Formatting, word choice, white space — they all matter in consent forms

Think back to your high school days, when you’d try to tackle a reading assignment from, say, your history textbook. Did you look forward to the prospect of reading page after page of small text, arranged in long paragraphs? Or were you hoping for some illustrations, bulleted lists, and white space to break up all the gray?

Now imagine you’re a potential research participant. Which consent form are you more likely to look at? One that includes pages and pages of text? Or one that includes easy-to-digest images, short sentences and paragraphs, bulleted lists, white space, etc.?

Yes, we are bound by certain requirements regarding consent form content. But there is still room for flexibility in design and presentation of consent documents. Consider implementing any of the following ideas to simplify your consent forms:

  • Use simple language whenever possible. The fewer the syllables, the better (most of the time). The CDC publication titled “Everyday Words for Public Health Communication” has some ideas for simplifying language.
  • Keep sentences short. (See what we did there? Three words. That’s all we needed to relay an idea.)
  • Supplement long consent forms with additional easy-to-read materials, such as brochures or summary sheets. This hint may be particularly useful in an industry sponsored and/or FDA-regulated study that doesn’t allow for much flexibility in the main consent. The sponsor may allow you to add supplemental material in a format that subjects are more likely to actually read.
  • Use bulleted lists instead of paragraph-long sentences list a bunch of items separated by commas or, heaven forbid, semicolons. If ever there was a sign that text needed simplifying, it’s the semicolon.
  • Create white space using wide margins, subheadings, and spaces between paragraphs.
  • Pictures. They’re worth a thousand words. If you’re doing, say, a study of an implantable device, can you add a picture showing where the device will be implanted? Or how about a flow chart depiction of how a subject will progress through a study?