药物临床试验受试者权益保护的述评及策略探讨

Review and Discussion of Strategy on Clinical Trials Participants' Rights Protection

阐述了药物临床试验受试者权益保护的历史与发展的背景,全面介绍了受试者应享有的受尊重权、知情权、自主决定权、隐私权、补偿权、免费治疗权以及赔偿权等主要权益,并对其概念和特点进行了界定和诠释。进一步针对不同分期的药物临床试验的特点,分析受试者权益没有得到完善保护的方面。在已有的历史经验教训基础上,分析不同分期药物临床试验的受试者权益保护的薄弱环节,探讨受试者权益保护的改善策略,包括:加强教育培训及宣传;完善伦理审查管理机制;建立风险保障机制。

This article has reviewed history and development of participants＇ fights protection, elaborated on deiimtlon and characteristics of participants＇ rights including respect, information, autonomy, privacy, free medical treatment, com- pensation and other main fights, analyzed the weakness of participants＇ fights protection in consideration of different stages of clinical trials and explored strategies of participants rights protection, including： strengthening education training and publicity; improving the management of ethical review mechanism; establishing risk security mechanism.