Evidence map›Paper›PMID 41686108›Full record

ReviewNeuromodulation : journal of the International Neuromodulation Society2026

Ethical Guidance for Investigational Implantable Neural Device Studies: Recommendations for Researchers and Research Ethics Committees.

Odile C van Stuijvenberg, Katherine C Bassil, Cecile C de Vos, Geert Geleijnse, Herke-Jan Noordmans, Marike L D Broekman, Rieke van der Graaf, Roland M Bertens, Gabriel Lázaro-Muñoz, Karin R Jongsma

Abstract readReview
In one paragraph

Review in Neuromodulation : journal of the International Neuromodulation Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

10 authors.

Odile C van StuijvenbergBioethics & Health Humanities, University Medical Centre Utrecht, Utrecht, The Netherlands.
Katherine C BassilBioethics & Health Humanities, University Medical Centre Utrecht, Utrecht, The Netherlands.
Cecile C de VosBioethics & Health Humanities, University Medical Centre Utrecht, Utrecht, The Netherlands.
Geert GeleijnseBioethics & Health Humanities, University Medical Centre Utrecht, Utrecht, The Netherlands.
Herke-Jan NoordmansBioethics & Health Humanities, University Medical Centre Utrecht, Utrecht, The Netherlands.
Marike L D BroekmanBioethics & Health Humanities, University Medical Centre Utrecht, Utrecht, The Netherlands.
Rieke van der GraafBioethics & Health Humanities, University Medical Centre Utrecht, Utrecht, The Netherlands.
Roland M BertensBioethics & Health Humanities, University Medical Centre Utrecht, Utrecht, The Netherlands.
Gabriel Lázaro-MuñozBioethics & Health Humanities, University Medical Centre Utrecht, Utrecht, The Netherlands.
Karin R JongsmaBioethics & Health Humanities, University Medical Centre Utrecht, Utrecht, The Netherlands. Electronic address: k.r.jongsma@umcutrecht.nl.

Funding

Post-trial Access, Clinical Care, Psychosocial Support, and Scientific Progress in Experimental Deep Brain Stimulation ResearchR01MH133657 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI Joseph J. Fins, Gabriel Lazaro-Munoz · 2023 to 2026
$1.9M
NIMH NIH HHS R01 MH133657
6 · The paper itself

Abstract

objectivesClinical studies of implantable neural devices raise unique ethical and legal challenges owing to the distinctive nature of these technologies and their research contexts. Persistent issues such as inadequate posttrial arrangements, psychologic risks, and study team roles have been highlighted in the literature. This study aims to address ongoing ethical challenges in clinical studies of implantable neural devices by providing practical recommendations for researchers and research ethics committees (RECs). MATERIALS AND

methodsBased on the synthesis of a comprehensive review of academic literature, existing ethical and legal guidelines, empirical studies, and input from various stakeholders, recommendations and their practical translation for RECs and researchers have been formulated.

resultsThe study presents recommendations organized into five central themes: 1) the study team, 2) participant selection and recruitment, 3) informed consent processes, 4) risk-benefit assessment, and 5) posttrial responsibilities. Moreover, two procedural recommendations aim to enhance REC review processes specific to investigational implantable neural devices studies.

conclusionsThese recommendations offer actionable guidance to help researchers align protocols with ethical and legal standards, and to assist RECs in anticipating and mitigating ethical risks in clinical studies involving implantable neural devices.

Indexed as

Biomedical ResearchImplantable NeurostimulatorsTherapies, InvestigationalClinical Studies as TopicEthics Committees, ResearchHumansInformed ConsentPatient SelectionPractice Guidelines as TopicResearch DesignResearch PersonnelEthical guidelineslegal standardsneural devicesrecommendationsresearch ethics committees

Identifiers

PMID41686108
PMCPMC13110431

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.