Exploring knowledge and attitudes toward electronic informed consent among clinical trial participants in China: a cross-sectional study

Abstract

Background

With the extensive integration of digital technology into clinical research, intelligence, virtualization, and decentralization have gradually transformed into emerging clinical research modes, the electronization of informed consent has become indispensable to the development of clinical trial informatization, and the inclination to use electronic informed consent (eIC) has grown. The knowledge and perceptions of research participants, as objects of informed consent acquisition, regarding eIC are crucial. However, few studies have empirically explored such issues.

Methods

This cross-sectional study was conducted at three general hospitals in south-central China from July to September 2022. An online survey questionnaire was adapted and administered via WeChat to investigate the issues of interest.

Results

A total of 388 valid questionnaires were included in the analysis. The results showed that the overall response rate for the knowledge section of the questionnaire exceeded 70%. Of the respondents, 53.1% had heard of the term “electronic informed consent,” but only 43.2% had used eIC. The majority of respondents (68%) expressed a preference for using eIC and demonstrated a positive attitude toward it. However, some participants expressed concerns regarding the security and confidentiality (64.4%), operational complexity (52.3%), and effectiveness of online interaction (59.3%) in eIC. Statistically significant relationships were observed between participants’ attitude scores and their age, gender, type of participation, and frequency of involvement in clinical research. Additionally, a positive and statistically significant correlation was found between participants’ knowledge scores and their attitude scores.

Conclusion

The results of this study indicate that most participants have a good understanding of eIC-related knowledge and hold a positive attitude toward its implementation. However, they also express concerns about data protection and privacy security in eIC. These findings provide a foundation for developing targeted strategies to enhance the adoption and acceptance of eIC among diverse populations.