Adrian Carter

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.

Two competing views of addiction often frame debates about the legal responsibility of addicted persons for their drug use and crimes committed in order to use drugs: 1) the “brain disease model”; and 2) the commonsense view. The brain disease model suggests that addicted offenders may not be legally responsible for criminal behavior engaged in to fund drug use. According to the moral model they should be held responsible. The legal practice in Australia (as in most developed countries) represents a defensible pragmatic compromise between these two positions. Courts typically do not accept addiction as a defense in criminal cases but often use coerced treatment for addiction as an alternative to imprisonment. We describe the different ways in which this practice has been implemented and summarize evidence on its effectiveness. We conclude by considering how research on addiction may be used to improve legal practice in dealing with addicted offenders.

Following the recent surge in neurotechnology innovation and commercial investment, numerous academic bodies, government bodies, multilateral organizations, and industry leaders have produced ethical guidelines to govern neurotechnology innovation. Many highlight the need for new regulations to protect the rights and welfare of vulnerable individuals, while others warn about unnecessarily impeding innovation that provides urgent treatments to intractable conditions. Consensus on appropriate governance of neurotechnological innovation remains elusive. To fill this gap, we conducted a scoping review of the academic literature concerning the governance of neurotechnology development, identifying the ethical issues addressed, highlighting gaps or underdeveloped areas of neurotechnology governance, and the country in which they were developed. Fifty-one academic articles from the peer-reviewed literature were extracted, selecting those that referred to neurotechnologies and presented normative ethical guidelines or frameworks for their governance. We identified six common ethical themes (justice, beneficence and nonmaleficence, privacy and brain data, autonomy and informed consent, and, identity, dignity, and moral status) and six governance strategies proposed to address these themes (social responsibility and accountability, interdisciplinary collaboration, public engagement, scientific integrity, epistemic humility, legislation and neurorights). Discussions surrounding these themes lacked adequate consideration of diverse viewpoints, such as from the Global South, and were often underdeveloped, lacking both practical specificity and guidance to help developers balance competing priorities. Specifically, animal ethics and binding governance approaches were not adequately addressed, while neurorights were given undue consideration. Future guidelines should engage with these areas to aid in the development of more comprehensive and specific governance documents.

The rapid growth in psychedelic research raises novel ethical challenges for both research and psychedelic-assisted therapy. Despite these challenges, there is no consensus among researchers, clinicians, patients, and regulators on how these ethical issues may be avoided or managed. This study aimed to identify key ethical issues in psychedelic research and practice in the literature. A scoping review was performed, identifying fifty-one relevant articles. Content analysis revealed five main ethical concerns in the literature: 1) standards of practice, 2) equity, 3) integrity, 4) cultural appropriation, and 5) epistemic justice. A consultation workshop highlighted several key concerns that were neglected in the literature: 1) post-trial care, 2) lack of consensus on models of care and psychedelic practitioner competencies, and 3) how current research and its associated ethical issues will be translated into practice. Based on these findings the following future directions are recommended: designing clear competency frameworks, increased consultation with Indigenous and priority populations (e.g. ethnic and cultural minorities, under-served groups), guidelines for Indigenous recognition, management of post-trial care in clinical trials, and adequate governance of psychedelic prescribing practices.

Background Psychedelic medicine is a rapidly growing area of research and policy change. Australia recently became the first country to legalize the prescription of psychedelics and serves as a case study of issues that may emerge in other jurisdictions. Despite their influence as a stakeholder group, there has been little empirical exploration of psychedelic researchers’ views on the development of psychedelic research and the ethical concerns. Methods We thematically analysed fourteen interviews with Australian psychedelic researchers. Results Three themes were constructed from the data: 1) coming out of the shadow of the 1960s, 2) challenges and affordances in engaging stakeholders, and 3) growing pains in innovation and translation. Conclusion The results illustrated tensions arising from the rapid growth of psychedelic research from a small group of dedicated individuals with a similar worldview, to a multi-interest, regulated industry. Participants’ experiences and viewpoints were influenced by the history of psychedelic research, and this was met with an overarching concern for protecting the field from premature discontinuation, as well as maximizing potential positive impacts. Targets for stakeholder collaboration and initiatives to support responsible innovation in psychedelics include equitable access, sustainable industry involvement, productive research agendas, responsible reporting of evidence, and risk-taking within the relative safety of clinical trials.

The phenomenological effects of deep brain stimulation (DBS) on the self of the patient remains poorly understood and under described in the literature, despite growing evidence that a significant number of patients experience postoperative neuropsychiatric changes. To address this lack of phenomenological evidence, we conducted in-depth, semistructured interviews with 17 patients with Parkinson's disease who had undergone DBS. Exploring the subjective character specific to patients' experience of being implanted gives empirical and conceptual understanding of the potential phenomenon of DBS-induced self-estrangement. Our study concluded that (1) the more patients preoperatively felt alienated by their illness, the more they experienced postoperative self-estrangement, and (2) the notion of self-estrangement seems to exist in association with certain common qualitative characters, namely, loss of control, which reflects a deteriorative estrangement, and distorted perception of capacities, which reveals a restorative estrangement. These findings indicate that subjective self-reports help us to understand some aspects of the potential phenomenon of DBS-induced self-estrangement.

In recent decades, researchers have attempted to prospectively identify individuals at high risk of developing psychosis in the hope of delaying or preventing psychosis onset. These psychosis risk individuals are identified as being in an ‘At-Risk Mental State’ (ARMS) through a standardised psychometric interview. However, disclosure of ARMS status has attracted criticism due to concerns about the risk–benefit ratio of disclosure to patients. Only approximately one quarter of ARMS patients develop psychosis after three years, raising concerns about the unnecessary harm associated with such ‘false-positive’ results. These harms are especially pertinent when identifying psychosis risk individuals due to potential stigma and discrimination in a young clinical population. A dearth of high-quality evidence supporting interventions for ARMS patients raises further doubts about the benefit accompanying an ARMS disclosure. Despite ongoing discussion in the bioethical literature, these concerns over the ethical justification of disclosure to ARMS patients are not directly addressed in clinical guidelines. In this paper, we aim to provide a unified disclosure strategy grounded in principle-based analysis for ARMS clinicians. After considering the ethical values at stake in ARMS disclosure, and their normative significance, we argue that full disclosure of the ARMS label is favoured in the vast majority of clinical situations due to the strong normative significance of enhancing patients' understanding. We then compare our framework with other approaches to ARMS disclosure and outline its limitations.

Gilbert et al. argue that the neuroethics literature discussing the putative effects of Deep Brain Stimulation on personality largely ignores the scientific evidence and presents distorted claims that personality change is induced by the DBS stimulation. This study contributes to the first-hand primary research on the topic exploring DBS clinicians’ views on post-DBS personality change among their patients and its underlying cause. Semi-structured interviews were conducted with sixteen clinicians from various disciplines working in Australian DBS practice for movement disorders and/or psychiatric conditions. Thematic analysis of the interviews revealed five primary themes: 1) types, frequency and duration of personality change, 2) causes of personality change, 3) impact on patient and family, 4) communication, comprehension and awareness, and 5) management. Clinicians described a variety of personality changes in Parkinson’s disease following DBS including irritability, impulsivity and impaired decision-making. The frequency of personality change seen in patients varied amongst clinicians, but changes were overwhelmingly transient. Clinicians considered both DBS stimulation and additional factors as inducing personality change. For DBS patients with major depressive disorder, a restoration of pre-morbid personality was associated with alleviation of illness. Considerations for future research of personality change following DBS include selecting suitable tools for quantitative examination and developing a common language between the scientific and ethics communities. Clinical implications including recommendations for the informed consent process for patients and families and clinicians’ management of personality change are discussed.

Deep brain stimulation of the subthalamic nucleus for the treatment of Parkinson’s disease can lead to the development of neuropsychiatric symptoms. These can include harmful changes in mood and behaviour that alienate family members and raise ethical questions about personal responsibility for actions committed under stimulation-dependent mental states. Qualitative interviews were conducted with twenty participants following subthalamic DBS at a movement disorders centre, in order to explore the meaning and significance of stimulation-related neuropsychiatric symptoms amongst a purposive sample of persons with PD and their spousal caregivers. Interview transcripts underwent inductive thematic analysis. Clinical and experiential aspects of post-DBS neuropsychiatric symptoms were identified. Caregivers were highly burdened by these symptoms and both patients and caregivers felt unprepared for their consequences, despite having received information prior to DBS, desiring greater family and peer engagement prior to neurosurgery. Participants held conflicting opinions as to whether emergent symptoms were attributable to neurostimulation. Many felt that they reflected aspects of the person’s “real” or “younger” personality. Those participants who perceived a close relationship between stimulation changes and changes in mental state were more likely to view these symptoms as inauthentic and uncontrollable. Unexpected and troublesome neuropsychiatric symptoms occurred despite a pre-operative education programme that was delivered to all participants. This suggests that such symptoms are difficult to predict and manage even if best practice guidelines are followed by experienced centres. Further research aimed at predicting these complications may improve the capacity of clinicians to tailor the consent process.