Legal Points in Ethical Review of Subjects’ Informed Consent / 中国医学伦理学

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.