An Ethical Evaluation Index System for Clinical Approval of Medical Technology in China： A Structural Equation Model Study

Objective： To construct a quantitative ethical evaluation index system for the clinical approval of medical technology in China. Methods： Exploratory factor analysis （EFA） and first-order confirmatory factor analysis （CFA） based on a structure equation model （SEM）, higher-order CFA and normalisation were used to establish an ethical evaluation index system for the clinical approval of medical technology. Data were processed in SPSS 13.0 and Lisre 15.3. Results： There were 52 third class indices, 15 second class indices, and 3 first class indices in this ethical evaluation index system. The weight of each index was calculated by normalisation. Conclusion： This study developed a three-level ethical evaluation index system, comprising 70 indices, for the clinical approval of medical technology.