Challenges to deep brain stimulation: a pragmatic response to ethical, fiscal, and regulatory concerns.

Abstract

In response to the early success of deep brain stimulation, we offer some common-sense strategies to sustain the work, addressing the need to do so in a fiscally workable, ethically transparent, and scientifically informed manner. After delineating major threats, we will suggest reforms in both the legislative and regulatory spheres that might remediate these challenges. We will recommend (1) revisions to the Bayh-Dole Act of 1980, which governs intellectual property exchange resulting from federally funded research; (2) revisions to the Association of American Medical Colleges recommendations concerning the management of conflicts of interest when scientists with an intellectual property interest participate in clinical research in tandem; (3) revisions to the Food and Drug Administration's pre-market approval process for new devices, including a proposal for a mini-investigational device exemption; and (4) the establishment of a public-private partnership to build ethical and sustainable synergies between the scientific community, industry, and government that would foster discovery and innovation.