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.

To improve informed consent form readability:

  • Avoid use of acronyms or abbreviations.
  • Use familiar words instead of jargon.
  • If you must use terminology, briefly define it.
  • Be consistent with any words or terminology.
  • Change passive voice to active voice (i.e. sentence's subject is doer of act).
  • Make sentences short, simple and direct.
  • Use words with no more than 3 syllables.
  • Break all compound sentences (and, but, because) into two short sentences.
  • Create short paragraphs. Support one idea per paragraph.
  • Use bullets, tables or charts to make ideas clear.
  • Limit line length to 30-50 characters and spaces.
  • List procedures in chronological order.
  • Use an easy to read font and type size, suitable for subjects, such as 12 pt. Times New Roman or 10 pt. Arial.
  • Restrict procedures to those the subject will experience and understand (i.e. tell them you will give survey rather than naming an unfamiliar instrument, or that you are testing blood for a particular reason rather than providing the technical name).