Mr Nathan Higgins1
1School of Psychological Sciences, Monash University, Clayton, Australia
Biography:
Nathan Higgins is a PhD candidate at the Turner Institute for Brain and Mental Health, Monash University. His work focuses on the responsible research and innovation of neurotechnologies, with an emphasis on ethical issues related to post-trial access to implantable neural devices.
Abstract:
Aims:
Trials of neural implants are growing and diversifying. Deep Brain Stimulation continues to be explored for psychiatric and neurological disorders, and a suite of novel brain-computer interfaces are entering pivotal trials. These technologies raise unique ethical concerns related to post-trial care responsibilities. Recent case studies suggest some patients receive ongoing post-trial care, whereas others are explanted when the sponsor discontinues development of the device. The present study explored the experiences of neural implant investigators on how they prepared for and mitigated barriers to post-trial care.
Methods:
Semi-structured interviews were conducted with 21 psychiatrists, neurologists, neurosurgeons, and bioengineers, averaging 16.5 years of experience in the field. Just over half had worked on trials of DBS; many had worked on first-in-human trials of neuroprostheses or brain-computer interfaces.
Results:
Six key themes relating to the descriptive and normative aspects of post-trial responsibility were identified. These themes showed that clinician-researchers assume an inordinate amount of post-trial responsibility in different domains. Investigators frequently struggled to sustain funding, cared for participants if the manufacturer went bankrupt, and absorbed the responsibilities of research staff that left the research program. All enacted a strong clinical obligation to ensure patients continued to receive care, albeit acknowledging the competitive realities of the neurotechnology translation ecosystem.
Conclusions:
Characterising trial factors and contingencies that frustrate the facilitation of post-trial care will enable investigators to anticipate these barriers to care. Ultimately, however, a framework of multi-stakeholder cooperation is needed to relieve inordinate investigator burden and protect patients from post-trial harms.