TY - JOUR
T1 - Informed Consent in Implantable BCI Research
T2 - Identifying Risks and Exploring Meaning
AU - Klein, Eran
N1 - Funding Information:
The author is grateful to Sara Goering and Laura Specker Sullivan for helpful comments. This work was supported by Award Number EEC-1028725 from the National Science Foundation. The content is solely the responsibility of the author and does not necessarily represent the official views of the National Science Foundation.
Publisher Copyright:
© 2015, Springer Science+Business Media Dordrecht.
PY - 2016/10/1
Y1 - 2016/10/1
N2 - Implantable brain–computer interface (BCI) technology is an expanding area of engineering research now moving into clinical application. Ensuring meaningful informed consent in implantable BCI research is an ethical imperative. The emerging and rapidly evolving nature of implantable BCI research makes identification of risks, a critical component of informed consent, a challenge. In this paper, 6 core risk domains relevant to implantable BCI research are identified—short and long term safety, cognitive and communicative impairment, inappropriate expectations, involuntariness, affective impairment, and privacy and security. Work in deep brain stimulation provides a useful starting point for understanding this core set of risks in implantable BCI. Three further risk domains—risks pertaining to identity, agency, and stigma—are identified. These risks are not typically part of formalized consent processes. It is important as informed consent practices are further developed for implantable BCI research that attention be paid not just to disclosing core research risks but exploring the meaning of BCI research with potential participants.
AB - Implantable brain–computer interface (BCI) technology is an expanding area of engineering research now moving into clinical application. Ensuring meaningful informed consent in implantable BCI research is an ethical imperative. The emerging and rapidly evolving nature of implantable BCI research makes identification of risks, a critical component of informed consent, a challenge. In this paper, 6 core risk domains relevant to implantable BCI research are identified—short and long term safety, cognitive and communicative impairment, inappropriate expectations, involuntariness, affective impairment, and privacy and security. Work in deep brain stimulation provides a useful starting point for understanding this core set of risks in implantable BCI. Three further risk domains—risks pertaining to identity, agency, and stigma—are identified. These risks are not typically part of formalized consent processes. It is important as informed consent practices are further developed for implantable BCI research that attention be paid not just to disclosing core research risks but exploring the meaning of BCI research with potential participants.
KW - Brain–computer interface (BCI)
KW - Deep brain stimulation (DBS)
KW - Informed consent
KW - Neuroethics
KW - Research ethics
KW - Safety
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U2 - 10.1007/s11948-015-9712-7
DO - 10.1007/s11948-015-9712-7
M3 - Article
C2 - 26497727
AN - SCOPUS:84945161787
SN - 1353-3452
VL - 22
SP - 1299
EP - 1317
JO - Science and Engineering Ethics
JF - Science and Engineering Ethics
IS - 5
ER -