Tips for Simplifying Consent Forms

  • Be familiar with the characteristics of your target audience (e.g. demographics, previous knowledge, experiences. Etc.)
  • Know what is the most relevant information to communicate regarding the study/procedure.
  • Early in the document, orient the reader to the study/procedure purpose.
  • Define treatment schedules clearly and specifically (e.g. specify “Monday through Friday” instead of “five days”)
  • Use headings and advance organizers to introduce informational components.
  • Write paragraphs in a logical order.
  • Convey one idea per paragraph.
  • Write in an active voice.
  • Avoid polysyllabic words.
  • Do not compromise the meaning by using simpler but less familiar terms.
  • Use short sentences.
  • Vary sentence length.
  • Be consistent with words and terminology.
  • Define technical or difficult words.
  • Have a 50/50 blend of white space and type.
  • Use personal, rather than impersonal, pronouns.
  • Use upper case and lower case for the text. (All capitals are hard to read.)
  • Use a readable type style—usually one with serifs—the little “feet” on the bottoms of the letters that you see in this type. (e.g. Helvetica, Times)
  • Use 12-14 point type for text.
  • Use 16-18 point bold type for headings.
  • Build in review mechanisms.
  • Use summary techniques.
  • Determine readability using the SMOG formula.
  • Employ testing methods.
  • Be prepared to revise.

Most important: You must have the patient repeat back to you in their own words what you want them to know.  Never assume they have understood the reading material.  Have them tell you what they think you have told them. 

Another example. Again, the bold words are multi-syllabic and the sentence count is before each sentence.  Assume the same number of big words extrapolated to 30 sentences.  (14 X 6 = 84—so this is at a 12th grade reading level.)

“(1) A positive HIV test indicates that you are infected with HIV.  (2) If you are infected, you can pass the virus to other people. (3) Inaccurate positive and negative test results occur occasionally.  (4) For this reason, a negative test result does not guarantee that you are not infected.  (5) Rarely, a positive test result is inaccurate and indicates that you are carrying HIV even if you are not.”