Nathan Higgins

The issue of post‐trial responsibility is about what is owed to research participants after a clinical trial ends, who is responsible, and how long this responsibility must endure. Despite two decades of international guidance on this issue, research involving novel high‐risk interventions—such as implantable neurotechnologies—raises underexplored ethical tensions. Trials of implantable devices carry surgical risks and require access to multidisciplinary teams and specialised clinical infrastructures. These factors can foster participant dependence on investigator teams and trial institutions for post‐trial care and support. With research and development in this area accelerating, actionable ethical guidance on the post‐trial responsibilities of trial stakeholders is urgently needed. Recent normative commentaries have examined the post‐trial responsibilities of clinical trial investigators, who play a central role in study design, trial coordination, and follow‐up. A persistent challenge is demarcating investigator responsibilities of research integrity from those of therapeutic care when developing ethical guidance on post‐trial responsibilities. Recognising the value of empirical engagement for informing further ethical reflection, we conducted qualitative semi‐structured interviews with n = 21 investigators involved in neurosurgical device trials. We contend that investigators frequently experience institutional and regulatory pressures that shape how they interpret and enact responsibilities for participants' post‐trial wellbeing, often in ways that extend beyond standard expectations of clinical research practice.

Neurotechnology-derived data faces increasing challenges due to the lack of salient policy and regulatory guidance. Current legal frameworks produce inconsistencies in how data is regulated, which constrains both harmonization and standardization in the consumer domain. This Article begins by reviewing the current state of data protections in the United States that are relevant to consumer neurotechnology. It then examines the safeguards available within the European Union. As part of our comparative analysis, we assess how these legal frameworks apply to neural data collected by 47 different consumer neurotechnology wearables from 30 different companies. Our findings indicate that discrepancies in the definition of ‘neural data’ lead to differing levels of protection. Given that consumer neurotechnologies readily cross borders, such discrepancies may leave consumers exposed to devices developed under weaker protections, reinforcing the need for at least partial regulatory alignment. While establishing a universal definition of ‘neural data’ is conceptually appealing, we argue that it should not distract from the broader issues that give rise to the need for such a definition in the first place. Ultimately, our research suggests that policymakers may be better served by regulating the outcomes of data use rather than focusing exclusively on the data’s origin. Such an approach could better address the tension between promoting innovation, protecting individual rights, and ensuring product safety.

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.

Molecular epidemiology (ME) is a field that integrates molecular biology techniques with traditional epidemiological methods to study the distribution, determinants, and dynamics of disease. In the context of HIV, ME involves analysing genetic sequences of the virus to understand patterns of transmission, evolution, and the relationships between social, behavioural, and biological factors that influence transmission. This holds great promise in the global effort to further reduce HIV transmission, although its use raises significant ethical issues. ME is not currently used in Australia’s public health response to HIV, although experiences from other countries emphasize the importance of community consultation and support to avoid unintended negative consequences, such as deterring individuals from accessing sexual health services. This article explores the perspectives of twenty-three participants, recruited through HIV/sexual health-related organizations in Victoria, Australia, via nineteen semi-structured interviews and one focus group. Participants included people who regularly test for sexually transmissible infections (STIs) and people diagnosed with HIV and/or syphilis/gonorrhoea. Participants often reported vague or no prior understanding of ME (19/23; 82.6 per cent); however, many of those with vague or no understanding were supportive (16/19; 84.2 per cent). A subset of participants raised concerns, including those related to privacy risks, misuse of data, and the disproportionate impact on marginalized groups. These findings reinforce the need for meaningful community engagement and safeguards for potential ethical use of ME in Australia.

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.

De Marco et al 1 argue that the standard account of medical ‘invasiveness’ (as ‘incision’ or ‘insertion’) fails to capture three aspects of its existing use, namely that invasiveness can come in degrees, often depends on features of alternative medical interventions and can be non-physical. They propose a new schematic account that suggests that medical interventions can possess ‘basic invasiveness’ (which can come in degrees and of which they suggest at least two types: physical and mental), and ‘threshold invasiveness’ which can depend on the alternatives a specific intervention is being compared with. While we agree that the standard account of invasiveness fails to capture existing use and are supportive of their aim, here we express scepticism about the practical utility of De Marco et al ’s revised account. Our scepticism concerns the application of De Marco et al’s revised account in the narrow context of clinician–patient communication and deliberation about medical interventions within clinical practice, which we see as a crucial context for its use. While De Marco et al do not specify the contexts in which their revised account could be used, we assume from their discussion of treatment interventions (e.g. non-invasive prenatal testing, ventilation) and their comparison to ‘more or less invasive’ options, that at least one of the purposes in mind for …