也论药品临床试验的伦理要求

本文拟在业已公认的人体实验伦理原则基础上,结合现行GCP中的有关内容,提出了药品临床试验的伦理要求,指出了受试者的具体权益以及保护受试者权益的具体措施,特别强调,为确保临床试验中受试者的权益并为之提供公众保证,应成立临床试验的伦理委员会,伦理委员会的组成和工作应是独立的,不受任何参与试验者的影响,文中就伦理委员会的工作目的、组织形式以及对临床试验的审查要点等亦进行了介绍,相信这对管理者从伦理角度管理好药品临床试验将会有所帮助。

Views On the Ethical Reguirements of Making Clinical Experiments On Drugs

Based on the established ethical principles of Human Body Experiments, Combined it with the Current Contents of " Administrative Standards of Clinical Experimentson drugs (proposed standards)" ,the author makes the ethical demands, points outthe specific rights and interests and particular methods for the persons who receive the tests, Specially Stresses that in order to ensure the rights and interests of the persons and provide the public guarantees, a ethial committee of clinical experiments shoud be set up. The orgnization and work should be independent, not be influenced by any tester; furthernore the author introduces the work goal, orgnzation form , and main points of examination on clinical experi-ment etc. It will be helpful for the administrators to supervise the clinicalexperinents on drugs well from thepoint of ethical views.