Evidence-Based Ethics for Neurology and Psychiatry Research
Scott Y. H. Kim
Department of Psychiatry, Bioethics Program, and Program for Improving Health Care Decisions, University of Michigan Medical School, Ann Arbor, Michigan 48109
Address correspondence and reprint requests to Dr. Kim, Bioethics Program, University of Michigan Medical School, 300 North Ingalls Street, Room 7D, Ann Arbor, MI 48109-0429. E-mail: [email protected]
Summary: American bioethics, historically arising out of theology and philosophy, has been dominated by the method of normative analysis. Ethics as policy, however, requires in addition a solid evidence base. This paper discusses the background conditions that make neurotherapeutics research particularly challenging. Three key ethical issues are discussed within an evidence-based ethics framework: the ethical challenges arising from changes in the financial incentive structures for academic researchers and their institutions, the challenges of risk-benefit analysis for neurotherapeutics protocols testing innovative interventions, and the evolving issues surrounding impaired decision-making capacity and surrogate consent for research. For each of these issues, selected empirical data are reviewed, areas for further inquiry are noted, and the need for development of novel methods for bioethics policy research is discussed.
Keywords: Research ethics, conflicts of interest, informed consent, risk-benefit analysis, neurotherapeutics
NeuroRx. 2004 July; 1(3): 372–377.