Assessment of Length and Readability of Informed Consent Documents for COVID-19 Vaccine Trials

Key Points Question What are the accessibility and understandability for average audiences of current informed consent documents for the COVID-19 vaccine trials? Findings This quality improvement study of 4 informed consent documents from 4 major COVID-19 vaccine trials found all to be overly long and complex, exceeding a grade 9 language complexity and requiring a mean of 35 minutes to read the entire document. It was possible to reduce the length of the documents by more than 50% and use more broadly understandable language with a grade 7 or 8 reading level. Meaning These findings suggest that informed consent documents may fail to succinctly explain the studies to participants of all reading levels and that it is possible to improve these documents to increase participant accessibility.