Readability of model consent forms provided by IRBs

Abstract

Institutional review boards (IRBs) often provide model consent forms for researchers to use or adapt when conducting human subjects research. However, the models themselves often far exceed the 8th-grade reading level recommended for consent forms, with many models measuring grade 12 or higher. In this paper, we look specifically at how muck and how, model consent forms deviate from the desired 8th-grade reading level, as measured by the Flesch Reading Ease formula and the Flesch-Kincaid grade level formula. We discuss quantifiable features measurable by these formulas and by text analysis features available in Microsoft Word (e.g., sentence length, paragraph length, and percentage of passive voice sentences). We outline plans to examine additional features such as nominalization, patterns in the flow of given and new information, and document design. Our findings are designed to help IRBs and researchers prepare consent forms that are more readable and, therefore, more in keeping with legal and ethical guidelines for human subjects research.