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Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning

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Abstract

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.

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Notes

  1. The list of core and exploratory risk domains are not exhaustive nor are they necessarily mutually exclusive, but are meant as a useful, first pass framework for mapping risk in BCI research. While this framework may be applicable to other areas of BCI research, such as non-implantable BCI (e.g., EEG, TMS, tCDS), extension beyond implantable BCI is not intended here.

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Acknowledgments

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.

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  1. Department of Philosophy and Center for Sensorimotor Neural Engineering, University of Washington, Seattle, WA, USA

    Eran Klein

  2. Department of Neurology, Oregon Health and Sciences University, Portland, OR, USA

    Eran Klein

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Klein, E. Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning. Sci Eng Ethics 22, 1299–1317 (2016). https://doi.org/10.1007/s11948-015-9712-7

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