Institutional review boards recommend that consent forms be written at no higher than an 8th-grade reading level. An analysis of 5,239 US consent forms posted on ClinicalTrials.gov found 91% written above that level, with an average Flesch-Kincaid grade of 11. Readability has improved in recent years, but most forms still ask participants to agree to something written past the level they can be expected to read.

Source: Zai, Faro and Allison, Unveiling readability challenges: an extensive analysis of consent document accessibility in clinical trials, Journal of Clinical and Translational Science, 2024 — doi:10.1017/cts.2024.595.