【摘要】 目的 分析疫苗临床试验项目伦理初始审查出现的问题，为规范疫苗临床试验方案设计和知情同意书等的制订，研究项目的开展以及为伦理审查提供借鉴。方法 选择某疾病预防控制中心医学伦理委员会2017-2021年期间受理审查的疫苗临床试验项目，采用现场资料调查法，统计5年内受理审查的项目，描述分析初始审查通过率及通过方式，以及研究方案、招募告知书、知情同意书等伦理审查时存在的常见问题。结果 2017-2021年共审查60项疫苗临床试验项目，其中，初始审查一次性通过率为3.33%,96.67%的项目审查意见均为做必要修正后同意。修改意见中方案修改所占比重最高（60.13%），主要问题集中于与研究目的有关的研究设计（15.69%）、入排标准（12.42%）和试验背景介绍（11.76%）。知情同意书中出现较频繁的问题包括风险考虑（10.46%）、治疗与补偿（9.15%）和语言表达（7.19%）。结论 疫苗临床试验项目初始审查一次性通过率不高，规范性欠佳、问题涉及方面较多。伦理审查对规范方案设计、保护受试者安全和权益、提高项目质量具有重要作用。更多还原

【Abstract】 Objective To analyze issues arising from the initial ethical review of vaccine clinical trial projects for standardizing the design of vaccine clinical trial protocols and informed consent forms, carrying out research projects and providing references to the ethical review. Methods The vaccine clinical trial projects accepted for review by the Medical Ethics Committee of a center for disease control and prevention from 2017 to 2021 were selected. The on-site data survey method was used to count the number of projects accepted for review within 5 years and the number of projects that have passed the initial review at one time,and the common problems in the ethical review process were analyzed in depth. Results From 2017 to 2021, a total of 60 vaccine clinical trial projects were reviewed, of which the one-time pass rate of the initial review was 3.33%, and the review comments for 96.67% of the projects were that it would be approved after necessary modifications. The proportion of protocol modifications in the modification opinions was highest(60.13%), with the main issues focused on research design related to the research purpose(15.69%), inclusion criteria(12.42%), and experimental background introduction(11.76%). Frequent issues in informed consent forms included risk considerations(10.46%), treatment and compensation(9.15%), and language expression(7.19%).Conclusions The initial review of vaccine clinical trial projects has a low one-time approval rate, with poor standardisation and more problematic aspects.The ethical review plays an important role in standardizing of protocol design, protecting the safety and rights of subjects, and improving project quality.更多还原