Analysis on the Current Status and Ethics Review Key Points of Electronic Informed Consent
10.12026/j.issn.1001-8565.2022.02.11
- VernacularTitle:电子知情同意的发展现状与伦理审查要点分析
- Author:
Wenli QIAO
1
;
Sijie WANG
1
;
Xinqing ZHAO
1
;
Xuening LI
1
;
Mengjie YANG
1
Author Information
1. Ethics Committee, Zhongshan Hospital Affiliated to Fudan University, Shanghai 200032, China
- Publication Type:Journal Article
- Keywords:
Electronic Informed Consent (E-Consent);
Ethical Review;
Clinical Study;
Welfare of Subjects
- From:
Chinese Medical Ethics
2022;35(2):175-179
- CountryChina
- Language:Chinese
-
Abstract:
Informed consent is one of the key elements to protect the rights and welfare of the patients or research subjects. With the development of electronic information technology, the diversity and convenience brought by the electronization makes the electronic informed consent (E-Consent) come into being. European and American countries have begun to apply E-Consent in the field of clinical trials, established a relatively perfect E-Consent platform and software system, and initially formed the guiding principles and recommendations of E-Consent. However, the implementation of E-Consent is still less in China, and there is no targeted legal basis and guidelines for ethical review. Therefore, this paper explored the implementation potential of E-Consent domestically by analyzing the application scenarios, advantages and disadvantages, and feasibility of E-Consent, and tried to establish the practical ethic review points of E-Consent based on the basic principles of ethical principles, to ensure that clinical trials have an appropriate E-Consent process.
