Legal Points in Ethical Review of Subjects’ Informed Consent
10.12026/j.issn.1001-8565.2022.11.04
- VernacularTitle:受试者知情同意伦理审查中的法律要点
- Author:
Xuanlin LIU
1
Author Information
1. Medical Security Law and Policy Research Center, China University of Political Science and Law, Beijing 100088, China
- Publication Type:Journal Article
- Keywords:
Biomedical Research;
Subjects;
Informed Consent;
Ethical Review;
Protection of Rights and Interests
- From:
Chinese Medical Ethics
2022;35(11):1188-1195
- CountryChina
- Language:Chinese
-
Abstract:
Subjects’ informed consent are needed in biomedical research, which has been confirmed by the Civil Code of the People’s Republic of China, Law of the People’s Republic of China on the Promotion of Basic Medical and Health Care, and Law on Doctors of the People’s Republic of China. Due to the professionalism and complexity of the law, researchers often have deficiencies in the use of legal terms, the fulfillment of disclosure obligations and the protection of subjects’ rights and interests when writing informed consent forms. When the ethics committee conducts ethical review on the informed consent form of the subjects, there are some problems such as lack of objective ability or insufficient subjective attention to the above shortcomings of the researchers. By combing the legal points, this paper summarized the correction scheme to provide reference for ethical review.
