IRB Consent Form Readability Tips

Tips to Writing a Readable Form

According to the 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 a reabability between the 6th-8th grades, Marywood University's IRB understands that readability may be skewed by such factors as the use of formal names, definitions, or even the analysis program itself. As a result, our IRB requires a readability at or below a 10th grade reading level for the general public. However, readability may need to be decreased depending on the particular population under study. For children or those with impaired decision-making capacity, assent or consent forms need to be developmentally appropriate.

Below is a list of tips to make your consent form more reader friendly:

  • Avoid use of acronyms or abbreviations.
  • Use familiar words instead of jargon. Define terminology if it absolutely must be used.
  • Be consistent throughout the document with any words or terminology.
  • Change passive voice sentences to active voice (i.e. subject is doer of act).
  • Use words with no more than 3 syllables.
  • Make sentences short, simple and direct.
  • Break all compound sentences (and, but, because) into two short sentences.
  • Create short pargraphs. Support one idea per paragraph.
  • Limit line length to 30-50 characters and spaces.
  • List procedures in chronological order.
  • Use an easy to read font and type size, making sure it is suitable for the participants involved. For instance, 12 point Times New Roman is widely accepted for the general public.
  • Restrict procedural descriptions to those the participant will experience and understand (i.e. tell them you will give a test or survey rather than naming the actual tool, or in clinical studies, that you are testing blood for a particular reason rather than naming the specific test).