Study on subjects′ preferred intention and influencing factors of electronic informed consent in clinical research
10.3760/cma.j.cn113565-20231012-00084
- VernacularTitle:临床研究中电子知情同意受试者首选意愿及影响因素研究
- Author:
Xu ZUO
1
;
Yingshuo HUANG
1
;
Yue LI
1
;
Lihan XING
1
;
Shuilong GUO
1
Author Information
1. 首都医科大学附属北京友谊医院科技处，北京 100050
- Publication Type:Journal Article
- Keywords:
Clinical research;
Electronic informed consent;
Subject reference;
Influencing factors
- From:
Chinese Journal of Medical Science Research Management
2024;37(6):507-513
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This study aims to investigate the willingness of subjects to use electronic informed consent and analyze its influencing factors, so as to provide theoretical basis for the promotion of electronic informed consent.Methods:Questionnaires were designed and distributed to subjects through clinical research coordinator. Univariate and multivariate analysis were used to analyze the influencing factors of subjects′ preferred electronic informed consent.Results:All the subjects who had used e-informed consent had a positive evaluation on their overall satisfaction. 57.48% of subjects preferred electronic informed consent. The results of multi-factor analysis showed that age, the degree of concern about privacy disclosure and the electronic form were the 3 influencing factors.Conclusions:Electronic informed consent should be fully informed of the content, the language should be easy to understand, and the subject should be given a fair choice and a voluntary decision. The subject′s privacy must be protected in accordance with laws and regulations during the informed process. We should enhance the preferred willingness of subject to electronic informed consent through the above measures.The future development of electronic informed consent still needs the support of relevant policies, the continuous improvement of technical equipment and the supervision of relevant departments.
