摘要
在对涉及人体的临床试验进行伦理审查时,对受试者的保护是审查的主要目的和关注重点.本研究论述了审查过程中如何权衡受试者的权益、安全、健康与科学和社会利益之间的关系、如何审查知情同意书中的“伤害赔偿”条款以及与保险相关的条款、科学界定涉及弱势群体的人体生物医学试验项目、涉及弱势群体的试验项目如何进行伦理审查等目前比较敏感的问题.
The ethics review for clinical trials pertaining to human body highly emphasizes human subjects protection.This study discussed how to balance the relationship between the rights,safety and health of the subjects and interests of the science and the community,how to review the damage compensation provisions and insurance provisions in the informed consent,how to scientifically define the human subject biomedical trials involving vulnerable groups,and how to conduct trials on vulnerable groups,as well as other sensitive issues in ethics review.
出处
《中华医院管理杂志》
北大核心
2014年第12期919-921,共3页
Chinese Journal of Hospital Administration
关键词
受试者
保护
伦理
弱势群体
Human subjects
Protection
Ethics
Vulnerable groups
