biostudies-literatureUnknown8(1)Zai AH<h4>Background</h4>Clinical research trials rely on informed consent forms (ICFs) to explain all aspects of the study to potential participants. Despite efforts to ensure the readability of ICFs, concerns about their complexity and participant understanding persist. There is a noted gap between Institutional Review Board (IRB) standards and the actual readability levels of ICFs, which often exceed the recommended 8th-grade reading level. This study evaluates the readability of over five thousand ICFs from ClinicalTrials.gov in the USA to assess their literacy levels.<h4>Methods</h4>We analyzed 5,239 US-based ICFs from ClinicalTrials.gov using readability metrics such as the Flesch Reading Ease, Flesch-Kincaid Grade Level, Gunning Fog Index, and the percentage of difficult words. We examineJournal of clinical and translational sciencee125https://www.ebi.ac.uk/biostudies/studies/S-EPMC11428065biostudies-literatureUnveiling readability challenges: An extensive analysis of consent document accessibility in clinical trials.PMC11428065Allison JFaro JMZai AHfalseUnveiling readability challenges: An extensive analysis of consent document accessibility in clinical trials.<h4>Background</h4>Clinical research trials rely on informed consent forms (ICFs) to explain all aspects of the study to potential participants. Despite efforts to ensure the readability of ICFs, concerns about their complexity and participant understanding persist. There is a noted gap between Institutional Review Board (IRB) standards and the actual readability levels of ICFs, which often exceed the recommended 8th-grade reading level. This study evaluates the readability of over five thousand ICFs from ClinicalTrials.gov in the USA to assess their literacy levels.<h4>Methods</h4>We analyzed 5,239 US-based ICFs from ClinicalTrials.gov using readability metrics such as the Flesch Reading Ease, Flesch-Kincaid Grade Level, Gunning Fog Index, and the percentage of difficult words. We examine2024-01-01T00:00:00Z20242026-04-08T15:53:44.492Z2025-04-04T12:53:57.33ZS-EPMC114280653934569210.1017/cts.2024.595