Risk and consent in neuropsychiatric deep brain stimulation: An exemplary analysis of treatment-resistant depression, obsessive-compulsive disorder, and dementia

Abstract

Interest in deep brain stimulation (DBS) for treatment-refractory psychiatric disorders has raised ethical concerns about the adequacy of safeguards for human subjects. The nature of DBS and potential vulnerability of participants have raised worries about whether study participants have capacity to give informed consent (including understanding the risks associated with DBS and the likelihood of personal benefit), and can appropriately distinguish between DBS research and clinical care. Empirical inquiry into these concerns suggests that the vast majority of prospective participants under consideration for early trials of DBS for treatment-resistant depression (TRD) had adequate decisional capacity. While these patients considered DBS for various and often unique reasons, most understood the risks and had reasonable expectations of benefit. These results suggest that given appropriate procedures, patients with TRD can provide informed consent to DBS research. Further attention is needed to understand patients’ considerations for DBS research, and to evaluate procedures to enhance appreciation of distinctions between research and clinical contexts. Similar inquiry on DBS research for other psychiatric disorders is needed, particularly because greater cognitive impairment is associated with worse performance on measures of decisional capacity. Safeguards such as surrogate consent should be considered (and their use reported) when studies enroll patients with cognitive disorders, such as Alzheimer’s disease and other dementias. Research is needed into whether patients with obsessive-compulsive disorder are more likely than those with depression to lack adequate capacity.