Unifying consent standards for implantable brain-computer interfaces

Workgroup:  Ethics, Neural Data Privacy, and Data Security

Date Updated: 11 August 2026

Authors: Michael J. Young, Julian D. Sandbrink, Laura Y. Cabrera, Komal Kampasi, Philip Kennedy, Maryam Masood, Daniel B. Rubin, Lynn Brielmaier, & Paul J. Ford

Overview:

This is a peer-reviewed publication, presenting an iBCI informed consent checklist.

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.

Audience:

iBCI investigators, clinicians, industry, regulators, ethicists and participant advocates

Application:

The iBCI informed consent checklist does not replace or override existing local, national, or international laws, consent regulations, data governance policies, or institutional protocols, but rather highlights distinctive features of iBCIs and cognate consent processes that are not fully addressed by current general frameworks. Users of this framework should continue to adhere to foundational legal and ethical standards applicable in their jurisdiction, including but not limited to the Common Rule, Belmont Report, FDA regulations, HIPAA, GDPR, and applicable IRB procedures. The accompanying manuscript details the rationale for the iBCI-IC checklist’s design, highlight features likely to be unfamiliar or under-specified in current practice, and offers practical guidance for implementation in translational research studies, clinical trials, and early clinical use.