知情同意书可理解性与可读性的问卷调查:以一项IgA肾病临床研究 为例

A questionnaire-based study on comprehensibility and readability of informed consent forms: a case study of a clinical trial on IgA nephropathy

  • 摘要: 背景 知情同意书是保护研究参与者权益的核心文件,由于专业性强、术语多,可能对研究参与者理解和签署带 来一定困难。目的 本研究以IgA肾病临床研究为例,初步探究临床研究知情同意书的可理解性和可读性。方法 本研究 选取一项CAR-T细胞治疗进展期IgA肾病的临床研究知情同意书作为阅读材料,针对基本信息、信息掌握度、自我感知 度、态度与接受度4个维度共设计44项问卷条目。在门诊和病房对IgA肾病患者进行问卷调查,调查对象在阅读知情同意 书材料后填写问卷。结果 本研究共收集68份有效调查问卷。调查发现,仅有24名(35.29%)调查对象认为本知情同意书材 料容易阅读,33名(48.53%)认为自己无法在独立阅读的情况下完全理解知情同意书内容。调查对象对治疗方法(18名, 26.47%)、个人资料使用(22名,32.35%)、生物样本采集(29名,42.65%)等权利和自主性的内容认识不足。结论 本研究初 步揭示了知情同意书设计的系统性不足,提示需进一步优化知情同意书撰写的可理解性和可读性,为今后临床研究伦理实 践提供借鉴。

     

    Abstract: Background The informed consent form (ICF) is is a core document for protecting the rights and interests of research participants. However, due to its high level of professionalism and the use of many technical terms, it may create difficulties for participants in understanding and signing.Objective To preliminarily explore the comprehensibility and readability of ICFs by using a clinical trial on IgA nephropathy as an example.Methods The ICF from a clinical trial on CAR-T cell therapy for advanced IgA nephropathy were selected as the reading material. A total of 44 questionnaire items were designed across four dimensions: basic information, level of information comprehension, self-perceived understanding, and attitudes and acceptance. Questionnaires were administered to IgA nephropathy patients in outpatient clinics and hospital wards. Participants completed the questionnaires after reading the informed consent materials. Results A total of 68 valid questionnaires were collected in this study. Among the participants, only 24 (35.29%) considered the ICF easy to read, while 33 (48.53%) reported that they could not fully understand the content when reading independently. Insufficient awareness was observed in areas related to treatment methods (18 participants, 26.47%), use of personal data (22 participants, 32.35%), and biological sample collection (29 participants, 42.65%).Conclusion  This study preliminarily reveals systemic deficiencies in the design of ICFs, highlighting the need to further optimize the comprehensibility and readability of informed consent document writing, thereby providing valuable insights for future ethical practices in clinical research.

     

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