What does a participant agree to when an implant is designed to stay in the body? · Grey Matter
A stent electrode is incorporated into the wall of the vein over the following weeks, as vascular stents are, so it is meant to remain for life even if the study ends or the device stops being used.
What does a participant agree to when an implant is designed to stay in the body?
A stent electrode is incorporated into the wall of the vein over the following weeks, as vascular stents are, so it is meant to remain for life even if the study ends or the device stops being used. Consent therefore covers more than the procedure: living with an inactive implant, the chest unit and its lead, and the question of who will support the hardware years later. Reviews of neural device trials ask for these post-trial plans to be agreed before implantation, because the participant bears the consequences long after the research is published.