Workgroups: Ethics, Neural Data Privacy, and Data Security; Public Messaging, BCI Education, & Regulatory Science Education that Could Support Policy
Date Updated: 23 May 2026
Overview:
This project develops an iBCI-CC response to NIH’s Request for Information on two draft resources intended to support clinical trials involving investigational implantable devices.
The first resource addresses planning for post-trial needs of participants who receive investigational implantable devices. The response discusses post-trial care obligations, device retention and explantation, continuity of technical and clinical support, cybersecurity, oversight, and feasible funding mechanisms.
The second resource addresses informed consent for research using investigational implantable devices. The response recommends clearer guidance on ongoing consent, research participation demands, device deactivation, risks and benefits, data handling, withdrawal, and post-trial support.
Audience and Application:
National Institutes of Health (NIH). Intended for submission in response to NIH’s request for public feedback on the two draft resources, with particular attention to considerations relevant to implantable brain-computer interface research.
