Consent Form Readability
Providing easy-to-understand health information is a fundamental part of patient-centered research and an important ethical, compliance, and safety concern. Recent changes to the Federal Regulations governing human subject research (the “Common Rule”) have included a focus on improving the readability of consent forms and include regulations requiring understandable language, and organization and presentation of information that facilitates understanding.
In response to these requirements, beginning later this year, consent forms must satisfy minimum readability standards.
Though we expect to extend the standard to other sections of the consent, initially only the readability of the invitation and summary section will be assessed.
The summary section must have Flesch Kincaid reading level ≤8 and Flesch Reading Ease ≥ 60. Readability may be scored within the RSS application by clicking on the “Readability” button. In addition, RSS will provide an area where the writer can work with consent form language and receive immediate feedback on readability, and then cut-and-paste that language in the summary.
Consent forms not meeting these minimum readability measures will be returned to the investigator for modification.
To assist investigators and their staff in developing necessary skills to write effective consent forms, the PI and the Lead Coordinator, or person responsible for writing the consent form, must complete online training through PRISM (Program for Readability in Science and Medicine). The hour-long training covers health literacy and readability, plain language strategies and examples, and interactive editing examples and exercises.