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)

The article proposes a theoretical model to account for changes in self due to Deep Brain Stimulation. First, we argue that most existing models postulate a very narrow conception of self, and thus fail to capture the full range of potentially relevant DBS-induced changes. Second, building on previous work by Shaun Gallagher, we propose a modified ‘pattern-theory of self’, which provides a richer picture of the possible consequences of DBS treatment.

International institutions such as UNESCO are deliberating on a new standard setting instrument for neurotechnologies. This will likely lead to the adoption of a soft law document which will be the first global document specifically tailored to neurotechnologies, setting the tone for further international or domestic regulations. While some stakeholders have been consulted, these developments have so far evaded the broader attention of the neuroscience, neurotech, and neuroethics communities. To initiate a broader debate, this target article puts to discussion twenty-five (...) considerations and desiderata for recognition by a future instrument. They are formulated at different levels of abstraction, from the big picture to technical details, seek to widen the perspective of preparatory reports and transcend the narrow debate about “neurorights” which overshadows many richer and more relevant aspects. These desiderata are not an exhaustive enumeration but a starting point for discussions about what deserves and what requires protection by an international instrument. (shrink)

Deep brain stimulation (DBS) is an approved treatment for neurological diseases and a promising one for psychiatric conditions, which may produce spectacular results very quickly. It is also a powerful tool for brain research and exploration. Beyond an overview of the ethical and legal literature on this topic, this paper aims at showing that DBS is a compelling example for ethical-legal reflection, as it combines a highly technical surgical procedure, a complex active medical device and neuromodulation of the human brain (...) to restore lost abilities caused by a chronic and evolving disease. Some of the ethical and legal issues raised by DBS are not specific, but shed new light on medical ethics and law. Others are more DBS-specific, as they are linked to the intricacies of research and treatment, to the need to tune the device, to the patients’ control over the device and its effects and to the involvement of family caregivers. (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 article proposes a theoretical model to account for changes in self due to Deep Brain Stimulation. First, we argue that most existing models postulate a very narrow conception of self, and thus fail to capture the full range of potentially relevant DBS-induced changes. Second, building on previous work by Shaun Gallagher, we propose a modified ‘pattern-theory of self’, which provides a richer picture of the possible consequences of DBS treatment.

The critical aspects of deep brain stimulation are usually the focus of the ethical debate about the implantation of electrodes into the brain of patients with Parkinson’s disease. Above all, potential postoperative side effects on personality caused by DBS mark the debate. However, rehabilitation of agility and mobility by DBS can be posited against critical aspects. Therefore, the purpose of this article is to emphasize the hitherto neglected positive aspects of that technology. A detailed study of the rehabilitation of controlled (...) movements will thus be the object of this article. The possibility to move again in a controlled way will be discussed as freedom of movement. The concept freedom of movement is being linked to the observation of feelings of euphoria and joy that can occur after surgery for patients with PD stimulated in the subthalamic nucleus. This is done based on phenomenological analysis and qualitative interviews, in which the relation between freedom of movement and feelings of joy becomes clear. The aim here is to show that these feelings of exaltation express an essential feeling of freedom – a bodily felt freedom – which is grounded in movement and can be regained by STN-DBS. (shrink)

In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive (...) regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation. (shrink)

The capacity of next-generation closed-loop or adaptive deep brain stimulation devices to read and write shows great potential to effectively manage movement, seizure, and psychiatric disorders, and also raises the possibility of using aDBS to electively modulate mood, cognition, and prosociality. What separates aDBS from most neurotechnologies currently used for enhancement is that aDBS remains an invasive, surgically-implanted technology with a risk-benefit ratio significantly different when applied to diseased versus non-diseased individuals. Despite a large discourse about the ethics of enhancement, (...) no empirical studies yet examine perspectives on enhancement from within the aDBS research community. We interviewed 23 aDBS researchers about their attitudes toward expanding aDBS use for enhancement. A thematic content analysis revealed that researchers share ethical concerns related to safety and security; enhancement as unnecessary, unnatural or aberrant; and fairness, equality, and distributive justice. Most researchers felt that enhancement applications for DBS will eventually be technically feasible and that attempts to develop such applications for DBS are already happening. However, researchers unanimously felt that DBS ideally should not be considered for enhancement until researchers better understand brain target localization and functioning. While many researchers acknowledged controversies highlighted by scholars and ethicists, such as potential impacts on personhood, authenticity, autonomy and privacy, their ethical concerns reflect considerations of both gravity and perceived near-term likelihood. (shrink)