Continuing trial responsibilities for implantable neural devices

Saskia Hendriks; Nina Hsu; Andrea C Beckel-Mitchener; John Ngai; Christine Grady

doi:10.1016/j.neuron.2023.07.008

Continuing trial responsibilities for implantable neural devices

Neuron. 2023 Oct 18;111(20):3143-3149. doi: 10.1016/j.neuron.2023.07.008. Epub 2023 Aug 14.

Authors

Saskia Hendriks¹, Nina Hsu², Andrea C Beckel-Mitchener³, John Ngai³, Christine Grady⁴

Affiliations

¹ Office of Neuroscience Communications and Engagement, NINDS, NIH, Bethesda, MD, USA; Department of Bioethics, NIH Clinical Center, Bethesda, MD, USA. Electronic address: saskia.hendriks@nih.gov.
² Office of Neuroscience Communications and Engagement, NINDS, NIH, Bethesda, MD, USA.
³ NIH BRAIN Initiative, NIH, Bethesda, MD, USA.
⁴ Department of Bioethics, NIH Clinical Center, Bethesda, MD, USA.

PMID: 37582365
DOI: 10.1016/j.neuron.2023.07.008

Abstract

Participants of neural implant studies have research-related posttrial care needs (e.g., hardware replacements). Gaps in plans for posttrial care are currently common, which can have major consequences for patients. Professionals and organizations involved should address important unmet posttrial needs.

Keywords: brain; continued access; deep brain stimulation; ethics; implantable neurostimulators; neural device; neuroethics; neurotechnology; posttrial responsibilities; research ethics.

Published by Elsevier Inc.

Publication types

Research Support, N.I.H., Intramural

MeSH terms

Deep Brain Stimulation*
Humans
Implantable Neurostimulators
Prostheses and Implants