Informed Consent Forms Main Issues Review Points Good Clinical Practice for Drugs
2024年江苏省医院协会医院管理创新研究课题（JSYGY-2-2024-47）；常州市卫健委青年项目（QN202352）
目的：分析我院药物临床试验知情同意书存在的主要问题并提出改善建议。方法：参考新版药物GCP和我院SOP，结合专家意见，明确我院知情同意书审查要点，对审查决定中关于知情同意书的修改意见进行分类汇总，并通过帕累托分析找出主要问题。结果：知情同意书存在问题的项目有110项，占82.1%；主要集中在语言表述、试验内容模糊、权益风险和费用补偿告知。结论：应加强对伦理委员会秘书、委员、研究者伦理相关的继续教育和培训，加强伦理委员会的监督职能，提供符合法规和我院SOP要求的知情同意书撰写要点，保护受试者权益的同时提高伦理审查通过率。
Objective：Analyze the main issues of informed consent forms for clinical drug trials and propose improvement suggestions. Methods：Referring to the new version of drug GCP and our hospital SOP，combining with expert opinions，to clarify the key points for reviewing our hospital’s informed consent form. Then，classify and summarize the modification opinions on the informed consent form in the review decision，and determine the main issues through Pareto analysis. Results：There are 110 items with issues of informed consent forms，accounting for 82.1%. Mainly focus on language expression，vague experimental content，equity risks，and cost compensation disclosure. Conclusions：It is necessary to strengthen continuing education and training related to ethics for ethics committee secretaries，members，and researchers，strengthen the supervisory function of the ethics committee，and provide key points for writing informed consent forms that comply with regulations and our hospital’s SOP requirements. So that we can protect the rights and interests of subjects while increasing the pass rate of ethical review.