Resources to adjust the reading level of consent, assent and authorization forms
Consent, assent and authorization forms should be written at a maximum 8th grade reading level. For long consent forms (more than 5 pages), the IRB requires the use of a summary information sheet at the beginning of the form that highlights the critical information about study procedures and risks of participation.Helpful Tools for Creating Effective Consent Forms:
- The Federal Plain Language Guidelines and NIH Plain Language site provide concrete advice for presenting technical information in an understandable way.
- The CDC’s Simply Put: A Guide for Creating Easy-to-Understand Materials (PDF) recommends techniques that can be applied to consent documents.
- The CDC's Clear Communication Index can help you evaluate the effectiveness of your consent documents.
- Readability-Score.com uses several calculators (e.g. Flesch-Kincaid) to assess readability and grade level of text.
- Tools for simplifying medical and research-related terminology:
- National Patient Safety Foundation’s Words to Watch – Fact Sheet (PDF)
- The University of Iowa: Medical Terms in Lay Lanugage
- National Comprehensive Cancer Network (NCCN) Informed Consent Language Database
- CDC Plain Language Thesaurus
- University of Michigan’s Plain Language Medical Dictionary