DBS and the Ethical Mandate To Foster Trust and Sustain Scientific Advances

The legacy of the psychosurgery era and the potential vulnerabilities of individuals with neuropsychiatric disorders create an ethical mandate to promote and sustain public trust in deep brain stimulation (DBS). Trust as a precondition for scientific advance will be explored in the context of clinical practice, translational research, device development and regulatory oversight. At the level of clinical practice and medical research, factors which might compromise the integrity of the informed consent process for patients deciding to receive DBS as therapy (or subjects considering participation in a clinical trial) include: the impact of decisional capacity on patient/subjects choices; the fostering of a therapeutic misconception in research settings for investigational devices; and physician/investigator conflict of interest. Corporate strategies for device development, interaction with the medical community, and product dissemination will also be considered for their ability to create markets, foster innovation and sustain public confidence in DBS and neuromodulation. Chief amongst these factors will be a consideration of the role that the Bayh-Dole Act has on the exchange of intellectual property (IP) rights and the conduct of research, open inquiry and the scientific commons. Regulatory challenges will also be assessed, including: institutional management of investigator conflicts of interest; the growing regulatory lacunae between academic and corporate governance; and how new devices are assessed by government agencies, such as the Food and Drug Administration (FDA). Of specific concern will be the FDA’s  definition of device “equivalence” and how devices are categorized as investigational or humanitarian and the ethical import of such designations. In the aggregate these challenges to the public trust create opportunities to reform current practices, promote transparency and articulate the ethical principles and practices that can support the scientific advancement of this promising technology.