Comparative analysis of multiple models of electronic informed consent in clinical research
10.3760/cma.j.cn113565-20230109-00004
- VernacularTitle:临床研究中多种电子知情同意模式比较分析
- Author:
Xu ZUO
1
;
Yue LI
;
Yingshuo HUANG
Author Information
1. 首都医科大学附属北京友谊医院科技处 100050
- Keywords:
Clinical research;
Electronic informed consent;
Comparative analysis
- From:
Chinese Journal of Medical Science Research Management
2023;36(3):194-199
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To provide decision-making support for electronic informed consent selection and promotion in clinical research, and lay a possible theoretical foundation for better protection of subjects′ rights and interests, as well as promotion of clinical research quality and efficiency.Methods:This paper summarized the relevant laws and regulations of electronic informed consent, analyzed the advantages and challenges of the application of electronic informed consent in clinical research, sorted out several common electronic informed consent modes in domestic clinical research, explored their operational processes and applications, and discussed their advantages and limitations.Results:At present, three electronic informed consent modes were mainly used in domestic clinical studies. Each had their own advantages and limitations in terms of convenience of operation, data security, privacy protection of subjects, cost input, popularization degree and so on.Conclusions:Electronic informed consent needs continuing improvement of relevant laws and regulations and the joint efforts of all stakeholders engaged in clinical research. The sponsor and the researcher should take full consideration of the cost, safety, security, feasibility, and ofters, and make the selection according to the actual needs of the research.
