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Controlling brain cells with light: ethical considerations for optogenetic clinical trials


Gilbert, F and Harris, A and Kapsa, R, Controlling brain cells with light: ethical considerations for optogenetic clinical trials, AJOB Neuroscience, 5, (3) pp. 3-11. ISSN 2150-7740 (2014) [Refereed Article]

Copyright Statement

Copyright 2014 Taylor and Francis

DOI: doi:10.1080/21507740.2014.911213


Optogenetics is being optimistically presented in contemporary media for its unprecedented capacity to control cell behaviour 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 Parkinsonís 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 individualís 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 optogeneticsí 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 Details

Item Type:Refereed Article
Keywords:Optogenetics, Neuroethics, Brain Implants, Mind Control, Clinical trials, Safety & efficacy
Research Division:Philosophy and Religious Studies
Research Group:Applied ethics
Research Field:Ethical use of new technology
Objective Division:Expanding Knowledge
Objective Group:Expanding knowledge
Objective Field:Expanding knowledge in philosophy and religious studies
UTAS Author:Gilbert, F (Dr Frederic Gilbert)
ID Code:92423
Year Published:2014
Deposited By:School of Humanities
Deposited On:2014-06-18
Last Modified:2017-11-06
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