Evidence map›Paper›PMID 40772250›Full record

ReviewFrontiers in human neuroscience2025

Mind the gap: bridging ethical considerations and regulatory oversight in implantable BCI human subjects research.

R Bert Wilkins, Tara Coffin, Michelle Pham, Eran Klein, Megh Marathe

Abstract readReview
In one paragraph

Review in Frontiers in human neuroscience, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
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

5 authors.

R Bert WilkinsWCG Clinical, Cary, NC, United States.
Tara CoffinWCG Clinical, Cary, NC, United States.
Michelle PhamCenter for Bioethics and Social Justice, Department of Medicine, Michigan State University, East Lansing, MI, United States.
Eran KleinDepartment of Philosophy, University of Washington, Seattle, WA, United States.
Megh MaratheDepartment of Media and Information, Center for Bioethics and Social Justice, Michigan State University, East Lansing, MI, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

ethical reviewhuman subjects researchimplantable BCIinformed consentinstitutional review board (IRB)investigational device exemption (IDE)legally authorized representativesneural implants

Identifiers

PMID40772250
PMCPMC12325254

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.