Unifying Consent Standards for Implantable Brain-Computer Interfaces.

Abstract

Implantable brain-computer interfaces (iBCIs) are approaching clinical deployment and can transform care for people with speech and motor impairment by restoring their ability in communication, movement, and aspects of agency. As a means of neurological intervention, iBCIs are not ethically or clinically analogous to current clinically established procedures or devices. They combine invasive neurosurgery, continuous neural data capture, adaptive machine-learning-based decoding, software dependence, and functionality that can change over time. These features create distinctive ethical, legal, clinical, and practical challenges that conventional informed consent frameworks do not adequately address. In this review and analysis, we present a framework and checklist to help guide more consistent and comprehensive informed consent for iBCIs to strengthen respect for autonomy, align stakeholder expectations, reduce fragmentation across sites, and support ethically robust translation of iBCIs into clinical practice.