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What Happens After a Neural Implant Study? Neuroethics Expert Workshop on Post-Trial Obligations

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Abstract

What happens at the end of a clinical trial for an investigational neural implant? It may be surprising to learn how difficult it is to answer this question. While new trials are initiated with increasing regularity, relatively little consensus exists on how best to conduct them, and even less on how to ethically end them. The landscape of recent neural implant trials demonstrates wide variability of what happens to research participants after an neural implant trial ends. Some former research participants continue to receive support for their devices (e.g., battery and component replacements, software updates, etc.). Others, when safe, have their neural implants removed through surgical explantation. Still others continue to live with a deactivated neural implant embedded in their body. In the United States, there are no uniform requirements to provide services, of any kind, after an neural implant study ends, and other nations are similarly facing this challenge. The existence of a post-trial gap in an expanding neural implant research ecosystem invites obvious questions: What is owed to neural implant research participants post-trial, and why has providing it been so difficult to accomplish in practice? To take a step forward on this difficult issue, we assembled one group of stakeholders – researchers funded for neuroethics grants by the National Institutes of Health – to explore possible starting points on one topic: ethical guidance for post-trial care of research participants in neural implant trials. Based on shared concerns discussed in the expert workshop the current paper is a call to action. It reports the key areas of convergence from the meeting and highlights important next steps towards developing much needed guidance.

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Notes

  1. The objective of our project was to primarily engage with ethicists as one among a set of critical stakeholders, thereby differentiating it from NIH workshop. Policy development, which was the intention of the NIH meeting, often requires making compromises. Our choice of stakeholder (ethicists) reflects our conviction that finding areas of ethical convergence, if possible, is an important step towards developing sound policy.

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Funding

Ishan Dasgupta, Eran Klein, and Sara Goering received funding from the NIH (Project number 3RF1MH117800-01S3) to fund some of the work related to this manuscript.

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Authors and Affiliations

  1. Dana Foundation, New York, USA

    Ishan Dasgupta & Khara Ramos

  2. Oregon Health & Science University, Portland, OR, USA

    Eran Klein

  3. Pennsylvania State University, State College, PA, USA

    Laura Y. Cabrera

  4. University of California San Francisco, San Francisco, CA, USA

    Winston Chiong & Tobias Haeusermann

  5. University of California Los Angeles, Los Angeles, CA, USA

    Ashley Feinsinger

  6. Weill Cornell Medical College, New York, NY, USA

    Joseph J. Fins

  7. NIH Clinical Center Department of Bioethics, Bethesda, MD, USA

    Saskia Hendriks

  8. Harvard Medical School, Cambridge, MA, USA

    Gabriel Lázaro-Muñoz

  9. Case Western Reserve University, Cleveland, OH, USA

    Cynthia Kubu

  10. Icahn School of Medicine at Mt. Sinai, New York, NY, USA

    Helen Mayberg

  11. Dartmouth College, Hanover, NH, USA

    Adina Roskies

  12. Cleveland Clinic, Cleveland, OH, USA

    Lauren Sankary

  13. Massachusetts General Hospital, Boston, MA, USA

    Ashley Walton

  14. University of Minnesota, Minneapolis, MN, USA

    Alik S. Widge

  15. University of Washington, Seattle, WA, USA

    Sara Goering

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  1. Ishan Dasgupta
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Correspondence to Ishan Dasgupta.

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Dasgupta, I., Klein, E., Cabrera, L.Y. et al. What Happens After a Neural Implant Study? Neuroethics Expert Workshop on Post-Trial Obligations. Neuroethics 17, 22 (2024). https://doi.org/10.1007/s12152-024-09549-2

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