| In a drug clinical trial,experimental legal nexuses were formed among the human subjects,the investigator,Ethics Committee and the sponsor of the drug clinical trial.As the human subject is taking a bigger risk in the drug clinical trial than in the ordinary medical treatment,the human subject's rights and interests must be fully protected.In medical research on human subjects,considerations related to the well-being of the human subject should take precedence over the interests of science and society.In order to protect the rights and interests of human subjects,an independent Ethics Committee shall be formed and the protocol of the trial may not be implemented without approval from the Ethics Committee.It's important to protect the human subjects' right of informed consent as the subjects must be volunteers and informed participants in the research project. Ethics Committee have an obligation to protect the human subjects' right of informed consent against the individual subject and so the investigator and the sponsor of the drug clinical trial.The paper is an analysis of Li Tong-bin v.Nantong Hospital and Xinglong Pharmaceutical Co.,Ltd.There're 3 parts in this article:The first part is an overview of the case.The second part has described the human subjects' right of informed consent,the important methods to protect the human subjects' right of informed consent and the Causal relationship in the drug clinical trial.This section focuses on the content of the human subjects' right of informed consent and the methods to protect it.Informed consent is not only signed a consent form,it should be a process that the investigator or its designated representative explain the rights and obligations to human subjects in detail in order that the agreement to participate is based on a good understanding of the trial.Informed consent form should be written format.Ethics Committee and informed consent form are important methods to protect the human subject.The investigator should also be supervised by Ethics Committee and the sponsor throughout the clinical trial process. The third part is a conclusion.Based on the evidence submitted by the parties and the research of the relevant legal theories,the following conclusions can be drawn:1,Nantong Hospital and Xinglong Pharmaceutical Co.,Ltd. Should not be held responsible for all the consequences of the plaintiff's right of informed consent violated by the informed consent form that lack of content.2, Neither the investigator nor the sponsor had performed the proper obligations to protect the human subject's rights and interests during the drug clinical trial.3,The plaintiff had suffered physical injuries because of participation in the drug trial. |
