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The Cincinnati Children’s Hospital Medical Center IRB and a special task force developed guidance and a template for improving and simplifying informed consent forms. Among the guidance’s suggestions are these tips for making an IC form more readable:
• Write the consent document to a sixth-to-eighth-grade reading level.
• Use Arial, Calibri, or other plain font in 11 point or larger size.
• Use underline, bold, or boxes to emphasize important points. Do not use italics or all caps.
• Have a clear page layout with a lot of white space.
• Use page numbers, bullets, graphics, tables, and flow charts.
• Avoid technical, medical, legal jargon.
• Spell out acronyms and abbreviations the first time they are used.
• Be consistent with words and terminology throughout the document.
• Keep words to three syllables or fewer and write short, simple, direct sentences.
• Limit paragraphs to one idea and keep them short.
• Use an active voice and use second person with the pronouns "you," "we," and "I."
The template also offers examples of preferred language. Here is a sample:
• Instead of saying "trial" or "experiment," use "research study" or "project."
• Instead of using the word "randomization," say, "like flip of a coin or like drawing numbers from a hat."