Post-trial access to implantable neural devices

Clinical trials of neural implants are growing and diversifying. Established device platforms, such as Deep Brain Stimulation, continue to be explored for psychiatric and neurological disorders. A new generation of Brain-computer Interfaces for speech and movement disorders are transitioning from feasibility testing to multi-center pivotal trials. Clinical trials of these expensive and sophisticated technologies raise ethical concerns related to post-trial care responsibilities: Will trial patients have the option of keeping their implant after the trial ends? Do trial investigators have the capacity to continue offering specialist care? What is the scope of responsibilities for other trial stakeholders, such as industry sponsors, insurers, and government funders?

This research project aims to examine common practices in how neural device investigators plan and facilitate continuing access. The project explores the perspectives of investigators on the key barriers to continuing access, as well as normative perspectives on potential changes within the field that may usefully protect patients from harm, including amendments to institutional standards of practice, codes of conduct, or funding regulations.

Research questions:

1. What are the common practices in the planning and coordination of post-trial access to neurosurgical devices?
2. What barriers do trial investigators identify in the delivery of post-trial access and ongoing care for neurosurgical devices
3. What are their perspectives on the ethical responsibilities of key stakeholder groups?

Outputs:

Higgins, N., Gardner, J., Wexler, A., Kellmeyer, P., O'Brien, K., & Carter, A. (2024). Post-trial access to implantable neural devices: an exploratory international survey. BMJ Surgery, Interventions, & Health Technologies, 6(1). https://doi.org/10.1136/bmjsit-2024-000262

Higgins, N., Gardner, J., & Carter, A. (2022). Situating Empirical Bioethics in Discussions of Post-Trial Responsibility. AJOB neuroscience, 13(4), 227-229. https://doi.org/10.1080/21507740.2022.2126543

Higgins, N.L., Gardner, J., Carter, A. (2022). Recognizing a Plurality of Industry Perspectives in the Responsible Innovation of Neurotechnologies. AJOB Neuroscience, 13 (1).

https://doi.org/10.1080/21507740.2021.2001084

Conference presentations: 

Higgins, N.L. (APR 2024). “If there were more resources we could have done more”: Investigator perspectives on post-trial responsibilities in neural implant trials. Long talk. International Neuroethics Society Annual Meeting: Montreal, Quebec

Higgins, N.L. (NOV 2023). Post-trial access to invasive neurotechnologies. Short talk. Australasian Association of Bioethics and Health Law: Brisbane, Australia

Higgins, N.L. (DEC 2022). Post-trial access to invasive neurotechnologies. Short talk and poster presentation. Australian Neuroscience Society Annual Meeting: Melbourne, Australia

Higgins, N.L. (NOV 2022). Post-trial access to invasive neurotechnologies. Long talk. International Neuroethics Society Annual Meeting: Montreal, Quebec

Higgins, N.L. (FEB 2022). Post-trial access to invasive neurotechnologies. Short talk. 2nd Australasian Society for Philosophy and Psychology Conference: Queensland, Australia.