REVIEW article
Front. Hum. Neurosci.
Sec. Brain-Computer Interfaces
Volume 19 - 2025 | doi: 10.3389/fnhum.2025.1633627
This article is part of the Research TopicSocio-Legal, Ethical, Technical and Medical Considerations on Neuroprivacy and Brain-Machine Interaction Technologies in the era of A.I.View all 11 articles
Mind the Gap: Bridging Ethical Considerations and Regulatory Oversight in Implantable BCI Human Subjects Research
Provisionally accepted
- 1WCG Clinical, Cary, North Carolina, United States
- 2Michigan State University, East Lansing, United States
- 3University of Washington, Seattle, United States
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The advent of Brain-Computer Interface (BCI) technology brings groundbreaking advancements in medical science but also raises important ethical considerations. This manuscript explores the ethical dimensions of implantable BCIs (iBCIs), focusing on the central role of Institutional Review Boards (IRBs) in the United States, in safeguarding participant rights and welfare. As federally mandated bodies, IRBs ensure that informed consent is obtained ethically, emphasizing participant autonomy, preventing undue coercion, while supporting clear and practical communication of risks and benefits. As part of this discussion, this paper touches on the ethical challenges surrounding the enrollment of participants with impaired consent capacity and the long-term implications of implanted brain devices. Additionally, this work underscores the critical importance of robust cybersecurity measures to prevent data breaches and unauthorized manipulation of brain activity. By examining risk assessments, data management practices, and the need for external cybersecurity expertise, this work offers a comprehensive framework for IRB review of iBCI research. This perspective aims to guide ethical iBCI research and protect human subjects in this rapidly evolving field.
Keywords: Neural implants, Human subjects research, Institutional review board (IRB), Invasive BCI, Ethical Review, Investigational device exemption (IDE), Informed Consent, legally authorized representatives
Received: 22 May 2025; Accepted: 07 Jul 2025.
Copyright: © 2025 Wilkins, Coffin, Pham, Klein and Marathe. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Tara Coffin, WCG Clinical, Cary, North Carolina, United States
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