%0 Journal Article
%T An Analysis of Informed Consent Form Readability of Oncology Research Protocols
%A Amy T. Buser
%A Benjamin Munley
%A Joseph L. Breault
%A Lydia A. Bazzano
%A Stephanie Gaudreau
%J Journal of Empirical Research on Human Research Ethics
%@ 1556-2654
%D 2018
%R 10.1177/1556264618795057
%X Twenty-two percent of adults in the United States have only basic health literacy skills. We used a multiple linear regression model to identify associations between readability of informed consent documents with study sponsor, study phase, and approval year using a sample of 143 oncology studies at Ochsner Medical Center. The M ¡À SD Flesh-Kincaid Reading Grade Level (RGL) was 10.33 ¡À 0.85 and Flesh Reading Ease (FRE) was 52.89 ¡À 5.49. National Cancer Institute studies had a significantly lower mean RGL and FRE as compared with other sponsors (RGL 9.85 ¡À 0.66 vs. 10.72 ¡À 0.79; p value < .0001). Mean RGL did not differ by study phase. Future research should include assessment and improvement of the readability of informed consent documents
%K consent forms
%K oncology studies
%K readability
%K protocols
%K health literacy
%U https://journals.sagepub.com/doi/full/10.1177/1556264618795057