Evidence map›Paper›PMID 42780902›Full record

ArticleDevice2026

Unifying Consent Standards for Implantable Brain-Computer Interfaces.

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

Abstract read
In one paragraph

Article in Device, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Michael J YoungCenter for Neurotechnology and Neurorecovery, Mass General Brigham Neuroscience Institute, Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.
Julian D SandbrinkHarvard Medical School, Boston, MA, USA; Charité Universitätsmedizin Berlin, Berlin, Germany.
Laura Y CabreraCenter for Neural Engineering, Department of Engineering Science and Mechanics, Rock Ethics Institute, The Pennsylvania State University, University Park, USA.
Komal KampasiBlackrock Neurotechnologies, Salt Lake City, Utah, USA.
Philip KennedyNeural Speech Inc, Duluth, GA.
Maryam MasoodCenter for Neurotechnology and Neurorecovery, Massachusetts General Hospital, Boston, Massachusetts, USA.
Daniel B RubinCenter for Neurotechnology and Neurorecovery, Massachusetts General Hospital, Boston, Massachusetts, USA.
Lynn BrielmaierPatient advocate, ALS Problem Solvers, NEALS Committees, Bridging Voice.
Paul FordCleveland Clinic, Cleveland, OH, USA.

Funding

Promoting Recovery from Brain Injury with Non-Invasive Thalamic UltrasoundK23NS140495 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI Michael J Young · 2025 to 2026
$469k
An Ethical Approach to Detecting Covert ConsciousnessF32MH123001 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI YOUNG, MICHAEL J · 2020 to 2022
$159k
NIMH NIH HHS F32 MH123001NINDS NIH HHS K23 NS140495
6 · The paper itself

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.

Indexed as

Brain-computer interface (BCI)neural interfacesneuroethicsneurologyneurotechnologypolicy

Identifiers

PMID42780902
PMCPMC13599423

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.