Draft NIH Resources to Support Implantable Device Trials
National Institutes of Health (NIH)
About this opportunity
Clinical trials involving implanted investigational medical devices ("implant trials") present unique ethical considerations that extend beyond the typical duration of research studies. Investigational implantable devices are increasingly used to treat various medical conditions (e.g., the use of deep brain stimulation devices for neurological disorders) but differ from other clinical trials in that devices may either remain in the body after trial completion or require surgical removal, with both scenarios carrying additional risks and potential costs. Participants may face ongoing care needs including device maintenance (battery replacements, software updates, adjustments), repair of malfunctioning components, monitoring to mitigate complications such as infection, and potential explanta...