While new generations of implantable brain computer interface (BCI) devices are being developed, evidence in the literature about their impact on the patient experience is lagging. In this article, we address this knowledge gap by analysing data from the first-in-human clinical trial to study patients with implanted BCI advisory devices. We explored perceptions of self-change across six patients who volunteered to be implanted with artificially intelligent BCI devices. We used qualitative methodological tools grounded in phenomenology to conduct in-depth, semi-structured interviews. Results show that, on the one hand, BCIs can positively increase a sense of the self and control; on the other hand, they can induce radical distress, feelings of loss of control, and a rupture of patient identity. We conclude by offering suggestions for the proactive creation of preparedness protocols specific to intelligent—predictive and advisory—BCI technologies essential to prevent potential iatrogenic harms.

Many scientists, healthcare providers, policymakers and patients are awaiting in anticipation the application of biomedical technologies such as functional neuroimaging for the prediction, diagnosis and treatment of mental disorders. The potential efficacy of such applications is controversial, and functional neuroimaging is not yet routinely used in psychiatric clinics. However, commercial ventures and enthusiastic reporting indicate a pressing need to engage with the social and ethical issues raised by clinical translation. There has been little investigation of how individuals living with mental illness view functional neuroimaging, or of the potential psychological impacts of its clinical use. We conducted 12 semi‐structured interviews with adults diagnosed with major depression or bipolar disorder, probing their experiences with mental health care and their perspectives on the prospect of receiving neuroimaging for prediction, diagnosis and planning treatment. The participants discussed the potential role of neuroimages in (i) mitigating stigma; (ii) supporting morally loaded explanations of mental illness due to an imbalance of brain chemistry; (iii) legitimising psychiatric symptoms, which may have previously been de‐legitimised since they lacked objective representation, through objective representations of disorder; and (iv) reifying DSM‐IV‐TR disorder categories and links to identity. We discuss these anticipated outcomes in the context of participant lived experience and attitudes to biologisation of mental illness, and argue for bringing these voices into upstream ethics discussion.

Researchers are rapidly developing and deploying highly portable MRI technology to conduct field-based research. The new technology will widen access to include new investigators in remote and unconventional settings and will facilitate greater inclusion of rural, economically disadvantaged, and historically underrepresented populations. To address the ethical, legal, and societal issues raised by highly accessible and portable MRI, an interdisciplinary Working Group (WG) engaged in a multi-year structured process of analysis and consensus building, informed by empirical research on the perspectives of experts and the general public. This article presents the WG’s consensus recommendations. These recommendations address technology quality control, design and oversight of research, including safety of research participants and others in the scanning environment, engagement of diverse participants, therapeutic misconception, use of artificial intelligence algorithms to acquire and analyze MRI data, data privacy and security, return of results and managing incidental findings, and research participant data access and control.