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.
- 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 NU IRB suggested language: https://irb.northwestern.edu/resources-guidance/consent-templates-hipaa-requirements/suggested-consent-language/
- Use NCCN suggested language: https://www.nccn.org/icl/default.aspx
- 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
- Make sure that the key information section is written at the lowest possible reading level.