title: An ethical evaluation index system for clinical approval of medical technology in China: A structural equation model study.
abstract: 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 l5.3.
  
  
  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.
  
  
  CONCLUSIONS
  This study developed a three-level ethical evaluation index system, comprising 70 indices, for the clinical approval of medical technology.
authors.affiliation: Collaborative Innovation Center of Network and Big Data Applications, Lingnan Normal University, Zhanjiang, Guangdong Province, 524048, China.
authors.forename: Jing-Xian
authors.initials: JX
authors.lastname: Li
authors.affiliation: Department of Finance, College of Economics, Jinan University, Guangzhou, 510632, China.
authors.forename: Zhi-Cheng
authors.initials: ZC
authors.lastname: Qiao
authors.affiliation: Department of Pediatric, Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong Province, 524001, China.
authors.forename: Hong-Xia
authors.initials: HX
authors.lastname: Ma
authors.affiliation: Teaching and Research Section of Health Care Management, School of Health Management and Education, Capital Medical University, Beijing, 100069, China.
authors.forename: Yi-Ting
authors.initials: YT
authors.lastname: Li
authors.affiliation: Chinese Journal of Medical Ethics, Xi'an Jiaotong University, Xi'an, 710061, China.
authors.forename: En-Chang
authors.initials: EC
authors.lastname: Li
authors.affiliation: Chinese Journal of Medical Ethics, Xi'an Jiaotong University, Xi'an, 710061, China.
authors.forename: Peng-Cheng
authors.initials: PC
authors.lastname: Ji
authors.affiliation: Collaborative Innovation Center of Network and Big Data Applications, Lingnan Normal University, Zhanjiang, Guangdong Province, 524048, China. huanggang6108@126.com.
authors.forename: Gang
authors.initials: G
authors.lastname: Huang
mesh_terms: D020811:Biomedical Technology / Q000941:ethics* / Q000331:legislation & jurisprudence*; D002681:China; D005163:Factor Analysis, Statistical; D006801:Humans
keywords: ethical review; factor analysis; medical technology; structural equation model