-specific CAB in a genomics of schizophrenia research project taking place in South Africa, from the perspective of the research team.DiscussionFour broad discussion topics emerged during the CAB meetings namely: 1) informed consent procedures, 2) recruitment strategies, 3) patient illness beliefs and stigma experiences, and 4) specific ethical concerns relating to the project. The authors consider these discussions in terms of their contributions to instrumental and intrinsic goals of community engagement.SummaryThe CAB gave valuable input on the consent processes and materials, recruitment strategies and suggested ways of minimizing the potential for stigma and discrimination. All of these contributions were of an instrumental nature, and helped improve the way in which the research took place. In addition, and perhaps more importantly, the CAB made a unique and important contribution relating to intrinsic functions such as promoting the respect and dignity of research participants and their community. This was particularly evident in ensuring sensitivity and respect of the community’s traditional beliefs about schizophrenia and its treatment, and in this way promoting a respectful relationship between the research team and the participants. (shrink)

As next‐generation genomic sequencing, including whole‐genome sequencing information, becomes more common in research, clinical, and public health contexts, there is a need for comprehensive communication strategies and education approaches to prepare patients and clinicians to manage this information and make informed decisions about its use, and nowhere is that imperative more pronounced than when genomic sequencing is applied to newborns. Unfortunately, in‐person counseling is unlikely to be applicable or cost‐effective when parents obtain genomic risk information directly via the Internet. As (...) a rule, communication strategies should match how people are accessing health information. Today, many people can obtain health information in a variety of settings, including through direct‐to‐consumer services, via websites, and through other digital channels or settings. In response to these changes, new communication strategies need to be considered. Adopting a comprehensive communication model means understanding the multiple levels of influence experienced by parents and the clinicians who serve them. In addition, applying communication‐science principles can help in addressing some key challenges to effectively communicating genomic information to parents. (shrink)

Ethics courses are most commonly evaluated using reaction measures. However, little is known about the specific types of reaction data being collected and how these reaction data relate to improvements in trainee performance. Using a sample of 381 ethics training sessions, major reaction data categories were identified. Content and course satisfaction were the most frequently collected types of reaction criteria. Furthermore, content relevance and course satisfaction showed strong, positive relationships with performance criteria, whereas content satisfaction demonstrated a moderate, negative relationship. (...) These results and future directions for ethics training evaluation are discussed. (shrink)

Here, Bob Hale and Crispin Wright assemble the key writings that lead to their distinctive neo-Fregean approach to the philosophy of mathematics. In addition to fourteen previously published papers, the volume features a new paper on the Julius Caesar problem; a substantial new introduction mapping out the program and the contributions made to it by the various papers; a section explaining which issues most require further attention; and bibliographies of references and further useful sources. It will be recognized as (...) the most powerful presentation yet of a neo-Fregean program. (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.

The underdetermination thesis poses a threat to rational choice of scientific theories. We discuss two arguments for the thesis. One draws its strength from deductivism together with the existence thesis, and the other is defended on the basis of the failure of a reliable inductive method. We adopt a partially subjective/objective pragmatic Bayesian epistemology of science framework, and reject both arguments for the thesis. Thus, in science we are able to reinstate rational choice called into question by the underdetermination thesis.

For much of their history, the relationship between anthropology and psychology has been well captured by Robert Frost's poem, “Mending Wall,” which ends with the ironic line, “good fences make good neighbors.” The congenial fence was that anthropology studied what people think and psychology studied how people think. Recent research, however, shows that content and process cannot be neatly segregated, because cultural differences in what people think affect how people think. To achieve a deeper understanding of the relation between process (...) and content, research must integrate the methodological insights from both anthropology and psychology. We review previous research and describe new studies in the domain of folk biology which examine the cognitive consequences of different conceptualizations of nature and the place of humans within it. The focus is on cultural differences in framework theories among Native Americans and European American children and adults living in close proximity in rural Wisconsin. Our results show that epistemological orientations affect memory organization, ecological reasoning, and the perceived role of humans in nature. This research also demonstrates that cultural differences in framework theories have implications for understanding intergroup conflict over natural resources and are relevant to efforts to improve science learning, especially among Native American children. (shrink)

This article systematically reviews studies investigating the effect of three operationalizations of complexity in emotion experience on situat...