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International regulatory standards for the qualitative measurement of deep brain stimulation in clinical research

Citation

Stevens, I and Gilbert, F, International regulatory standards for the qualitative measurement of deep brain stimulation in clinical research, Journal of Empirical Research on Human Research Ethics, 17, (3) ISSN 1556-2654 (2022) [Refereed Article]


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The Author(s) 2022

DOI: doi:10.1177/15562646221094922

Abstract

Deep brain stimulation (DBS) has progressed to become a promising treatment modality for neurologic and psychiatric disorders like epilepsy and major depressive disorder due to its growing personalization. Despite evidence pointing to the benefits of DBS if tested on these personalized qualitative metrics, rather than randomized-control trial quantitative standards, the evaluation of these novel devices appears to be based on the latter. This study surveyed the presence of this trend in the national regulatory guidelines of the prominent DBS researching countries. It was found that two governing bodies, in the European Union and Australia, acknowledged the option for qualitative measures. These findings support further development of national regulatory guidelines, so the neuroscientific community developing these neurotechnologies can better understand the impact their treatments have on patients.

Item Details

Item Type:Refereed Article
Keywords:brain stimulation, qualitative research, federal regulation, clinical research
Research Division:Philosophy and Religious Studies
Research Group:Applied ethics
Research Field:Ethical use of new technology
Objective Division:Culture and Society
Objective Group:Ethics
Objective Field:Technological ethics
UTAS Author:Stevens, I (Mr Ian Stevens)
UTAS Author:Gilbert, F (Associate Professor Frederic Gilbert)
ID Code:149845
Year Published:2022
Deposited By:Philosophy and Gender Studies
Deposited On:2022-04-15
Last Modified:2022-06-20
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