Lilyana Levy

Background One of the central goals of recent neuroethics research is to understand the ethical implications that rapidly evolving neuroscientific discoveries and technologies may have for research participants, patients, and society. From adequate informed consent and post-trial obligations to impacts on agency and disability justice, neuroethicists have argued that the unique clinical, investigative, and financial context of these advances raises distinct and urgent ethical challenges. While much of the ethics work has been advanced through soliciting the perspectives of patients, participants, and the broader public, comparatively little work has explored the experiences of researchers who lead these studies, what ethical issues they face, and how they navigate them. Compared to other parties, investigators are uniquely situated with respect to both their agency and experience. They are the only stakeholders who experience ethical issues before, during, and after a study, and who interact with industry, universities, federal agencies, funders, IRBs, medical centers, ethicists, patients, participants, and caregivers. They are also in a position to determine, with relative authority, the designs of their studies and the solutions to ethical issues as they arise. Understanding researcher experiences is thus a critical part of recognizing, navigating, and mitigating the ethical issues that arise in cutting edge brain research. Methods We conducted a qualitative study with 14 NIH BRAIN Initiative-funded investigators, whose research spans 11 institutions and which involves various kinds of invasive brain research with humans. Interviewees were asked about their experiences conducting research and responding to ethical challenges, navigating academic and commercial institutions, interacting with patients, participants, and other researchers, and engaging with neuroethicists. Interviews were coded and analyzed utilizing an inductive and semantic reflexive thematic analysis. Results Analyses of interviews yielded two main themes: (i) the difficulty of navigating complex conflicts of interest and (ii) the need for collaboration, community, and participation in neuroethics deliberation. Researchers describe facing multiple underappreciated structural and interpersonal conflicts of interest (including those from research funding, team structure, data collection and sharing obligations, commercialization, innovation, and the boundaries between research and care), as well as the need for increased engagement with participants, ethicists, and each other. Conclusions Drawing on this data, we argue that navigating ethical issues in cutting edge brain research requires a shift from focusing on promoting ethical guidelines to also promoting neuroethical competencies. More specifically, we argue that integrating the philosophical discipline of virtue ethics—which focuses on developing moral sensitivities, practical reasoning skills, and other ethical competencies—could provide better tools for addressing the ethical issues researchers face than regulations and rules alone. We conclude by suggesting two ways that neuroethicists and neuroscientists might move together towards a virtue ethical ideal: (i) promoting targeted neuroethics education and opportunities for participating in collective moral deliberation, and (ii) prioritizing engagement amongst researchers, ethicists, and study participants.

In recent years, participant engagement initiatives in research on implanted neural devices have significantly increased. However, there remains little consensus on the motivations, goals, and best practices for engagement efforts. Drawing on the concept of participatory epistemic injustice, we argue that one core ethical motivation for engagement is epistemic in nature. Based on their subject positions, participants should be key knowledge contributors to implanted neurotech research. Therefore, we argue, participants experience participatory epistemic injustice when their insights do not result in changes to or otherwise influence research protocols, device development, and task design. We contend that engagement can resist this type of injustice only if it establishes robust methods not only to gather but also to actively incorporate participant knowledge into the research and development process.

Visual cortical prostheses (VCPs) have the potential to provide artificial vision for visually impaired persons. However, the nature and utility of this form of vision is not yet fully understood. Participants in the early feasibility trial for the Orion VCP were interviewed to gain insight into their experiences using artificial vision, their motivations for participation, as well as their expectations and assessments of risks and benefits. Analyzed using principles of grounded theory and an interpretive description approach, these interviews yielded six themes, including: the irreducibility of benefit to device functionality, mixed expectations for short-term device functionality and long-term technological advancement of visual prostheses, and a broad range of risks, concerns, and fears related to trial participation. We argue that these narratives motivate a nuanced set of ethical considerations related to the complex relationship between functionality and benefit, the intersection of user experience with disability justice, and the import of expectations and indirect risks on consent.

Background: Patients undergoing invasive neurosurgical procedures offer researchers unique opportunities to study the brain. Deep brain stimulation patients, for example, may participate in research during the surgical implantation of the stimulator device. Although this research raises many ethical concerns, little attention has been paid to basic studies, which offer no therapeutic benefits, and the value of patient-participant perspectives.Methods: Semi-structured interviews were conducted with fourteen individuals across two studies who participated in basic intraoperative research during their deep brain stimulator surgery. Interviews explored interpretations of risks and benefits, enrollment motivations, and experiences of participating in awake brain research. Reflexive thematic analysis was conducted.Results: Seven themes were identified from participant narratives, including robust attitudes of trust, high valuations of basic science research, impacts of the surgical context, and mixed experiences of participation.Conclusion: We argue that these narratives raise the potential for a translational misconception and motivate intraoperative re-consent procedures.