药物临床试验伦理委员会运作实践

The Operation of Ethics Committees in Drug Clinical Trials

在药物临床试验的过程中,必须对受试者的个人权益给予充分的保障,并确保试验的科学性和可靠性。伦理委员会与知情同意书是保障受试者权益的主要措施。为确保临床试验中受试者的权益,须成立独立的伦理委员会,并向国家食品药品监督管理局备案。介绍了某医院药物临床试验伦理委员会的组成及备案、规范伦理委员会运作、存在的问题以及解决的对策与方法。

In the process of drug clinical trials, it is necessary to give full guarantee of personal rights of the subjects, and ensure the scientific nature and reliability of the test. Ethics committee and informed consent are the main measures to safeguard the rights and interests of the subjects. In order to protect the clinical trial subjects＂ rights and interests, it should set up an independent ethics committee, and put on records in the State Food and Drug Administration. In this paper, the authors also introduced the construction and records, standard business, existing problems and solving countermeasures in a hospital ethics committee.