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Quick Guide for Writing Consent Forms in Lay Language

Remember that informed consent is an ongoing, interactive process, not just a form. The form itself is used to document the basis for consent and for the participant’s future reference.

Resources

Tips

  • Visit the IRB Office’s Biomedical & Social Behavioral Consent Templates Page to ensure you start with the most recent, up-to-date, Northwestern University IRB Office consent form template.
  • For lay language suggestions:
  • Use active voice, simple and plain language familiar to non-medical people.
    • Have a lay or non-medical person read your document and ask them questions for comprehension.
  • Tailor the informed consent language to your intended participant population as well as other relevant factors such as study design.
  • Use diagrams and photos to depict study procedures or visit summaries.
  • Make use of “white space” (bullet points rather than text-heavy paragraphs).
    • Using dense paragraphs to cut down on page counts does not help readability.
  • Use consistent terminology, including abbreviations and drug names.
  • Keep sentences short and limited to one thought.
  • Define uncommon terms and acronyms when first used.
  • Consider using alternative media (e.g., pictures, video, tables) to improve clarity and increase prospective participants’ understanding.
  • To test the level and clarity of the consent form, we suggest that you read the form out loud to colleagues/staff and test it on a target audience.
  • The informed consent form should be revised when the PI notes any deficiencies or when additional information will improve the consent process.
  • Use a The Flesch/Flesch–Kincaid readability test (there is one built into MS Word)
    • Make sure that the key information section is written at the lowest possible reading level.
      • You can find the Flesch-Kincaid Grade level in Microsoft Word by:
      • Go to File > Options.
      • In the Proofing tab, check the following options:
      • Click OK.
      • Click to Review > Spelling & Grammar to check your document for spelling or grammatical errors and also see the readability level of your document.
    • The Flesch-Kincade grade level scores are popular in readability literature albeit not 100% accurate. It uses a formula derived primarily from word and sentence length