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

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.