To Explant or not to Explant Neural Implants: an Empirical Study into Deliberations of Dutch Research Ethics Committees.

Abstract

Neural implants such as brain-computer interfaces and spinal cord stimulation offer therapeutic prospects for people with neurological and psychiatric disorders. As neural devices are increasingly tested in clinical research, the decision to explant requires carefully weighing both known and unknown medical and psychological risks, necessitating a thorough evaluation of the benefits and risks of each available option. Research Ethics Committees (RECs) play an important role in assessing research protocols and determining the conditions under which neural implants should be explanted, yet little is understood about how RECs make these decisions. To better understand the role of RECs in explantation decisions of neural implants, we approached REC secretaries within the Netherlands via email, with a list of open-ended questions of which the explantation of neural devices, on informed consent and post-trial care and responsibilities, and psychological harm associated with such trials. The findings highlight the differential technology-specific safety assessments conducted for different types of neural devices. Variability was observed in plans regarding clinical follow-up, post-trial access, and explantation options. While RECs emphasized clear participant information on device maintenance and longevity, the timing of this disclosure varied. Additionally, the psychological impact of explantation was rarely addressed in REC assessments, indicating a gap in ethical oversight. These results shed light on some remaining gaps and suggest the need for improvement in achieving more consistent and comprehensive evaluations of neural device clinical trials, particularly regarding explantation and post-trial access.

Supplementary information: The online version contains supplementary material available at 10.1007/s12152-025-09619-z.