Post-Trial Access to Implantable Neural Devices: An International Survey of Investigator Experiences and Ethical Perspectives
Nathan Higgins1, John Gardner1, Anna Wexler2, Philipp Kellmeyer3, Adrian Carter1, Monash University Melbourne2, 3, 1Monash University, Melbourne, Victoria, Australia2University of Pennsylvania 3University Medical Centre Freiburg
Abstract
Clinical trials of implantable neural devices are rapidly increasing and diversifying, but little is known about participants’ post-trial access to the device and ongoing clinical care. We investigated standard practices in the planning and coordination of post-trial care across the invasive neuromodulation sector. This study also explores the perspectives of trial investigators on barriers to post-trial access and ongoing care, as well as key ethical questions related to stakeholder responsibilities. Investigators were invited to complete a survey on post-trial access arrangements in the most recent investigational trial of a neural implant they had conducted. Survey respondents predominantly specialized in neurosurgery, neurology, and psychiatry, with a mean of 14.8 years of experience working with implantable neural devices. We found that either ‘all’ (64%) or ‘most’ (33%) trial participants had remained implanted after the end of the trial, with ‘infection’ and ‘non-response’ the most common reasons for device removal. When asked to describe the main barriers to providing post-trial care, investigators described limited funding, scarcity of expertise and specialist clinical infrastructure, and difficulties maintaining stakeholder relationships. Notwithstanding these barriers, investigators overwhelmingly (96%) agreed that there is an ethical obligation to provide post-trial access when participants personally benefit during the trial. Further research into common and standard practices in the post-trial phase is essential to ethical and pragmatic discussions about ongoing stakeholder responsibilities.
Biography
Nathan Higgins is a PhD student at the Turner Institute for Brain and Mental Health, Monash University. His research focuses on neuroethical considerations in the responsible research and development of novel neurotechnologies.