Tips to Writing a Readable Form
According to the Common Rule's general requirements for informed consent under 45 CFR 46.116, "The information that is given to the subject or the representative shall be in language understandable to the subject or the representative."
While most Institutional Review Boards require reabability scores between grades six and eight, Marywood University's IRB understands that readability may be skewed by formal names, definitions, or even the analysis program itself. As a result, it should be at or below a tenth grade reading level for the general public. However, it may need to be decreased depending on the population under study. For children or those with impaired decision-making capacity, assent or consent forms also need to be developmentally appropriate.