By Guido Cassinadri and Marcello Ienca
Implantable brain-computer interfaces (iBCI) are implantable systems that record quantitative neural data and use them to deliver various responses such as therapeutic, diagnostic, or preventive interventions. BCIs have been used inter alia to predict seizures in epileptic patients by monitoring their neural data and either delivering electrical stimulation or alerting the patient when specific neural thresholds are reached, prompting them to take necessary medication. Implanted BCIs require maintenance in the form of battery replacement, recalibration, and software updates to function properly.
However, sponsors and investigators are not legally obligated to provide ongoing maintenance and technical support for neural implants unless such responsibilities are explicitly outlined in the trial agreement. In turn, the trial agreement and informed consent process do not usually include provisions for post-trial maintenance of the implanted BCI. As a result, patients may be forced to accept the explantation of the device after the trial, even if they do not wish to undergo the procedure, leaving them with no viable alternative. This reveals a regulatory gap concerning post-trial responsibilities and duties of sponsors and investigators towards implanted patients.
This shortcoming became apparent in 2013 with patient Rita Leggett, an Australian woman with epilepsy who underwent the unwanted explantation of her implanted advisory BCI system after the manufacturing company declared bankruptcy. This event profoundly impacted her emotional well-being and quality of life. She described the experience as traumatic and expressed a deep sense of loss, stating that she felt as though a part of herself had been taken away, something that could never be replaced.
Such outcomes can occur despite existing ethical guidelines for post-trial access to continued BCI maintenance. The CIOMS (Council for International Organizations of Medical Sciences) guidelines require sponsors and investigators to develop plans ensuring patients’ continued access to beneficial interventions. Similarly, the World Medical Association’s Declaration of Helsinki mandates “post-trial access for all participants who still need an intervention identified as beneficial in the trial”.
Considering the case of Ms Leggett, we propose defining the post-trial moral duties of sponsors and investigators toward implanted patients appealing to their neurorights. These fundamental human entitlements can be interpreted differently depending on various mental ontologies. We examine how integration with an advisory BCI system can be understood through two perspectives: a traditional view, which sees the mind as localized within the brain (INT), and the extended mind theory (EXT), which posits that the mind is jointly realized by brain and artificial processes.
The advisory BCI notified Ms Leggett whenever she going to experience an epileptic seizure, enabling her to take appropriate medications and plan her daily routine. In a structured phenomenological report, she described a deep connection with the implant, feeling as though it had become part of her, giving her new capacities such as decision-making, self-regulation, and planning, which allowed her to lead an almost normal life.
This suggests that her post-implant persona could be interpreted as an extended cognitive agent, where the BCI became a constitutive part of her self and mind. However, the conditions for mental extension are not easily defined, so a more cautious view would state that some of her cognitive capacities were highly dependent on the external contribution of the device.
The neurorights framework is particularly relevant here, protecting specific entitlements in the brain/mind domain that may not be covered by other rights. The right to cognitive liberty guarantees control over one’s mental states and processes using neurotools and the freedom from external interference. The lack of continuous technical support for Ms Leggett’s BCI undermined her positive freedom to control her brain and mind functions. Moreover, her negative freedom from coercion was violated since this lack of support would have exposed her to harm if she refused the explantation. Whether we adopt an internalist or externalist view of the mind, we argue that Ms Leggett’s right to cognitive liberty was violated.
The right to mental integrity protects from mental harm resulting from unathorized mental interference. From an internalist perspective, this right was violated as R lost a crucial contributor to her cognitive abilities, causing additional psychological distress. From the extended mind perspective, she lost a fundamental component of her identity and self. Similarly, her right to psychological continuity was violated under both views, as the BCI played a critical role in the mental states that shaped her identity.
Given the potential mental harm from non-voluntary explantation, we argue that the neurorights framework provides strong ethical and potentially legal grounds for ensuring the continuous technical maintenance of mind-supporting devices. Similarly, the extended mind theory helps us reveal emerging forms of harm and vulnerability, further strengthening the moral duty of sponsors and investigators to maintain these devices to prevent mental harm and preserve the patient’s sense of agency and self.
Paper title: Non-voluntary BCI Explantation: Assessing Possible Neurorights Violations in Light of Contrasting Mental Ontologies
Authors: Guido Cassinadri, Marcello Ienca
Affiliations: Sant’Anna School of Advanced Studies, Technical University of Munich
Competing interests: No competing interests
Social media accounts of post author(s):
https://www.linkedin.com/in/guido-cassinadri/
https://www.linkedin.com/in/marcello-ienca-794b2575/
X: @MarcelloIenca