某医院伦理委员会在临床试验开展中的职能、存在的问题与对策研究

The Function,Problems and Countermeasures for the Ethics Committee in the Ethical Review on Clinical Trial

某医院伦理委员会在项目审查中常发现以下问题:试验方案撰写不规范,知情同意书格式不规范、要素不全、语言描述过于专业化,申请伦理审查的时机滞后。对此,提出相应对策:加强研究者的医学伦理学教育、强化研究者对伦理审查的认识,加强伦理委员会内部的培训和继续教育,加强伦理委员会建设、制定和不断完善伦理委员会的标准操作规程和工作制度。

In this paper, the following problems of the ethical review in hospital ethics committee were put forward： protocol writing is not standard, the informed consent form is not standard, incomplete elements, language description is too professional, applying for ethical review is not in time. To this, the authors put forward the corresponding countermeasures： strengthening the medical ethics education, strengthening the awareness of ethical review, strengthening ethics committee internal training and continuing education, strengthening the construction of ethics committee, developing and constantly improving the system of ethics committee＇s standard and operating procedures.