Psychometric evaluation of the Informed Consent Process Scale in Chinese.

Abstract

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. This study aimed to develop and psychometrically test the Chinese version of the Informed Consent Process Scale. 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. We recruited a total of 375 participants who had experience in signing an informed consent form within the previous 3 years in Taiwan. This study was approved by two Institutional Review Boards and the autonomy of the participants was respected. The Chinese version of the Informed Consent Process Scale is composed of three factors with 23 items showing evidence of acceptable reliability and validity. Three major factors were extracted and labeled: Factor 1 - 'Understanding of the research', Factor 2 - 'Trust and confidence' and Factor 3 - 'Doubt and uncertainty'. The three factors accounted for is 52.954 of the total variance with Cronbach's α of .917. The finding corroborates previous studies showing that participants had too little understanding on the informed consent forms they signed and implied the need to clarify the critical points in clinical research. The psychometric results indicated good internal consistency and validity for this newly constructed instrument, and it was found worthy of conducting further testing and application.