SECTION 2 - READABILITY IN THE RESEARCH SETTING
Consent form readability deserves attention
Many IRBs are growing more attuned to low readability—and requiring study teams to improve their consent forms.
Federal regulations require consent forms and other recruitment materials that are "understandable to the subject."
Protection of Human Subjects. Federal Regulations Title 45, 46.109 and 50.20 (1993)- Not just language choice (e.g., Spanish versus English). We need to make sure
the information makes sense.
Bottom line: Many reasons to provide easy-to-read information and no reason not to . . .
