Readability of the consent document is an important component of
the process. Your consent document information should be presented in
nontechnical terms at a level that your audience can understand. If your
document is not understandable, a claim could be made that the
participant did not understand what was signed. A consent document must
be made readable but without compromising the content.
- Direct it at an eighth-grade reading level.
- Use simple, straightforward sentences.
- Use commonly recognizable terms and measurement amounts.
- Avoid the use of jargon or technical language, and explain
terms that may not be easily understood.
When you have
finished writing the consent document, ask a lay person to read and
explain it to you. A reader who has no association with the study can
often help you to identify difficult or confusing areas in the
Study participants can not be excluded based on language barriers. If you
have a participant who does not understand the language of the consent
document, you must present a translated consent document or arrange for a
qualified interpreter to translate your explanation and questions from
You will find more information about this subject as you begin to write
the consent document in Module 3.