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.
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.
You will find more information about this subject as you begin to write the consent document in Module 3.