摘要
药物上市前须经过人体试验,参与药物临床试验的受试者将承担不同程度的风险,我国GCP明确规定要充分保障受试者的权益,伦理委员会和知情同意书是保障受试者权益的主要措施,但在实际中仍存在不少问题。为此,如何切实保障受试者的权益,是临床试验所要解决的一个重要问题。
Clinical trial should be completed before a new drug goes on the market. Human subjects should run a risk in clinical trial. In Good Clinical Trial（GCP）of China, there are some articles concerning the protection of human subjects. Ethics Committee and Informed Consent Form are two major measures. However,there are still many problems in the protection of subjects, rights and benefits. So, how to protect human subjects is an important issue in clinical trials.
出处
《华西医学》
CAS
2009年第2期342-343,共2页
West China Medical Journal
关键词
受试者权益
临床试验
伦理委员会
知情同意书
subjects,rights and benefits
clinical trial
ethics committee
informed consent form
