Fred 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.

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.

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.

Deep brain stimulation (DBS) is optimistically portrayed in contemporary media. This already happened with psychosurgery during the first half of the twentieth century. The tendency of popular media to hype the benefits of DBS therapies, without equally highlighting risks, fosters public expectations also due to the lack of ethical analysis in the scientific literature. Media are not expected (and often not prepared) to raise the ethical issues which remain unaddressed by the scientific community. To obtain a more objective portrayal of DBS in the media, a deeper collaboration between the science community and journalists, and particularly specialized ones, must be promoted. Access to databases and articles, directly or through science media centers, has also been proven effective in increasing the quality of reporting. This article has three main objectives. Firstly, to explore the past media coverage of leukotomy, and to examine its widespread acceptance and the neglect of ethical issues in its depiction. Secondly, to describe how current enthusiastic coverage of DBS causes excessive optimism and neglect of ethical issues in patients. Thirdly, to discuss communication models and strategies to enhance media and science responsibility.

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.

Deep brain stimulation (DBS) interventions are novel devices being investigated for the management of severe treatment-resistant psychiatric illnesses. These interventions require the invasive implantation of high-frequency neurostimulatory probes intracranially aiming to provide symptom relief in treatment-resistant disorders including obsessive-compulsive disorder and anorexia nervosa. In the scientific literature, these neurostimulatory interventions are commonly described as reversible and to be used as a last resort option for psychiatric patients. However, the ‘last resort’ status of these interventions is rarely expanded upon. Contrastingly, usages of DBS devices for neurological symptoms (eg, Parkinson’s disease, epilepsy or dystonia) have paved the way for established safety and efficacy standards when used earlier in a disease’s timeline. As DBS treatments for these neurological diseases progress to have earlier indications, there is a parallel ethical concern that early implementation may one day become prescribed for psychiatric illnesses. The purpose of this article is to build off contemporary understandings of reversible neurostimulatory interventions to examine and provide clarifications on the ‘last resort’ status of DBS to better address its ethically charged use in psychiatric neurosurgery. To do this, evaluative differences between DBS treatments will be discussed to demonstrate how patient autonomy would be a paramount guiding principle when one day implementing these devices at various points along a psychiatric disease’s timeline. In presenting the clarification of ‘last resort’ status, the ethical tensions of early DBS interventions will be better understood to assist in providing psychiatric patients with more quality of life years in line with their values.

Clinical trials aim to minimise participant risk and generate new clinical knowledge for the wider population. Many military agencies are now investing efforts in pushing towards developing new treatments involving Brain-Computer Interfaces, Gene Therapy and Stem Cells interventions. These trials are targeting smaller disease groups, as such they give rise to novel participant risks of harms that are largely not accommodated by existing practice. This is of most concern with irreversible harms at early trial stages, where participants may forfeit any future therapy, and in personalised medicine, where the individual participant assumes all of the trial risk. Given these new experimental interventions involve high risk of irreversible harms, how much risk should patients be exposed to when participating in experimental testing of innovative technologies? Designing clinical trials which better balance risk/benefit ratios for participants is crucial. The aim of this book chapter is to suggest a new stratified risk framework aimed at minimising the risk-benefit ratio to participants in clinical trials associated with high risk of irrevocable harms. We will argue it demands a higher-level of clinical data capture at earlier trial stages than predicated by current trial doctrine; it also requires publication of all trial data to minimise risk to participants of any future trial.

Purpose With the increasing sophistication of neuroimaging technologies in medicine, new language is being sought to make sense of the findings. The aim of this paper is to explore whether the brain-reading metaphor used to convey current medical or neurobiological findings imports unintended significations that do not necessarily reflect the genuine findings made by physicians and neuroscientists. Methods First, the paper surveys the ambiguities of the readability metaphor, drawing from the history of science and medicine, paying special attention to the sixteenth through nineteenth centuries. Next, the paper addresses more closely the issue of how metaphors may be confusing when used in medicine in general, and neuroscience in particular. The paper then explores the possible misleading effects associated with the contemporary use of the brain-reading metaphor in neuroimaging research. Results Rather than breaking new ground, what we see in current scientific language is a persistence of both a constraining and expansive set of language practices forming a relatively continuous tradition linking current neuroimaging to past scientific investigations into the brain. Conclusions The use of the readability metaphor thus carries with it both positive and negative effects. Physicians and neuroscientists must resort to the use of terms already laden with abstracted meanings, and often burdened by tradition, at the risk of importing through these words connotations that do not tally with the sought-after objectivity of empirical science

Although an invasive medical intervention, Deep Brain Stimulation (DBS) has been regarded as an efficient and safe treatment of Parkinson’s disease for the last 20 years. In terms of clinical ethics, it is worth asking whether the use of DBS may have unanticipated negative effects similar to those associated with other types of psychosurgery. Clinical studies of epileptic patients who have undergone an anterior temporal lobectomy have identified a range of side effects and complications in a number of domains: psychological, behavioural, affective and social. In many cases, patients express difficulty adjusting from being chronically ill to their new status as ‘treated’ or ‘seizure free’. This postoperative response adjustment has been described in the literature on epilepsy as the ‘Burden of Normality’ (BoN) syndrome. Most of the discussion about DBS postoperative changes to self is focused on abnormal side effects caused by the intervention (ie, hypersexuality, hypomania, etc). By contrast, relatively little attention is paid to the idea that successfully ‘treated’ individuals might experience difficulties in adjusting to becoming ‘normal’. The purpose of this paper is (1) to articulate the postoperative DBS psychosocial adjustment process in terms of the BoN syndrome, (2) to address whether the BoN syndrome illustrates that DBS treatment poses a threat to the patient’s identity, and (3) to examine whether the current framework for rehabilitation after DBS procedures should be updated and take into account the BoN syndrome as a postoperative self-change response.