Neural devices have the capacity to enable users to regain abilities lost due to disease or injury – for instance, a deep brain stimulator (DBS) that allows a person with Parkinson’s disease to regain the ability to fluently perform movements or a Brain Computer Interface (BCI) that enables a person with spinal cord injury to control a robotic arm. While users recognize and appreciate the technologies’ capacity to maintain or restore their capabilities, the neuroethics literature is replete with examples of (...) concerns expressed about agentive capacities: A perceived lack of control over the movement of a robotic arm might result in an altered sense of feeling responsible for that movement. Clinicians or researchers being able to record and access detailed information of a person’s brain might raise privacy concerns. A disconnect between previous, current, and future understandings of the self might result in a sense of alienation. The ability to receive and interpret sensory feedback might change whether someone trusts the implanted device or themselves. Inquiries into the nature of these concerns and how to mitigate them has produced scholarship that often emphasizes one issue – responsibility, privacy, authenticity, or trust – selectively. However, we believe that examining these ethical dimensions separately fails to capture a key aspect of the experience of living with a neural device. In exploring their interrelations, we argue that their mutual significance for neuroethical research can be adequately captured if they are described under a unified heading of agency. On these grounds, we propose an “Agency Map” which brings together the diverse neuroethical dimensions and their interrelations into a comprehensive framework. With this, we offer a theoretically-grounded approach to understanding how these various dimensions are interwoven in an individual’s experience of agency. (shrink)

Advancements in novel neurotechnologies, such as brain computer interfaces and neuromodulatory devices such as deep brain stimulators, will have profound implications for society and human rights. While these technologies are improving the diagnosis and treatment of mental and neurological diseases, they can also alter individual agency and estrange those using neurotechnologies from their sense of self, challenging basic notions of what it means to be human. As an international coalition of interdisciplinary scholars and practitioners, we examine these challenges and make (...) recommendations to mitigate negative consequences that could arise from the unregulated development or application of novel neurotechnologies. We explore potential ethical challenges in four key areas: identity and agency, privacy, bias, and enhancement. To address them, we propose democratic and inclusive summits to establish globally-coordinated ethical and societal guidelines for neurotechnology development and application, new measures, including “Neurorights,” for data privacy, security, and consent to empower neurotechnology users’ control over their data, new methods of identifying and preventing bias, and the adoption of public guidelines for safe and equitable distribution of neurotechnological devices. (shrink)

Neural engineering technologies such as implanted deep brain stimulators and brain-computer interfaces represent exciting and potentially transformative tools for improving human health and well-being. Yet their current use and future prospects raise a variety of ethical and philosophical concerns. Devices that alter brain function invite us to think deeply about a range of ethical concerns—identity, normality, authority, responsibility, privacy, and justice. If a device is stimulating my brain while I decide upon an action, am I still the author of the (...) action? Does a device make the interiority of my experience accessible to others? Will the device change the way I think of myself and others think of me? Such fundamental questions arise even when a device is designed for only a relatively circumscribed purpose, such as restoring functioning via a smart prosthetic. We are part of a National Science Foundation-funded Engineering Research Center tasked with investigating philosophical and social implications of neural engineering research and technologies. Neural devices already in clinical use, such as deep brain stimulators for Parkinson's disease or essential tremor, have spurred healthy debate about such implications. Devices currently under development—such as the BrainGate System of implanted brain sensors coupled to robotics in persons with paralysis, exoskeletons for augmented movement, transcranial do-it-yourself stimulators, closed-loop brain stimulating systems, or even brain-to-brain interfacing—promise to extend and deepen these debates. At our center, brain-computer interfaces are the principal focus of work. Even acknowledging that the clinical translation of neural devices and seamless integration by end users may still largely reside in the future, the potential these devices hold calls for careful early analysis. The launching of the Brain Research through Advancing Innovative Neurotechnologies Initiative in April 2013 provides further impetus for this work. (shrink)

Implantable brain–computer interface technology is an expanding area of engineering research now moving into clinical application. Ensuring meaningful informed consent in implantable BCI research is an ethical imperative. The emerging and rapidly evolving nature of implantable BCI research makes identification of risks, a critical component of informed consent, a challenge. In this paper, 6 core risk domains relevant to implantable BCI research are identified—short and long term safety, cognitive and communicative impairment, inappropriate expectations, involuntariness, affective impairment, and privacy and security. (...) Work in deep brain stimulation provides a useful starting point for understanding this core set of risks in implantable BCI. Three further risk domains—risks pertaining to identity, agency, and stigma—are identified. These risks are not typically part of formalized consent processes. It is important as informed consent practices are further developed for implantable BCI research that attention be paid not just to disclosing core research risks but exploring the meaning of BCI research with potential participants. (shrink)

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. (shrink)

Brain–Computer Interface research is an interdisciplinary area of study within Neural Engineering. Recent interest in end-user perspectives has led to an intersection with user-centered design. The goal of user-centered design is to reduce the translational gap between researchers and potential end users. However, while qualitative studies have been conducted with end users of BCI technology, little is known about individual BCI researchers’ experience with and attitudes towards UCD. Given the scientific, financial, and ethical imperatives of UCD, we sought to gain (...) a better understanding of practical and principled considerations for researchers who engage with end users. We conducted a qualitative interview case study with neural engineering researchers at a center dedicated to the creation of BCIs. Our analysis generated five themes common across interviews. The thematic analysis shows that participants identify multiple beneficiaries of their work, including other researchers, clinicians working with devices, device end users, and families and caregivers of device users. Participants value experience with device end users, and personal experience is the most meaningful type of interaction. They welcome end-user input, but are skeptical of limited focus groups and case studies. They also recognize a tension between creating sophisticated devices and developing technology that will meet user needs. Finally, interviewees espouse functional, assistive goals for their technology, but describe uncertainty in what degree of function is “good enough” for individual end users. Based on these results, we offer preliminary recommendations for conducting future UCD studies in BCI and neural engineering. (shrink)

Patients with amyotrophic lateral sclerosis face many difficult, timing-sensitive decisions over the course of their illness, weighing present versus future harms and benefits. Supplemented by interviews with people with ALS, we argue for a relational approach to understanding these decisions and their effects on identity. We highlight two critical aspects of the patient–caregiver relationship: the extent to which each may rely on the other leaves their wellbeing intimately intertwined and patients often require others to help with the imaginative task of (...) considering possible futures for each therapeutic option. We show why family involvement in decisionmaking practices can be so critical, and shed light on the ways intimate others help preserve and protect people’s identities amidst the destabilizing uncertainty illness and treatment can bring. (shrink)

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. (shrink)

The clinical 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. (shrink)

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. (shrink)

Separation-based accounts of privacy define privacy as being left alone and unaccessed. Pyrrho et al. propose a more control-based account where privacy is about having the age...

Invasive neurotechnologies are a frequent subject of discussion in neuroethics. Technologies, like deep brain stimulation and implantable brain-computer interfaces, are thought to hold significant promise for human health and well-being, but they also raise important ethical questions about autonomy, safety, stigma, privacy, and agency, among others. The terms ‘invasive’ and ‘invasiveness’ are commonly applied to these and other neurotechnologies, yet the concept of invasiveness itself is rarely defined or delimited. Some have suggested that invasiveness may have multiple meanings – physical, (...) emotional, or lifestyle – and that confusion about how people use the terms may lead to harm, especially for users of invasive devices. It is uncertain if debates in neuroethics contribute to this confusion. To investigate this, we conducted a study of how the term ‘invasiveness’ is used in neuroethics. We found that neuroethicists almost always use ‘invasiveness’ to refer to the physical features of interventions, and rarely to refer to other senses of invasiveness. We also found that referencing invasiveness does not determine which ethical issues are prioritized for a given type of neurotechnology. Overall, this study affirms the importance of understanding the meaning and use of the concept of invasiveness in ethical discussion of neurotechnology while also suggesting the need for further work in the area and consideration for rethinking what forms of technology we consider to be invasive. (shrink)

Clinical neuroethics and neuroskepticism are recent entrants to the vocabulary of neuroethics. Clinical neuroethics has been used to distinguish problems of clinical relevance arising from developments in brain science from problems arising in neuroscience research proper. Neuroskepticism has been proposed as a counterweight to claims about the value and likely implications of developments in neuroscience. These two emergent streams of thought intersect within the practice of neurology. Neurologists face many traditional problems in bioethics, like end of life care in the (...) persistent vegetative state, determination of capacity in progressive dementia, and requests for assisted suicide in cognition-preserving neurodegenerative disease (like amyotrophic lateral sclerosis). Neurologists also look to be at the forefront of downstream clinical applications of neuroscience, like pharmacological enhancement of mental life. At the same time, the practice of neurology, concerned primarily with the structure, function, and treatment of the nervous system, has historically fostered a kind of skeptical attitude toward its own subject matter. Not all problems that appear primarily neurological are primarily neurological. This disciplinary skepticism is generally clinical in orientation and limited in scope. The rise of interest in clinical neuroethics and in neuroskepticsim generally suggests a possible broader application. The clinical skepticism of neurology provides impetus for thinking about the appropriate role for skepticism in clinical areas of neuroethics. After a brief review of neuroskepticism and clinical neuroethics, a taxonomy of clinical neuroskepticism is offered and reasons why a stronger rather than weaker form of clinical neuroskepticism is currently warranted. (shrink)

Neural engineers and clinicians are starting to translate advances in electrodes, neural computation, and signal processing into clinically useful devices to allow control of wheelchairs, spellers, prostheses, and other devices. In the process, large amounts of brain data are being generated from participants, including intracortical, subdural and extracranial sources. Brain data is a vital resource for BCI research but there are concerns about whether the collection and use of this data generates risk to privacy. Further, the nature of BCI research (...) involves understanding and making inferences about device users’ mental states, thoughts, and intentions. This, too, raises privacy concerns by providing otherwise unavailable direct or privileged access to individuals mental lives. And BCI-controlled prostheses may change the way clinical care is provided and the type of physical access caregivers have to patients. This, too, has important privacy implications. I In this chapter we examine several of these privacy concerns in light of prominent views of the nature and value of privacy. We argue that increased scrutiny needs to be paid to privacy concerns arising from Big Data and decoding of mental states, but that BCI research may also provide opportunity for individuals to enhance their privacy. (shrink)

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. (shrink)

Brain-computer Interface (BCI) research is rapidly expanding, and it engages domains of human experience that many find central to our current understanding of ourselves. Ethical principles or guidelines can provide researchers with tools to engage in ethical reflection and to address practical problems in research. Though researchers have called for clearer ethical principles or guidelines, there is little existing data on what form these should take. We developed a prospective set of ethical principles for BCI research with specific guidelines and (...) shared them, via a survey, to participants at the 6th International BCI Meeting at the Asilomar Conference Center in 2016. Respondents were broadly supportive of principles of Care for Subjects, Modesty, Participation, Inclusivity, Relationality, Justice, and Social Impact. Principles more traditionally aligned with responsible conduct of research showed higher levels of endorsement. Researcher support for specific principle-based ethical guidelines varied with respect to stringency of researcher obligations. (shrink)

Recent advancements in neuroengineering research have prompted neuroethicists to propose a variety of “ethical guidance” frameworks (e.g., principles, guidelines, framing questions, responsible research innovation frameworks, and ethical priorities) to inform this work. In this chapter, we offer a comparative analysis of five recently proposed ethical guidance frameworks (NIH neuroethics guiding principles, Nuffield Council on Bioethics, Global Neuroethics Summit Delegates, the Center for Neurotechnology’s neuroethical principles and guidelines, and the Neurotechnology Ethics Taskforce’s ethical priorities). We identify some common themes among these (...) frameworks, making explicit significant areas of convergence. We also highlight three areas of ethical consideration that have not received sufficient attention across these frameworks (extended care for research participants, cultural salience, and stakeholder input). Further attention and analysis of these three areas would improve the breadth and scope of ethical considerations for neuroengineering research. (shrink)

Implantable neurotechnology devices such as Brain Computer Interfaces and Deep Brain Stimulators 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. 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. (shrink)

Devices that record from and stimulate the brain are currently available for consumer use. The increasing sophistication and resolution of these devices provide consumers with the opportunity to engage in do-it-yourself brain research and contribute to neuroscience knowledge. The rise of do-it-yourself (DIY) neuroscience may provide an enriched fund of neural data for researchers, but also raises difficult questions about data quality, standards, and the boundaries of scientific practice. We administered an online survey to brain–computer interface (BCI) researchers to gather (...) their perspectives on DIY brain research. While BCI researcher concerns about data quality and reproducibility were high, the possibility of expert validation of data generated by citizen neuroscientists mitigated concerns. We discuss survey results in the context of an established ethical framework for citizen science, and describe the potential of constructive collaboration between citizens and researchers to both increase data collection and advance understanding of how the brain operates outside the confines of the lab. (shrink)

The American Journal of Bioethics, Volume 12, Issue 2, Page 26-27, February 2012.

As members of a neuroethics research group funded by the NIH, we echo the call from Fabi and Goldberg for greater funding parity between the ethics of specialized medical technologies and br...