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Continued access to investigational brain implants

Nature Reviews Neuroscience volume 19, pages 317–318 (2018)Cite this article

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Brain implants are being trialled for their potential to ameliorate treatment-resistant conditions or to restore function. However, there are no clear guidelines for continued access to brain implants for trial participants whose symptoms improve with these devices.

Public and private research sponsors are investing in the development of next-generation deep brain stimulation (DBS) systems, brain–computer interfaces (BCIs) and neuroprosthetics. These devices aim to ameliorate serious treatment-resistant brain-related conditions or to restore function to individuals with disabling deficits. Often, participants in the trials of such technologies have suffered from their condition for many years and experienced several unsuccessful treatments. Device implantation exposes participants to the risks of neurosurgery and those associated with testing the device. Typically, much is done to protect against these risks. On the other hand, given the investigational nature of the device, the prospect of benefit for participants is far from assured. However, it remains unclear what happens at the end of the trial if a participant’s symptoms improve with the investigational device.

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Acknowledgements

The authors thank M. Husain and A. Viswanathan for helpful input about issues addressed in this article. Research for this article was funded by the US National Institute of Mental Health (grant R01-MH114854-01 to G.L.M.), the US National Eye Institute (grant R01-EY023336-04 to D.Y.) and the US National Institute of Neurological Disorders and Stroke (grant UH3-NS100549-01 to W.K.G.).

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Authors and Affiliations

  1. Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, USA

    Gabriel Lázaro-Muñoz & Amy L. McGuire

  2. Department of Neurosurgery, Baylor College of Medicine, Houston, TX, USA

    Daniel Yoshor

  3. Departments of Neurosurgery and Neuroscience, Baylor College of Medicine, Houston, TX, USA

    Michael S. Beauchamp

  4. Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA

    Wayne K. Goodman

Authors
  1. Gabriel Lázaro-Muñoz
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  2. Daniel Yoshor
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  3. Michael S. Beauchamp
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  4. Wayne K. Goodman
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  5. Amy L. McGuire
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Corresponding author

Correspondence to Gabriel Lázaro-Muñoz.

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The authors declare no competing interests.

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Related Links

CIOMS/WHO guidelines: https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf

NBAC report: https://bioethicsarchive.georgetown.edu/nbac/clinical/Vol1.pdf

Belmont Report: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/

The Dish: Participants as Partners: https://allofus.nih.gov/news-events-and-media/videos/dish-participants-partners

Participation: https://allofus.nih.gov/about/participation

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Lázaro-Muñoz, G., Yoshor, D., Beauchamp, M.S. et al. Continued access to investigational brain implants. Nat Rev Neurosci 19, 317–318 (2018). https://doi.org/10.1038/s41583-018-0004-5

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  • DOI: https://doi.org/10.1038/s41583-018-0004-5

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