Purpose: The current study aimed to develop and psychometrically test the Chinese version of the Informed Consent Process Scale (ICPS-CV).
Methods: 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.The criteria included in the study were the following: (a)the participants had experience of having signed a research ICF within the previous 3 years, (b) their age was over 20, and, (c) they were able to communicate in Chinese. Exclusion criteria were (a) inability to independently consent, and (b) inability to read or sign the study’s ICF. In order to keep the heterogeneity high, we tried to reach institutions in three different regions (north, middle, and south) of Taiwan. This study was approved by two Institutional Review Boards, and the autonomy of the participants was respected.
Results: The ICPS-CV is composed of 3 factors with 23 items. Three factors extracted through EFA, including ‘Understanding of the research’, ‘Trust and confidence’, and ‘Doubt and uncertainty’, explained 52.954 % of total variance. Cronbach’s αcoefficients of the ICPS-CV total scale was .917, and of three subscales were .925, .865, and .713, respectively.
Conclusion: The ICPS-CV is composed of 3 factors with 23 items. Three factors extracted through EFA, including ‘Understanding of the research’, ‘Trust and confidence’, and ‘Doubt and uncertainty’, explained 52.954 % of total variance. Cronbach’s αcoefficients of the ICPS-CV total scale was .917, and of three subscales were .925, .865, and .713, respectively. These findings corroborate previous studies showing participants had too little understanding on the Informed Consent Forms they signs. Our study indicated good internal consistency for this Chinese version instrument. The results were found worthy of further testing and application.