Wendler D, Miller F G
Department of Clinical Bioethics, The NIH Clinical Center, National Institutes of Health, Bethesda, MD, USA.
J Med Ethics. 2007 Aug;33(8):481-6. doi: 10.1136/jme.2005.014043.
Dual-track assessment directs research ethics committees (RECs) to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.
双轨评估指导研究伦理委员会(RECs)基于治疗性干预和非治疗性干预之间不明确的区分来评估研究干预措施的风险。相比之下,净风险测试依赖于临床上常用的评估干预措施与现有替代方案相比的风险和益处的方法,并且还将伦理委员会的注意力集中在保护研究参与者这一核心挑战上。