Discussion on standardizing informed consent to improve the quality of clinical trials
临床试验伊始受试者风险识别及保护机制的探讨

摘要

目的 为了更好的保护受试者的安全和权益，在临床试验伊始就控制好受试者的风险因素，从源头上解决受试者保护问题。方法 分析临床试验伊始影响受试者权益和安全的风险因素，提出相应的受试者风险管理措施。结果 临床试验伊始受试者安全风险因素主要集中在知情同意书和临床试验方案上，通过临床试验各方的共同努力，建立风险管理措施，有效降低受试者的安全风险。结论 受试者的安全和权益贯穿整个临床试验，为了更好的保护受试者，在临床试验伊始就充分发掘和识别受试者安全风险因素，有效落实受试者保护机制。

Abstract

Objective: In order to better protect the safety and rights of subjects, the risk factors of vulnerable subjects should be controlled at the beginning of clinical trials to solve the problem of subject protection from the source.
Methods: To analyze the risk factors that affect the safety of subjects at the beginning of clinical trials, and put forward the risk management measures for subjects.
Results: At the beginning of clinical trials, the safety risk factors of subjects mainly focus on informed consent and clinical trial scheme, through the joint efforts of all parties in clinical trial, risk management measures were established to effectively reduce the safety risk of subjects.
Conclusion  : The safety and rights of the subjects run through the whole clinical trial. In order to better protect the subjects, the safety risk factors of subjects should be fully explored and identified at the beginning of clinical trials, and the subject protection mechanism should be effectively implemented.