Can Meaningful Use Improve Informed Consent Forms that Advance Health Literacy?


Research shows that ICFs used in clinical studies are long (> 20 pages), written at high readability levels (high school), and accompanied by complex explanations, thereby impacting participants’ comprehension and ability to make autonomous and voluntary decisions. Published benchmarks suggest ICFs should be less than eight pages and written at an eighth grade reading level with simple explanations for easy readability.

This descriptive study replicates, on a smaller scale, the ICF review by Kass, Chaisson, Taylor, & Lohse (2011). It examines length, readability, and complexity of ICFs from the National Institutes of Health, Division of Microbiology and Infectious Diseases within the National Institute of Allergy and Infectious Diseases.

Five hundred ICFs, approved between 2011-2014, were reviewed. Length was calculated by a formula (number of words/250). Readability and complexity were determined utilizing Flesch-Kincaid readability statistics. The presence of legalese type language was recorded.

Sixty ICFs (12%) met inclusion criteria. The results revealed an average page length of 26 pages (9.4-40), readability at a 10th grade level (7.4-12 grade), and a difficult to understand reading ease score of 54% (42.6-69.3%). Legalese was not present. Only one ICF was shorter (13.4 pages) with better readability (7th grade) and easily understood reading ease score (69.3%).

The reviewed ICFs were excessively long, readability too high, with complex language, demonstrating similar results to Kass (2011). Future work on ICFs should focus on developing shorter forms, with simpler language that are easily understood, aid comprehension and help to inform decision making. This study raises an important question: Could adopting a principle of meaningful use (similar to, with the goal of using information to its fullest capabilities, improve health outcomes by guiding ICF practice, policy, and regulatory change?