Mr Nathan Higgins1
1Monash University
Background: Clinical trials of neural implants are rapidly growing and diversifying. However, little attention has been paid to ethical issues of post-trial responsibility. Researchers have reported a lack of guidance on best practices, with post-trial access often depending on the success of the trial, the regulatory status of the device, and the availability of coverage. The aim of this study is to investigate standard practices in the planning and provision of post-trial care.
Methods: Trial professionals were invited to complete a survey on post-trial care common practices. We conducted a systematic review of PUBMED and the International Clinical Trials Registry Platform to identify interventional trials conducted in the last 5-years. We collected the names and emails of authors (PUBMED) and “responsible parties” (ICTRP) from records that met inclusion criteria. We also recruited clinicians and researchers from our institution with known trial experience.
Results and Conclusion: Participants were from psychiatry, neuropsychology, neurology, neurosurgery, and clinical administration, with a mean of 12.82 years of experience. In the trials our sample reported on, “all” or “most” trial participants remained implanted after the end of the trial. Participants reported the most common barriers to ongoing care were lack of funding (69%), of expertise (59%), and geographical isolation (41%). They overwhelmingly (96%) supported an ethical obligation to provide post-trial care, and all (100%) believed it should be mandatory to prepare detailed plans of post-trial care arrangements. Greater exposure to the barriers to post-trial care is essential to ethical and pragmatic discussions about continued stakeholder responsibilities.
Biography:
Nathan is a PhD student at the School of Psychological Sciences at Monash University. He works in the emerging field of Neuroethics, where his research focuses on the responsible development and dissemination of novel brain implants.