Regulating Posttrial Access to In-Dwelling Class III Neural Devices

Megan S. Wright; Joseph J. Fins

doi:10.1017/9781108975452.020

Regulating Posttrial Access to In-Dwelling Class III Neural Devices

Megan S. Wright
, Joseph J. Fins

Research output: Chapter in Book/Report/Conference proceeding › Chapter

1 Scopus citations

Abstract

We incorporate the perspectives of research participants in a clinical trial of DBS for TBI about investigator and sponsor responsibilities with respect to posttrial access to a functioning embedded medical device. We argue that investigators owe a duty of transparency about posttrial access to device maintenance, upgrades, or removal as part of an ongoing informed consent process.

Original language	English (US)
Title of host publication	The Future of Medical Device Regulation
Subtitle of host publication	Innovation and Protection
Publisher	Cambridge University Press
Pages	256-267
Number of pages	12
ISBN (Electronic)	9781108975452
ISBN (Print)	9781108838634
DOIs	https://doi.org/10.1017/9781108975452.020
State	Published - Jan 1 2022

All Science Journal Classification (ASJC) codes

General Social Sciences

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10.1017/9781108975452.020

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abstract = "We incorporate the perspectives of research participants in a clinical trial of DBS for TBI about investigator and sponsor responsibilities with respect to posttrial access to a functioning embedded medical device. We argue that investigators owe a duty of transparency about posttrial access to device maintenance, upgrades, or removal as part of an ongoing informed consent process.",

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Regulating Posttrial Access to In-Dwelling Class III Neural Devices

Abstract

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