Michael K. Paasche?Orlow|Holly A. Taylor|Frederick L. Brancati
Readability Standards for Informed-Consent Forms as Compared with Actual Readability
Johns Hopkins University|Johns Hopkins Berman Institute of Bioethics|Johns Hopkins Berman Institute of Bioethics|Johns Hopkins University|Johns Hopkins University
institutional review boards irbs charged safeguarding potential research subjects limited literacy may inadvertent role promulgating unreadable consent forms hypothesized text provided irbs informedconsent forms falls short irbs readability standards readability influenced level research activity local literacy rates federal oversightto test hypotheses conducted crosssectional study linking data several publicuse sources total 114 web sites us medical schools surveyed irb readability standards informedconsentform templates actual readability measured fleschkincaid scale assigns score basis minimal grade level required read understand english text range 0 12 data level research activity local literacy rates federal oversight obtained organizational web sitesthe average readability score text provided irbs 106 95 percent confidence interval 103 108 fleschkincaid scale specific readability standards found 61 web sites 54 percent ranged 5thgrade reading level 10thgrade reading level mean fleschkincaid scores readability sample text provided irbs exceeded stated standard 28 grade levels 95 percent confidence interval 24 32 p0001 readability associated either level research funding p089 local rates literacy p092 however 52 schools made subject oversight office human research protections 46 percent lower fleschkincaid scores schools 102 vs 109 p0005irbs commonly provide text informedconsent forms falls short readability standards federal oversight associated better readability