FALSE.
You may have heard that consent forms should be written at a reading level that’s no higher than what an 8th-grader could understand. However, this bit of conventional wisdom is just that – conventional wisdom, and not a regulatory requirement. Instead, regulations at 21 CFR 50.20 and 45 CFR 46.116 require information given to potential participants during the informed consent process to “be in language understandable to the subject,” without specifying a particular reading level. UAMS IRB policy 15.1 repeats this regulatory requirement and then says consent forms “should be written” at or below an 8th-grade level. The 8th-grade level is fairly simple to measure using common word processing programs, but it still does not guarantee understanding. The length of the consent form and the target population also weigh into whether the IRB will consider the consent form appropriate. Some patients with chronic diseases will know so much about their condition that they could understand highly technical language about it, while some consent forms contain so much scientific and/or legal jargon that only a scientist or lawyer could understand them.
The IRB will consider the entire consent process when it reviews consent forms — who will conduct the consent discussion, how much time subjects will have to consider participation before signing the form, whether any easy-to-understand information such as a video or brochure supplement a long and complicated consent form, etc. The consent process extends far beyond the form, so when designing (or reviewing) consent processes, keep all the possibilities in mind to ensure that you have maximized the opportunity to get truly informed consent.
Our thanks to Regulatory Myths in Clinical Research (Brian A. Gladue, author) which appeared in the September 2014 edition of Journal of Clinical Research Best Practices, for publishing the article from which the above was drawn.