解放军医学院学报2025，Vol.46Issue(10)：994-1002,1010,10.DOI:10.12435/j.issn.2095-5227.25061202
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
杨千粟 1刘帅 1张迪 2赵励彦 3曹江 1白楠1
作者信息
- 1. 解放军总医院医疗保障中心药剂科,北京 100853
- 2. 中国医学科学院北京协和医学院人文和社会科学学院生命伦理学研究中心,北京 100730
- 3. 北京大学生物医学伦理委员会办公室,北京 100191
- 折叠
摘要
Abstract
Background The informed consent form(ICF)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 the systematic deficiencies in the design of informed consent forms,indicating the need to further optimize their comprehensibility and readability in drafting,so as to provide reference for ethical practices in future clinical research.关键词
知情同意/临床研究伦理/患者自主权/可理解性/可读性/调查问卷/IgA肾病Key words
informed consent/clinical research ethics/patient autonomy/comprehensibility/readability/questionnaire/IgA nephropathy分类
医药卫生引用本文复制引用
杨千粟,刘帅,张迪,赵励彦,曹江,白楠..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[J].解放军医学院学报,2025,46(10):994-1002,1010,10.
