Kim Scott Y H
Department of Psychiatry, Bioethics Program, and Program for Improving Health Care Decisions, University of Michigan Medical School, Ann Arbor, Michigan 48109, USA.
NeuroRx. 2004 Jul;1(3):372-7. doi: 10.1602/neurorx.1.3.372.
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.
美国生物伦理学在历史上起源于神学和哲学，一直以规范分析方法为主导。然而，作为政策的伦理学还需要坚实的证据基础。本文讨论了使神经治疗学研究特别具有挑战性的背景条件。在基于证据的伦理学框架内讨论了三个关键伦理问题：学术研究人员及其机构的经济激励结构变化所带来的伦理挑战、测试创新干预措施的神经治疗学方案的风险效益分析挑战，以及围绕研究中决策能力受损和替代同意的不断演变的问题。针对这些问题中的每一个，都回顾了选定的实证数据，指出了进一步探究的领域，并讨论了开发生物伦理学政策研究新方法的必要性。
