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Psychometric evaluation of the Informed Consent Process Scale in Chinese
Shu Yu Chen1, Shu-Chen Susan Chang1, Chiu-Chu Lin2
1Changhua Christian Hospital; School of Nursing, Dayeh University.
A new Chinese scale evaluates the informed consent process in clinical research, revealing participants often misunderstand study details. This tool is vital for improving ethical research practices and participant comprehension.
Area of Science:
- Clinical Research Ethics
- Psychometrics
- Health Sciences
Background:
- Informed consent is crucial for ethical clinical research but is culturally sensitive.
- A validated Chinese scale for evaluating the informed consent process was lacking.
- Cultural nuances in informed consent require culturally specific assessment tools.
Purpose of the Study:
- To develop and psychometrically test a Chinese version of the Informed Consent Process Scale.
- To provide a reliable and valid instrument for assessing informed consent in Chinese-speaking populations.
- To address the gap in culturally appropriate tools for evaluating informed consent.
Main Methods:
- Developed the Chinese version of the scale using back-translation.
- Conducted a cross-sectional survey with 375 participants in Taiwan.
- Performed exploratory factor analysis to determine scale structure and psychometric properties.
Main Results:
- The Chinese Informed Consent Process Scale has 23 items across three factors: 'Understanding of the research,' 'Trust and confidence,' and 'Doubt and uncertainty.'
- The scale demonstrated acceptable reliability (Cronbach's α = .917) and validity, explaining 52.954% of the variance.
- Factor analysis confirmed a robust structure for the Chinese version of the scale.
Conclusions:
- Findings suggest participants often have limited understanding of informed consent forms, highlighting the need for clearer communication.
- The developed Chinese scale is a reliable and valid instrument for assessing the informed consent process.
- The scale is suitable for further testing and application in clinical research settings to enhance participant understanding and ethical conduct.
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