TY - JOUR
T1 - Informed consent in implantable BCI research
T2 - Identification of research risks and recommendations for development of best practices
AU - Klein, Eran
AU - Ojemann, Jeffrey
N1 - Publisher Copyright:
© 2016 IOP Publishing Ltd.
PY - 2016
Y1 - 2016
N2 - Objective. Implantable brain-computer interface (BCI) research promises improvements in human health and enhancements in quality of life. Informed consent of subjects is a central tenet of this research. Rapid advances in neuroscience, and the intimate connection between functioning of the brain and conceptions of the self, make informed consent particularly challenging in BCI research. Identification of safety and research-related risks associated with BCI devices is an important step in ensuring meaningful informed consent. Approach. This paper highlights a number of BCI research risks, including safety concerns, cognitive and communicative impairments, inappropriate subject expectations, group vulnerabilities, privacy and security, and disruptions of identity. Main results. Based on identified BCI research risks, best practices are needed for understanding and incorporating BCI-related risks into informed consent protocols. Significance. Development of best practices should be guided by processes that are: multidisciplinary, systematic and transparent, iterative, relational and exploratory.
AB - Objective. Implantable brain-computer interface (BCI) research promises improvements in human health and enhancements in quality of life. Informed consent of subjects is a central tenet of this research. Rapid advances in neuroscience, and the intimate connection between functioning of the brain and conceptions of the self, make informed consent particularly challenging in BCI research. Identification of safety and research-related risks associated with BCI devices is an important step in ensuring meaningful informed consent. Approach. This paper highlights a number of BCI research risks, including safety concerns, cognitive and communicative impairments, inappropriate subject expectations, group vulnerabilities, privacy and security, and disruptions of identity. Main results. Based on identified BCI research risks, best practices are needed for understanding and incorporating BCI-related risks into informed consent protocols. Significance. Development of best practices should be guided by processes that are: multidisciplinary, systematic and transparent, iterative, relational and exploratory.
KW - brain-computer interface
KW - deep brain stimulation, safety
KW - informed consent
KW - neuroethics
KW - research ethics
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U2 - 10.1088/1741-2560/13/4/043001
DO - 10.1088/1741-2560/13/4/043001
M3 - Review article
C2 - 27247140
AN - SCOPUS:84979519029
SN - 1741-2560
VL - 13
JO - Journal of Neural Engineering
JF - Journal of Neural Engineering
IS - 4
M1 - 043001
ER -