JMU OSP

Module 2
Ensuring Readability

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 document.

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 the participant.

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