Frederic Gilbert

The clinical development of implantable neural devices raises complex ethical questions about post-trial responsibilities to participants. Continued support for participants who continue to use investigational implantable neural devices requires ongoing specialist care, technical expertise, access to tertiary clinical infrastructure, and substantial financial resources to pay for the device and related procedures. However, continued access may not be possible if the trial shows no benefit, if financial barriers limit commercial viability, or if safety concerns lead to suspension or early termination. Specific ethical guidance on post-trial responsibility is urgently needed. To address this challenge within the Australian innovation context, we conducted a modified Delphi study with a multidisciplinary panel of 24 experts, including representatives from industry, bioethics, law, neurosurgery, clinical psychology/neuropsychology, clinical research, neural engineering, regulation and governance, and lived experience advocacy. The process involved two workshops and a survey, guided by established RAND/UCLA methods with context-specific modifications. Drawing on prior empirical research and regulatory review, the panel developed 11 consensus recommendations for responsible post-trial practices. All recommendations achieved high levels of agreement and were rated as highly important for addressing ethical risks in the Australian environment. These are the first jurisdiction-specific recommendations of their kind, and we anticipate they will substantially enhance ethical and practical standards for post-trial responsibility in implantable neural device research in Australia and internationally.

LLMs’ exceptional capabilities of language translation, sentence completion, sentiment analysis, information retrieval, and much more make them useful in a vast array of contexts, from customer service to scientific research. With these great technological possibilities come many unanswered questions and several concerns. We focus on the use of LLMs in epistemic contexts, broadly construed, meaning those contexts in which an LLM is used by a subject in order to fulfil their epistemic goals, such as acquiring justification, increasing their knowledge or understanding or developing argumentative work. By examining the epistemic context of LLMs, we aim to give an account of some of the epistemological risks associated with their usage.

Horizon scanning is intended to identify opportunities and threats associated with technology, regulatory, and social change. Here, we report the results of a new horizon scan based on inputs of an international group of 33 participants, focusing on future issues arising from the military use of artificial intelligence (AI) for augmenting human performance. The final list of 12 issues includes topics spanning from the political (educating and training individuals to accept and work with AI), to the regulatory (issues of consent to human-AI teaming and hybridization), to security (the hackability of neural devices that connect to AI), to philosophical (the nature and phenomenology of brain-to-brain interfaces). The early identification of such issues is relevant to researchers, policymakers, military practitioners, and the wider public.

Horizon scanning is intended to identify opportunities and threats associated with technology, regulatory, and social change. Here, we report the results of a new horizon scan based on inputs of an international group of 33 participants, focusing on future issues arising from the military use of artificial intelligence (AI) for augmenting human performance. The final list of 12 issues includes topics spanning from the political (educating and training individuals to accept and work with AI), to the regulatory (issues of consent to human-AI teaming and hybridization), to security (the hackability of neural devices that connect to AI), to philosophical (the nature and phenomenology of brain-to-brain interfaces). The early identification of such issues is relevant to researchers, policymakers, military practitioners, and the wider public.

From epileptic seizures to depressive symptoms, predictive neurotechnologies are used for a large range of applications. In this article we focus on advisory devices; namely, predictive neurotechnology programmed to detect specific neural events (e.g., epileptic seizure) and advise users to take necessary steps to reduce or avoid the impact of the forecasted neuroevent. Receiving advise from a predictive device is not without ethical concerns. The problem with predictive neural devices, in particular advisory ones, is the risk of seeing one’s autonomous choice supplanted by the predictions instead of being supplemented by it. For users, there is a potential shift from being assisted by the system to being over-dependent on the technology. In other terms, it introduces ethical issues associated with epistemic dependency. In this article, we examine the notion of epistemic authority in relation to predictive neurotechnologies. Section 1 of our article explores and defines the concept of epistemic authority. In section 2, we illustrate how predictive devices are best conceived of as epistemic authorities and we explore the subject-device epistemic relationship. In section 3, we spell out the risk of harms interconnected with epistemic deferral. We conclude by stressing a set of preliminary measures to prepare users for the authoritative nature of predictive devices.

Horizon scanning is intended to identify opportunities and threats associated with technology, regulatory, and social change. Here, we report the results of a new horizon scan based on inputs of an international group of 33 participants, focusing on future issues arising from the military use of artificial intelligence (AI) for augmenting human performance. The final list of 12 issues includes topics spanning from the political (educating and training individuals to accept and work with AI), to the regulatory (issues of consent to human-AI teaming and hybridization), to security (the hackability of neural devices that connect to AI), to philosophical (the nature and phenomenology of brain-to-brain interfaces). The early identification of such issues is relevant to researchers, policymakers, military practitioners, and the wider public.

The idea that deep brain stimulation (DBS) induces changes to personality, identity, agency, authenticity, autonomy and self (PIAAAS) is so deeply entrenched within neuroethics discourses that it has become an unchallenged narrative. In this article, we critically assess evidence about putative effects of DBS on PIAAAS. We conducted a literature review of more than 1535 articles to investigate the prevalence of scientific evidence regarding these potential DBS-induced changes. While we observed an increase in the number of publications in theoretical neuroethics that mention putative DBS-induced changes to patients’ postoperative PIAAAS, we found a critical lack of primary empirical studies corroborating these claims. Our findings strongly suggest that the theoretical neuroethics debate on putative effects of DBS relies on very limited empirical evidence and is, instead, reliant on unsubstantiated speculative assumptions probably in lieu of robust evidence. As such, this may reflect the likelihood of a speculative neuroethics bubble that may need to be deflated. Nevertheless, despite the low number of first-hand primary studies and large number of marginal and single case reports, potential postoperative DBS changes experienced by patients remain a critical ethical concern. We recommend further empirical research in order to enhance theoretical neuroethics work in the area. In particular, we call for the development of better instruments capable of capturing potential postoperative variations of PIAAAS.

There are increasing numbers of clinical trials assessing high-risk, irreversible treatments. Trial participants should only expect knowledge gain to society, no personal therapeutic benefit. However, participation may lead to long-term harms and prevent future therapeutic options. While some discussion has occurred around post-trial access to treatments for participants who received therapeutic benefit, there are no post-trial support requirements for those suffering long-term consequences from trial participation. Participants may be left with significant medical, psychological, social, technical or financial needs. All trials will end at some point, regardless of their success. Subsequently, they should be designed to take into account the post-trial period including the impact on the ongoing health of a participant and their post-trial needs.

In their paper “Deflating the neuroenhancement bubble”, more precisely in their section entitled “How New is Neuroenhancement?”, Lucke and colleagues argue that neuroenhancement is nothing new to our epoch by demonstrating that the use of psychoactive stimulants in the 19th and 20th centuries was already common. The purpose of our comment is to show that the current bubble surrounding neuroenhancement in particular, and enhancement in general, is a recasting of an even older speculative engagement that can be traced back from the 16th to the 18th centuries. As a consequence, there is a high risk that bioethicists might not have captured or found new conceptual challenges related to current enhancement debate. As well, by ignoring issues related to ancient debate, we argue that modern bioethicists risk spending effort on speculative ethics.

Postmortem evidence of chronic traumatic encephalopathy (CTE) in the brains of American National Football League players who suffered concussions while playing have intensified concerns about the risks of concussion in sport.1 Concussions are frequently sustained by amateur and professional players of Australia’s three most popular football codes (Australian football, rugby league, and rugby union) and, to a lesser extent, other contact sports such as soccer. This raises major concerns about possible long-term neurological damage, cognitive impairment and mental health problems in players of these sports.

Taiwan has a population of 23 million, of which some 500,000 are Aborigines. Recent conflicts over a national biobank as part of Taiwan's biotechnological industrial development, genetic research on Aboriginal origins, and commercialization of research findings involving Aborigines have raised a number of important ethical conflicts. These ethical conflicts involve on one hand, the importance of researchers' duties, and on the other hand, Aboriginal rights. This paper will go in three steps. First, this paper describes the three cases of ethical violations of Aboriginal rights committed by Taiwanese researchers in the course of their scientific duties. After having given an account of ethical conflicts between research duties and Aboriginal rights, the paper addresses larger ethical issues underlying this Taiwanese research context. Finally, the paper considers if stronger ethical regulation could reconcile Aboriginal rights and research duties

Haeusermann et al. (Citation2023) draw three overall conclusions from their study on closed loop neuromodulation and self-perception in clinical treatment of refractory epilepsy. The first is that closed-loop neuromodulation devices did not substantially change epileptic patient’s personalities or self-perception postoperatively. The second is that some patients and caregivers attributed observed changes in personality and self-perception to the epilepsy itself and not to the DBS treatments. The third is that the devices provided participants with novel ways to make sense of their illness. These findings further demonstrate a misalignment between some neuroethicists’ concerns about putative postoperative changes to personality, and the empirical evidence for such changes. Haeusermann et al. nonetheless concede that “neurotechnology directed at persisting rather than episodic clinical phenomena could have greater implications for personality or self-perception, either because they operate more continuously or are directed at clinical phenomena that are more stably integrated into patients’ self-concepts” (41). We acknowledge that the hypothesis that participants did not report changes because they were only episodically and not continually stimulated offers an interesting line for future investigation. Nonetheless, we would like to propose that potential postoperative personality changes might be correlated with the pathophysiology itself, rather than the stimulation effects of the technology. Generally, we advance the view that unintended effects solely induced by the technology cannot be excluded per se. Regardless, this comment aims to highlight that ethicists’ starting premise should be that patients suffering from diverse pathophysiology, or patients who are treated with stimulation in different brain regions and with differing parameters, would likely not react in the same way to treatment.

Many experimental brain-computer interfaces (BCIs) are currently being medically tested in paralyzed patients. While the new generations of implantable BCIs move rapidly ahead at trying to increase the patients’ well-being, ethical concerns about their potential effects on patients’ psychological dimensions (e.g. sense of agency and control) are growing. An important ethical concern to explore is how BCIs may introduce unprecedented vulnerabilities to implanted individuals.Our chapter shows that, on the one hand, BCIs can empower the sense of self and control, which contribute to well-being. On the other hand, they can introduce unprecedented vulnerabilities, for example, by inducing radical distress, feelings of loss of control, and a rupture of patient identity, which decrease one’s well-being. To investigate a possible solution to this problem we propose to understand the implementation of a BCI system in one’s body through the capability approach. This calls for a careful ethical examination of new morally salient issues prior to seeing an increase in BCI-related psychological effects in an open market.

Applying equity to health care is difficult and it is especially challenging when applied to cases that involve urgent military medicine care under resource scarcity. Part of the difficulty centers on the concept of equity itself. It is not clear what the best concept of equity applicable to medical care would be, or that there should be only one, or the same ones, across all levels of military health care. Despite the fact that equity is a key concern in health care, particularly in the age of the COVID-19 pandemic, it may be that there is no single theory of justice that would be most justified for military physicians to use. This paper examines whether a hybrid position of equity might be both theoretically robust and applicable in practice. After briefly introducing the discussion, we outline four major philosophical definitions of equity – (1) Egalitarianism, (2) Prioritarianism, (3) Desertism, and (4) Sufficientism. We then report empirical findings suggesting that a practice-based hybrid concept of equity is used by physicians within the practice of micro-allocation. Our findings will shed lights on ethical justifications and reasoning which should guide medical rules for military and humanitarian health care providers.

The purpose of this commentary is to address an ethical issue introduced by Walter Glannon regarding whether responsibility can be affected by the use of performance enhancing drugs. Glannon uses the example of a surgeon taking drugs to enhance her capacities. I explore whether conducting surgeries while under the influence of performance enhancing drugs will affect the surgeon’s responsibility for performing more surgeries ‘and’ the surgeon’s responsibility for assuming the consequences of performing these surgeries. Here, the ‘and’ is cumulative: one is responsible for performing ‘and’ one is responsible for having taken performance enhancing drugs. Given that such accumulation could be interpreted as “more responsible”, this might challenge Glannon’s conclusion and impact the normative practices associated with enhancement drugs.

Postmortem research on the brains of American tackle football players has revealed the presence of chronic traumatic encephalopathy (CTE), a degenerative brain disease caused by repeated head trauma. Repeated concussion is a risk factor for CTE, raising ethical concerns about the long-term effects of concussion on athletes at risk for football-related concussion. Of equal concern is that youth athletes are at increased risk for lasting neurocognitive and developmental deficits that can result in behavioral disturbances and diminished academic performance. In this article, we consider evidence of the effects of concussion in youth athletes, and discuss ethical duties to youth athletes and how these duties might be satisfied, given the intrinsic risks of football. Finally, we evaluate potential strategies for reducing concussions in junior football, and recommend the optimal strategy for reducing brain injury to an acceptable level while still making available the benefits of football participation for youth athletes.

Although being generally safe, the use of Deep Brain Stimulation has been associated with a significant number of patients experiencing postoperative psychological and neurological harm within experimental trials. A proportion of these postoperative severe adverse effects have lead to the decision to medically prescribe device deactivation or removal. However, there is little debate in the literature as to what is in the patient’s best interest when device removal has been prescribed; in particular, what should be the conceptual approach to ethically guide the decision to remove or maintain implants. The purpose of this article is to examine the ethical issues raised when patients refuse brain device explantation despite medical prescription. In order to illustrate these issues, we report and discuss a clinical case involving a patient suffering from treatment resistant depression who experienced forms of postoperative self-estrangement, as well as suicidal attempts, but who resists giving consent to device explantation

Recent developments of three-dimensional printing of biomaterials in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article considers whether there is a limit as to what should be bioprinted in medicine; examines key risks of significant harm associated with testing 3D bioprinting for humans; investigates the clinical trial paradigm used to test 3D bioprinting; analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.

In their article published in Nanoethics, “Ethical, Legal and Social Aspects of Brain-Implants Using Nano-Scale Materials and Techniques”, Berger et al. suggest that there may be a prima facie moral obligation to improve neuro implants with nanotechnology given their possible therapeutic advantages for patients [Nanoethics, 2:241–249]. Although we agree with Berger et al. that developments in nanomedicine hold the potential to render brain implant technologies less invasive and to better target neural stimulation to respond to brain impairments in the near future, we argue against presenting the development of nanobionic clinical devices in terms of a moral obligation to conduct this research. In the first part of the paper, we consider what a duty to pursue new technologies might mean, and in the second we explore some of the negative consequences of defending such development as a moral obligation based on potential benefit. We argue that promoting the advances available to brain implants through developments in nanotechnology and bionics could contribute to medical rhetoric that indirectly increases the risk of exposing patients to harm when participating in clinical trials. We argue that rather than there being a moral obligation to improve nanobionics implants because of their potential benefit, the pursuit of improved neuro implants must be balanced against the prima facie obligations to protect patients against harm and to promote and protect patient autonomy