Speaker: Saskia Hendriks, M.D., Ph.D., Bioethicist in the Department of Bioethics in the Clinical Center at the National Institutes of Health and Neuroethics Consultant in the Neuroethics Program at the National Institute of Neurological Disorders and Stroke

Abstract: Developing new therapeutic devices may reduce the high burden of neurological and psychiatric disorders. In trials in which participants benefit from the device, or explantation is risky, device-related care for participants after the trial ends is a major ethical and practical challenge. Most patients who benefit from the device want to keep it. However, they may need among others, follow-up visits, replacement hardware, and software updates to maintain their benefits and reduce risks. Most posttrial needs are currently inconsistently met, which can lead to major consequences for patients. In some cases, patients have been left with a defunct implant. While some guidance exists for pharmaceuticals, specific guidance or best practices for device trials are lacking. Do researchers, funders, and industry-partners have responsibilities to facilitate posttrial care for reserach participants?