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Controlling Brain Cells With Light: Ethical Considerations for Optogenetic Clinical Trials

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Gilbert, F and Harris, A.R. and Kapsa, M.R.I (2014) Controlling Brain Cells With Light: Ethical Considerations for Optogenetic Clinical Trials. American Journal of Bioethics: Neuroscience, 5 (3). pp. 3-11. ISSN 2150-7740

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Abstract

Optogenetics is being optimistically presented in contemporary media for its unprecedented capacity to control cell behavior through the application of light to genetically modified target cells. As such, optogenetics holds obvious potential for application in a new generation of invasive medical devices by which to potentially provide treatment for neurological and psychiatric conditions such as Parkinson’s disease, addiction, schizophrenia, autism and depression. Design of a first-in-human optogenetics experimental trial has already begun for the treatment of blindness. Optogenetics trials involve a combination of highly invasive genetic and electronic interventions that results in irreversible and permanent modifications of an individual’s nervous system. Given its novelty, its uncertain benefit to patients, and its unique risk profile of irreversible physiological alteration, optogenetics requires a reassessment of the ethical challenges for protecting human participants in clinical trials, particularly at formative stages of clinical evaluation. This study explores the evolving ethical issues surrounding optogenetics’ potential harm to participants within trial design, especially focusing on whether Phase 1 trials should incorporate efficacy as well as safety endpoints in ways that are fair and respectful to research trial participants.

Item Type: Article
Keywords: genetics, human subjects, nervous system, neurodegenerative disorder, neurosurgery, optogenetics, clinical trials, Phase 1, first-in-human
Journal or Publication Title: American Journal of Bioethics: Neuroscience
Page Range: pp. 3-11
ISSN: 2150-7740
Identification Number - DOI: 10.1080/21507740.2014.911213
Additional Information:

Copyright 2014 Taylor and Francis

Date Deposited: 27 Aug 2014 04:01
Last Modified: 18 Nov 2014 05:04
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