摘要
目的通过伦理委员会、机构及研究者三个方面对药物临床试验中弱势群体的保护问题进行探讨,寻找更好的出路和方法来保护弱势群体的安全和权益。方法根据相关文献及医院实际情况,综合分析弱势群体的安全问题。结果只有伦理委员会、机构及研究者三方共同协力合作,才能最大程度保障弱势群体的安全和权益。结论深入研究弱势群体的安全问题不仅促进人类健康事业发展,而且对于完善药物临床试验中受试者保护问题起到决定性作用。
Objective：To find a better way to protect the security and interests of vulnerable groups by explo- ring the problem of protecting the vulnerable groups in drug clinical trial from the perspectives of ethics committees, organization and researchers. Methods ： According to the relevant literature and the actual situation of the hospital, this paper analyzed the security issues of vulnerable groups comprehensively. Results： Only the ethics committees, organization and researchers work together, can it protect the security and interests of vulnerable groups to the grea- test extents. Conclusion ： Further research on the security of vulnerable groups not only promotes the development of human health, but also plays a decisive role in improving the protection of subjects in drug clinical trial.
出处
《中国医学伦理学》
2017年第5期572-575,共4页
Chinese Medical Ethics
关键词
药物临床试验
弱势群体
伦理委员会
受试者
Drug Clinical Trial
Vulnerable Groups
Ethics Committee
The Subjects
