Consent Writing Tips
The following tips are presented to assist investigators in effectively communicating with potential research subjects:
- Write simply
- Aim for 8th grade or lower reading level. Microsoft’s Word readability tools can provide a general indication of the reading level. The HSC recognizes that 8th grade level may be difficult to achieve in biomedical research; however, the suggestions below will lower the language level and improve comprehension.
- Write short, simple, direct statements.
- Use active verbs.
- Keep paragraphs short and limited to one idea. Avoid large blocks of printed text.
- Use a conversational tone. Some research indicates that comprehension is improved with a question-and-answer consent format.
- Use lay language for medical terms. For example, substitute “high blood pressure” for hypertension; substitute “adjust” for titrate; substitute “measure” for assess.
Lists of simplified terms:
- Use reader-friendly layout and visual aids
- When applicable, investigators are encouraged to use the consent templates posted on the HSC website.
- If none of the templates seem appropriate for your study, please contact the HSC office. Office staff can help in developing your consent document.
- Refer to our consent form checklists
- Consent checklist for FDA-regulated research
- Consent checklist for non-FDA research
Dec 18, 2012