Psychometric evaluation of the Informed Consent Process Scale in Chinese

Background:Informed consent is essential for the ethical conduct of clinical research and is a culturally sensitive issue. But, a measurable Chinese version of the scale to evaluate the informed consent process has not yet been explored in the existing literature.Research objectives:This study aimed to develop and psychometrically test the Chinese version of the Informed Consent Process Scale.Research design:Back-translation was conducted to develop the Chinese version of the questionnaire. A cross-sectional survey was administered, after which an exploratory factor analysis was conducted.Participants:We recruited a total of 375 participants who had experience in signing an informed consent form within the previous 3 years in Taiwan.Ethical considerations:This study was approved by two Institutional Review Boards and the autonomy of the participants was respected.Findings:The Chinese version of the Informed Consent Process Scale is composed of three factors with 23 items showing evidence of acceptable rel...