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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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Copyright Statement
© 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 |
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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 |
Downloads: | 0 |
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