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Ethical Considerations in Ending Exploratory Brain–Computer Interface Research Studies in Locked-in Syndrome

Published online by Cambridge University Press:  10 September 2018

ERAN KLEIN ,
BETTS PETERS  and
MATT HIGGER
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Abstract:

Brain–computer interface (BCI) is a promising technology for restoring communication in individuals with locked-in syndrome (LIS). BCI technology offers a potential tool for individuals with impaired or absent means of effective communication to use brain activity to control an output device such as a computer keyboard. Exploratory studies of BCI devices for communication in people with LIS are underway. Research with individuals with LIS presents not only technological challenges, but ethical challenges as well. Whereas recent attention has been focused on ethical issues that arise at the initiation of studies, such as how to obtain valid consent, relatively little attention has been given to issues at the conclusion of studies. BCI research in LIS highlights one such challenge: How to decide when an exploratory BCI research study should end. In this article, we present the case of an individual with presumed LIS enrolled in an exploratory BCI study. We consider whether two common ethical frameworks for stopping randomized clinical trials—equipoise and nonexploitation—can be usefully applied to elucidating researcher obligations to end exploratory BCI research. We argue that neither framework is a good fit for exploratory BCI research. Instead, we apply recent work on clinician-researcher fiduciary obligations and in turn offer some preliminary recommendations for BCI researchers on how to end exploratory BCI studies.

Keywords

Brain–computer interface (BCI)locked-in syndrome (LIS)exploratory researchrandomized clinical trials
Type
Articles
Information
Cambridge Quarterly of Healthcare Ethics , Volume 27 , Special Issue 4: Clinical Neuroethics , October 2018 , pp. 660 - 674
Copyright
Copyright © Cambridge University Press 2018 

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Footnotes

We are grateful to the research participant pair who worked with us on this project. This work was funded by National Institutes of Health (NIH) grant #2R01DC009834-06A1, National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) grant #90RE5017, and NSF #EEC 1028725, and NIH-5T32MH016259-38.

References

Notes

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50. Clarification of roles may require concomitant development of new terminology to label these roles. For example, the terms “team” and “team members” are ambiguous as to whether participants and caregivers are encompassed by these terms. Additional terminology may need to be adopted (e.g., the “researcher team,” which is subject to regulatory oversight versus the broader “project team,” which also includes research participants and caregivers). To avoid confusion in describing the current study, we have kept, somewhat reluctantly, to the convention of using “team” to only refer to traditional researchers (not the participant and family), in the case described here, a speech-language pathologist and two engineers.