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)

Connecting human minds to various technological devices and applications through brain-computer interfaces (BCIs) affords intriguingly novel ways for humans to engage and interact with the world. Not only do BCIs play an important role in restorative medicine, they are also increasingly used outside of medical or therapeutic contexts (e.g., gaming or mental state monitoring). A striking peculiarity of BCI technology is that the kind of actions it enables seems to differ from paradigmatic human actions, because, effects in the world are (...) brought about by devices such as robotic arms, prosthesis, or other machines, and their execution runs through a computer directed by brain signals. In contrast to usual forms of action, the sequence does not need to involve bodily or muscle movements at all. A motionless body, the epitome of inaction, might be acting. How do theories of action relate to such BCI-mediated forms of changing the world? We wish to explore this question through the lenses of three perspectives on agency: subjective experience of agency, philosophical action theory, and legal concepts of action. Our analysis pursues three aims: First, we shall discuss whether and which BCI-mediated events qualify as actions, according to the main concepts of action in philosophy and law. Secondly, en passant, we wish to highlight the ten most interesting novelties or peculiarities of BCI-mediated movements. Thirdly, we seek to explore whether these novel forms of movement may have consequences for concepts of agency. More concretely, we think that convincing assessments of BCI-movements require more fine-grained accounts of agency and a distinction between various forms of control during movements. In addition, we show that the disembodied nature of BCI-mediated events causes troubles for the standard legal account of actions as bodily movements. In an exchange with views from philosophy, we wish to propose that the law ought to reform its concept of action to include some, but not all, BCI-mediated events and sketch some of the wider implications this may have, especially for the venerable legal idea of the right to freedom of thought. In this regard, BCIs are an example of the way in which technological access to yet largely sealed-off domains of the person may necessitate adjusting normative boundaries between the personal and the social sphere. (shrink)

Deep brain stimulation has been of considerable interest to bioethicists, in large part because of the effects that the intervention can occasionally have on central features of the recipient’s personality. These effects raise questions regarding the philosophical concept of authenticity. In this article, we expand on our earlier work on the concept of authenticity in the context of deep brain stimulation by developing a diachronic, value-based account of authenticity. Our account draws on both existentialist and essentialist approaches to authenticity, and (...) Laura Waddell Ekstrom’s coherentist approach to personal autonomy. In developing our account, we respond to Sven Nyholm and Elizabeth O’Neill’s synchronic approach to authenticity, and explain how the diachronic approach we defend can have practical utility, contrary to Alexandre Erler and Tony Hope’s criticism of autonomy-based approaches to authenticity. Having drawn a distinction between the authenticity of an individual’s traits and the authenticity of that person’s values, we consider how our conception of authenticity applies to the context of anorexia nervosa in comparison to other prominent accounts of authenticity. We conclude with some reflections on the prudential value of authenticity, and by highlighting how the language of authenticity can be invoked to justify covert forms of paternalism that run contrary to the value of individuality that seems to be at the heart of authenticity. (shrink)

As clinical trials end, little is understood about how participants exiting from clinical trials approach decisions related to the removal or post-trial use of investigational brain implants, such as deep brain stimulation (DBS) devices. This empirical bioethics study examines how research participants experience the process of exit from research at the end of clinical trials of implanted neural devices. Using a modified grounded theory study design, we conducted semi-structured, in-depth interviews with 16 former research participants from clinical trials of DBS (...) and responsive neurostimulation (RNS). Open-ended questions elicited motivations for joining the trial, understanding of study procedures at the time of initial informed consent, the process of exiting from research, and decisions about device removal or post-trial device use. Thematic analysis identified categories related to: limited preparedness for the end of research participation, straightforwardness of decisions to explant or keep the device, reconciling with the end of research participation, reconciling post-trial expectations, and achieving a sense of closure after exit from research. A preliminary theoretical model describes contextual factors influencing the process and experience of exit from research. Experiences of clinical trial participants should guide research practices to enhance the ethical design and conduct of clinical trials in DBS and other brain devices. (shrink)

Invasive neural devices offer novel prospects for motor rehabilitation on different levels of agentive behavior. From a functional perspective, they interact with, support, or enable human intentional actions in such a way that movement capabilities are regained. However, when there is a technical malfunction resulting in an unintended movement, the complexity of the relationship between the end user and the device sometimes makes it difficult to determine who is responsible for the outcome – a circumstance that has been coined as (...) “responsibility gap” in the literature. So far, recent accounts frame this issue around the theme of control but more work is needed to explore the complicated terrain of assigning responsibility for neural device-mediated actions from this control perspective. This paper aims at contributing to this tendency by offering more fine-grained distinctions of how that control capacity is facilitated by the machine and how it can be exercised by the end user. This results in a novel framework that depicts an in-depth exploration of the control aspect of responsibility in a way that incorporates the diversity of relationships between neurotechnologies, the various conditions they treat, and the individual end user’s experience. (shrink)

Patients with amyotrophic lateral sclerosis (ALS) 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: (1) the extent to which each may rely on the other leaves their wellbeing intimately intertwined and (2) 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)

In this article, I explore select case studies of Parkinson patients treated with deep brain stimulation in light of the notions of alienation and authenticity. While the literature on DBS has so far neglected the issues of authenticity and alienation, I argue that interpreting these cases in terms of these concepts raises new issues for not only the philosophical discussion of neuro-ethics of DBS, but also for the psychological and medical approach to patients under DBS. In particular, I suggest that (...) the experience of alienation and authenticity varies from patient to patient with DBS. For some, alienation can be brought about by neurointerventions because patients no longer feel like themselves. But, on the other hand, it seems alienation can also be cured by DBS as other patients experience their state of mind as authentic under treatment and retrospectively regard their former lives without stimulation as alienated. I argue that we must do further research on the relevance of authenticity and alienation to patients treated with DBS in order to gain a deeper philosophical understanding, and to develop the best evaluative criterion for the behavior of DBS patients. (shrink)

In this article, we explore how deep brain stimulation (DBS) devices designed to “close the loop”—to automatically adjust stimulation levels based on computational algorithms—may risk taking the individual agent “out of the loop” of control in areas where (at least apparent) conscious control is a hallmark of our agency. This is of particular concern in the area of psychiatric disorders, where closed-loop DBS is attracting increasing attention as a therapy. Using a relational model of identity and agency, we consider whether (...) DBS designed for psychiatric regulation may require special attention to agency. To do this, we draw on philosophical work on relational identity and agency, connecting it with reports from people using first-generation DBS devices for depression and obsessive-compulsive disorder. We suggest a way to extend a notion of relational agency to encompass neural devices. (shrink)

The field of Neuro-Engineering seems to be on the fast track towards accomplishing its ultimate goal of potentially replacing the nervous system in the face of disease. Meanwhile, the patients and professionals involved are continuously dealing with human bodily experience and especially how neuro-engineering devices could become part of a user’s body schema: the domain of ‘embodied phenomenology’. This focus on embodiment, however, is not sufficiently reflected in the current literature on ethical and philosophical issues in neuro-engineering. In this article (...) we will focus on this lacuna by explaining existing data on neuro-engineering user’s experiences by using phenomenological concepts such as transparency and the concepts that may facilitate this: functionality, sensorimotor feedback and affective tolerance. By introducing and applying these concepts to four real life case examples, we will discuss practical implications and guidelines which can contribute to the actual success of incorporation of the device by the patient. First, we will discuss the importance of a ‘Patient Preference Diagnosis’, which can serve as a way to prepare the patient for the existential reorientation involved in the process. In addition, a Patient Transparency Diagnosis during and after such a process is also relevant when wanting to provide the medical field in general with feedback, and the patient in particular with possibilities to fine-tune the device. From these practical guidelines we will conclude that the phenomenological approach can be very valuable when applied to the field of neuro-engineering. (shrink)

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)

The article shows where the argument of responsibility-gap regarding brain-computer interfaces acquires its plausibility from, and suggests why the argument is not plausible. As a way of an explanation, a distinction between the descriptive third-person perspective and the interpretative first-person perspective is introduced. Several examples and metaphors are used to show that ascription of agency and responsibility does not, even in simple cases, require that people be in causal control of every individual detail involved in an event. Taking up the (...) current debate on liability in BCI use, the article provides and discusses some rules that should be followed when potentially harmful BCI-based devices are brought from the laboratory into everyday life. (shrink)