某医院临床试验伦理委员会运行中的问题及解决对策

The Operation and Problem and Countermeasure of the Hospital Ethics Committees in Clinical Trials

某医院临床试验伦理委员会的人员组成与机构组成、运行基本符合国家相关要求。但在其建设运行中存在如下问题:委员构成不尽合理,对委员的培训滞后,审查的重点不明确,审查后的持续跟踪审查不到位,缺乏有效的监督机制。对此,提出如下对策:合理组织委员会委员,加强对伦理委员的培训,强化伦理跟踪审查,强化上级主管部门的监管。

The composition, construction and operation of clinical trials ethics committee in a hospital basically conform to relevant national requirements. But there are some problems as follows： the committee structure is unreasonable, the training of members is lag, the focus of the review is not clear, follow up review after review is not good, lack of effective supervision mechanism and so forth. To this point, this paper put forward the following countermeasures ： making organization reasonable, strengthen the training of ethics committee, strengthen the follow up review and strengthen supervision.