Brain Pioneers and Moral Entanglement: An Argument for Post-trial Responsibilities in Neural-Device Trials.

We argue that in implanted neurotechnology research, participants and researchers experience what Henry Richardson has called "moral entanglement." Participants partially entrust researchers with access to their brains and thus to information that would otherwise be private, leading to created intimacies and special obligations of beneficence for researchers and research funding agencies. One of these obligations, we argue, is about continued access to beneficial technology once a trial ends. We make the case for moral entanglement in this context through exploration of participants' vulnerability, uncompensated risks and burdens, depth of relationship with the research team, and dependence on researchers in implanted neurotechnology trials.

Cognitive Enhancement as Transformative Experience: The Challenge of Wrapping One's Mind Around Enhanced Cognition via Neurostimulation.

In this paper, the authors explore the question of whether cognitive enhancement via direct neurostimulation, such as through deep brain stimulation, could be reasonably characterized as a form of transformative experience. This question is inspired by a qualitative study being conducted with people at risk of developing dementia and in intimate relationships with people living with dementia (PLWD). They apply L.A. Paul's work on transformative experience to the question of cognitive enhancement and explore potential limitations on the kind of claims that can legitimately be made about individual well-being and flourishing, as well as limit the kind of empirical work-including the authors' own-that can hope to enlighten ethical discourse. In this paper, the authors advance the following theses: (1) it is sometimes reasonable to characterize cognitive enhancement as a transformative experience; (2) the testimonies of people intimately acquainted with dementia may still be relevant to evaluating cognitive enhancement even though cognitive enhancement may be a transformative experience; and (3) qualitative studies may still be useful in the ethical analysis of cognitive enhancement, but special attention may need to be given to how these are conducted and what kind of insights can be drawn from them.

Can I Hold That Thought for You? Dementia and Shared Relational Agency.

Agency is talked about by many as something that people living with dementia lose, once they've lost much else-autonomy, identity, and privacy, among other things. While the language of loss may capture some of what transpires in dementia, it can obscure how people living with dementia and their loved ones share agency through sharing capacities for memory, language, and decision-making. We suggest that one consequence of adopting a framework of loss is that it makes the default response to changes in agency the substitution of a family member's agency for the purported lost agency of someone living with dementia. We argue for an alternative framework in which sharing agency is recognized as a central feature of living with dementia. Building on the work of relational theorists, we argue for the value of thinking about agency in dementia as fundamentally shared, and explore potential implications for treatment, caregiver support, and building dementia-friendly environments.

Deep Brain Stimulation for Substance Use Disorders? An Exploratory Qualitative Study of Perspectives of People Currently in Treatment.

OBJECTIVE: Although previous studies have discussed the promise of deep brain stimulation (DBS) as a possible treatment for substance use disorders (SUDs) and collected researcher perspectives on possible ethical issues surrounding it, none have consulted people with SUDs themselves. We addressed this gap by interviewing people with SUDs. METHODS: Participants viewed a short video introducing DBS, followed by a 1.5-hour semistructured interview on their experiences with SUDs and their perspective on DBS as a possible treatment option. Interviews were analyzed by multiple coders who iteratively identified salient themes. RESULTS: We interviewed 20 people in 12-step-based, inpatient treatment programs (10 [50%] White/Caucasian, 7 Black/African American [35%], 2 Asian [10%], 1 Hispanic/Latino [5%], and 1 [5%] Alaska Native/American Indian; 9 women [45%], 11 men [55%]). Interviewees described a variety of barriers they currently faced through the course of their disease that mirrored barriers often associated with DBS (stigma, invasiveness, maintenance burdens, privacy risks) and thus made them more open to the possibility of DBS as a future treatment option. CONCLUSIONS: Individuals with SUDs gave relatively less weight to surgical risks and clinical burdens associated with DBS than previous surveys of provider attitudes anticipated. These differences derived largely from their experiences living with an often-fatal disease and encountering limitations of current treatment options. These findings support the study of DBS as a treatment option for SUDs, with extensive input from people with SUDs and advocates.

What does it mean to call a medical device invasive?

Medical devices are often referred to as being invasive or non-invasive. Though invasiveness is relevant, and central, to how devices are understood and regarded in medicine and bioethics, a consensus concept or definition of invasiveness is lacking. To begin to address this problem, this essay explores four possible descriptive meanings of invasiveness: how devices are introduced to the body, where they are located in the body, whether they are foreign to the body, and how they change the body. An argument is offered that invasiveness is not purely descriptive, but implicates normative concepts of danger, intrusion, and disruption. In light of this, a proposal is offered for how to understand use of the concept of invasiveness in discussions of medical devices.

The Role of Family Members in Psychiatric Deep Brain Stimulation Trials: More Than Psychosocial Support.

Family members can provide crucial support to individuals participating in clinical trials. In research on the "newest frontier" of Deep Brain Stimulation (DBS)-the use of DBS for psychiatric conditions-family member support is frequently listed as a criterion for trial enrollment. Despite the significance of family members, qualitative ethics research on DBS for psychiatric conditions has focused almost exclusively on the perspectives and experiences of DBS recipients. This qualitative study is one of the first to include both DBS recipients and their family members as interview participants. Using dyadic thematic analysis-an approach that takes both the individuals and the relationship as units of analyses-this study analyzes the complex ways in which family relationships can affect DBS trial participation, and how DBS trial participation in turn influences family relationships. Based on these findings, we propose ways to improve study designs to better take family relationships into account, and better support family members in taking on the complex, essential roles that they play in DBS trials for psychiatric conditions. Supplementary Information: The online version contains supplementary material available at 10.1007/s12152-023-09520-7.

Towards clinical application of implantable brain-computer interfaces for people with late-stage ALS: medical and ethical considerations.

Individuals with amyotrophic lateral sclerosis (ALS) frequently develop speech and communication problems in the course of their disease. Currently available augmentative and alternative communication technologies do not present a solution for many people with advanced ALS, because these devices depend on residual and reliable motor activity. Brain-computer interfaces (BCIs) use neural signals for computer control and may allow people with late-stage ALS to communicate even when conventional technology falls short. Recent years have witnessed fast progression in the development and validation of implanted BCIs, which place neural signal recording electrodes in or on the cortex. Eventual widespread clinical application of implanted BCIs as an assistive communication technology for people with ALS will have significant consequences for their daily life, as well as for the clinical management of the disease, among others because of the potential interaction between the BCI and other procedures people with ALS undergo, such as tracheostomy. This article aims to facilitate responsible real-world implementation of implanted BCIs. We review the state of the art of research on implanted BCIs for communication, as well as the medical and ethical implications of the clinical application of this technology. We conclude that the contribution of all BCI stakeholders, including clinicians of the various ALS-related disciplines, will be needed to develop procedures for, and shape the process of, the responsible clinical application of implanted BCIs.

Ethical issues raised by incorporating personalized language models into brain-computer interface communication technologies: a qualitative study of individuals with neurological disease.

PURPOSE: To examine the views of individuals with neurodegenerative diseases about ethical issues related to incorporating personalized language models into brain-computer interface (BCI) communication technologies. METHODS: Fifteen semi-structured interviews and 51 online free response surveys were completed with individuals diagnosed with neurodegenerative disease that could lead to loss of speech and motor skills. Each participant responded to questions after six hypothetical ethics vignettes were presented that address the possibility of building language models with personal words and phrases in BCI communication technologies. Data were analyzed with consensus coding, using modified grounded theory. RESULTS: Four themes were identified. (1) The experience of a neurodegenerative disease shapes preferences for personalized language models. (2) An individual's identity will be affected by the ability to personalize the language model. (3) The motivation for personalization is tied to how relationships can be helped or harmed. (4) Privacy is important to people who may need BCI communication technologies. Responses suggest that the inclusion of personal lexica raises ethical issues. Stakeholders want their values to be considered during development of BCI communication technologies. CONCLUSIONS: With the rapid development of BCI communication technologies, it is critical to incorporate feedback from individuals regarding their ethical concerns about the storage and use of personalized language models. Stakeholder values and preferences about disability, privacy, identity and relationships should drive design, innovation and implementation.IMPLICATIONS FOR REHABILITATIONIndividuals with neurodegenerative diseases are important stakeholders to consider in development of natural language processing within brain-computer interface (BCI) communication technologies.The incorporation of personalized language models raises issues related to disability, identity, relationships, and privacy.People who may one day rely on BCI communication technologies care not just about usability of communication technology but about technology that supports their values and priorities.Qualitative ethics-focused research is a valuable tool for exploring stakeholder perspectives on new capabilities of BCI communication technologies, such as the storage and use of personalized language models.

Asking questions that matter - Question prompt lists as tools for improving the consent process for neurotechnology clinical trials.

Implantable neurotechnology devices such as Brain Computer Interfaces (BCIs) and Deep Brain Stimulators (DBS) are an increasing part of treating or exploring potential treatments for neurological and psychiatric disorders. While only a few devices are approved, many promising prospects for future devices are under investigation. The decision to participate in a clinical trial can be challenging, given a variety of risks to be taken into consideration. During the consent process, prospective participants might lack the language to consider those risks, feel unprepared, or simply not know what questions to ask. One tool to help empower participants to play a more active role during the consent process is a Question Prompt List (QPL). QPLs are communication tools that can prompt participants and patients to articulate potential concerns. They offer a structured list of disease, treatment, or research intervention-specific questions that research participants can use as support for question asking. While QPLs have been studied as tools for improving the consent process during cancer treatment, in this paper, we suggest they would be helpful in neurotechnology research, and offer an example of a QPL as a template for an informed consent tool in neurotechnology device trials.

Relational autonomy and the clinical relationship in dementia care.

The clinical relationship (or doctor-patient relationship) has been underexplored in dementia care. This is in part due to the way that the clinical relationship has been articulated and understood in bioethics. Robert Veatch's social contract model is representative of a standard view of the clinical relationship in bioethics. But dementia presents formidable challenges to the standard clinical relationship, including ambiguity about when the clinical relationship begins, how it weathers changes in narrative identity of patients with dementia, and how the intimate involvement of family fits alongside a paradigmatically dyadic relationship. Drawing on work in recent feminist theory, a critique is offered of the standard clinical relationship in bioethics as underwritten by an individualistic conception of autonomy. An alternative view of the clinical relationship in dementia, one that embraces a relational account of autonomy, is put forward.

"Re-identifying yourself": a qualitative study of veteran views on implantable BCI for mobility and communication in ALS.

OBJECTIVES: Brain-computer interface (BCI) technology to assist with mobility and communication is an active area of research in amyotrophic lateral sclerosis (ALS). Implantable BCI offers promise for individuals with severe disease, such as locked-in syndrome, but also raises important ethical issues. We undertook in-depth qualitative interviews with ALS patients from a Veterans Administration hospital ALS multi-disciplinary clinic and explored their perspectives on issues of identity, privacy, enhancement, informed consent, and responsibility related to implantable BCI. METHODS: Semi-structured interviews were conducted with sixteen (n = 16) individuals, and transcripts were analysed using a modified grounded theory approach. RESULTS: Emergent themes included: (1) attitudes towards BCI were characterised by fear, hope, and hesitation about adoption of BCI technology; (2) analogies to other technologies were a useful tool in understanding and communicating opinions about ethical issues in BCI; (3) concerns about potentially socially stigmatising effects of BCI and the burden of adjustment to new therapeutic devices were important considerations to be weighed against the potential functional benefit of BCI use; (4) therapeutic decision-making in ALS often intimately involves loved ones; and (5) prospective decision-making about BCI was significantly affected by weighing the timing of the intervention with the progression of illness. CONCLUSION: The interest in BCI and views on ethical issues raised by BCI is moderated by the experience of living with ALS. The findings from this study can help guide the development of implantable BCI technology for persons with ALS.Implications for rehabilitationLoved ones will play crucial roles in helping patients think through the possible benefits and burdens of getting a BCI device.Providers should consider how the ideal timing for getting an implantable BCI device will vary based on the priorities of persons with ALS and their disease stage.Concerns about social stigma, burden of adjustment, and the desire to maximise time left with loved ones may outweigh the potential functional benefits of BCI devices for some persons with ALS.

Neuroethics Inside and Out: A Comparative Survey of Neural Device Industry Representatives and the General Public on Ethical Issues and Principles in Neurotechnology.

Neurotechnologies are rapidly being developed with the aim of alleviating suffering caused by disease and assisting individuals with various disabilities. As the capabilities and applications of neural devices advance, potential ethical challenges related to agency, identity, privacy, equality, normality and justice have been noted. We sought to explore attitudes toward these ethical challenges in two important, but understudied groups of stakeholders-members of the neural device industry and members of the general public. Survey responses from 66 industry professionals and 1088 members of the general public who do not work with neural devices were collected. After controlling for demographic differences between the groups (industry vs. general public; age, gender, racial/ethnic background), we found a large degree of consistency between the groups in their attitudes toward the ethical topic areas and the need for guiding ethical principles, but also some differences related to privacy, consent, and confidence in the neural device industry to incorporate ethical concerns into the design process. These data have implications for industry professionals tasked with designing and disseminating new neural devices, end-users of their products, and stakeholders at each step in between who must navigate the rapidly-growing landscape of advances in neurotechnology.

Ethical Issues in Intraoperative Neuroscience Research: Assessing Subjects' Recall of Informed Consent and Motivations for Participation.

BackgroundAn increasing number of studies utilize intracranial electrophysiology in human subjects to advance basic neuroscience knowledge. However, the use of neurosurgical patients as human research subjects raises important ethical considerations, particularly regarding informed consent and undue influence, as well as subjects' motivations for participation. Yet a thorough empirical examination of these issues in a participant population has been lacking. The present study therefore aimed to empirically investigate ethical concerns regarding informed consent and voluntariness in Parkinson's disease patients undergoing deep brain stimulator (DBS) placement who participated in an intraoperative neuroscience study.MethodsTwo semi-structured 30-minute interviews were conducted preoperatively and postoperatively via telephone. Interviews assessed participants' motivations for participation in the parent intraoperative study, recall of information presented during the informed consent process, and participants' postoperative reflections on the research study.ResultsTwenty-two participants (mean age = 60.9) completed preoperative interviews at a mean of 7.8 days following informed consent and a mean of 5.2 days prior to DBS surgery. Twenty participants completed postoperative interviews at a mean of 5 weeks following surgery. All participants cited altruism or advancing medical science as "very important" or "important" in their decision to participate in the study. Only 22.7% (n = 5) correctly recalled one of the two risks of the study. Correct recall of other aspects of the informed consent was poor (36.4% for study purpose; 50.0% for study protocol; 36.4% for study benefits). All correctly understood that the study would not confer a direct therapeutic benefit to them.ConclusionEven though research coordinators were properly trained and the informed consent was administered according to protocol, participants demonstrated poor retention of study information. While intraoperative studies that aim to advance neuroscience knowledge represent a unique opportunity to gain fundamental scientific knowledge, improved standards for the informed consent process can help facilitate their ethical implementation.

Trading Vulnerabilities: Living with Parkinson's Disease before and after Deep Brain Stimulation.

Implanted medical devices-for example, cardiac defibrillators, deep brain stimulators, and insulin pumps-offer users the possibility of regaining some control over an increasingly unruly body, the opportunity to become part "cyborg" in service of addressing pressing health needs. We recognize the value and effectiveness of such devices, but call attention to what may be less clear to potential users-that their vulnerabilities may not entirely disappear but instead shift. We explore the kinds of shifting vulnerabilities experienced by people with Parkinson's disease (PD) who receive therapeutic deep brain stimulators to help control their tremors and other symptoms of PD.