“When these studies are over, they’re not over": continuing trial responsibilities for implantable neural device trials
Saturday, October 14, 2023
10:30 AM – 11:45 AM ET
Location: Galena (Fourth Floor)
Developing new therapeutic devices may reduce the high burden of neurological and psychiatric disorders. Implanted neural device trials, because of their potential risks, generally recruit treatment-resistant participants with severe disease. In trials in which participants benefit from the device, device-related care for participants after the trial ends is a major ethical and practical challenge. Based on an NIH workshop including patients and professional stakeholders, literature review, and normative analysis, we identified unmet posttrial needs and considered the extent to which professionals involved in trials have a responsibility to facilitate them. Most patients who benefit from a device want to keep it, however, maintaining the benefits and reducing risks requires, among others, follow-up visits, replacement hardware, and software updates. Insurance coverage for experimental devices is uncertain and sometimes unlikely, and in the absence of specific guidelines or best practices, there is heterogeneity in the extent to which current trials plan for posttrial care. This can have major impacts on patients, in some cases, they have been left with a defunct implant. While other types of trials involve posttrial needs, several factors coalesce in implanted neural device trials which increase the weight of the normative foundations for posttrial responsibilities – beneficence and non-maleficence, reciprocity, respect for persons, and the partial-entrustment model. We therefore argue that professional stakeholders involved in these trials have a responsibility to further minimize gaps in important posttrial care. We propose the extent to which different posttrial needs should be covered and suggest a range of potential practical strategies.
Nina Hsu – OD – NINDS; Andrea Beckel-Mitchener – BRAIN Initiative – NIMH; John Ngai – BRAIN Initiative – NINDS; Christine Grady – Bioethics – NIH CC