Cody Robert J
Division of Cardiology, Department of Internal Medicine, University of Michigan Health System, Ann Arbor, Michigan 48109-0271, USA.
Cancer Invest. 2006 Mar;24(2):209-14. doi: 10.1080/07357900500524678.
Failure Mode and Effects Analysis (FMEA) is a method applied in various industries to anticipate and mitigate risk. This methodology can be more systematically applied to the protection of human subjects in research. The purpose of FMEA is simple: prevent problems before they occur. By applying FMEA process analysis to the elements of a specific research protocol, the failure severity, occurrence, and detection rates can be estimated for calculation of a "risk priority number" (RPN). Methods can then be identified to reduce the RPN to levels where the risk/benefit ratio favors human subject benefit, to a greater magnitude than existed in the pre-analysis risk profile. At the very least, the approach provides a checklist of issues that can be individualized for specific research protocols or human subject populations.
失效模式与效应分析（FMEA）是一种应用于各个行业以预测和降低风险的方法。这种方法可以更系统地应用于研究中对人类受试者的保护。FMEA的目的很简单：在问题发生之前预防问题。通过将FMEA过程分析应用于特定研究方案的各个要素，可以估计失效的严重程度、发生率和检测率，以计算“风险优先数”（RPN）。然后可以确定方法，将RPN降低到风险/收益比有利于人类受试者受益的水平，且受益程度要高于分析前的风险状况。至少，该方法提供了一份问题清单，可针对特定的研究方案或人类受试者群体进行个性化处理。
