Physicians must ensure that patients understand that the principal aim of research is to increase generalizable knowledge. However, patients may hope for individual benefit as a secondary goal of participation. Highly motivated patients may request treatment off label if trial enrollment has ended, leading to ethical dilemmas for clinicians. This case uses early deep brain stimulation (DBS) as an example for exploring the ethically relevant questions related to the off-label use of medical devices.
Address correspondence to Dr David Charles, Department of Neurology, 1161 21st Avenue South, Suite A-1106 Medical Center North, Nashville, TN 37232-2551, firstname.lastname@example.org.
Relationship Disclosure: Dr Fleming reports no disclosure. Vanderbilt University receives income from grants and contracts with Allergan, Ipsen, Medtronic, and Merz for research and educational programs led by Dr Charles. Dr Charles receives income from Allergan, Ipsen, Medtronic, and Merz for consulting services. Dr Charles has received income from the Davis Phinney Foundation and from serving as an expert witness.
Unlabeled Use of Products/Investigational Use Disclosure: Drs Fleming and Charles discuss the unlabeled use of deep brain stimulation in the early disease course of Parkinson disease.