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Informed Consent Forms: Does Readability Improve Comprehension?

National surveys have indicated that possibly as many as 90 million Americans have low-to-marginal literacy skills. As a consequence, many patients may not fully comprehend the content of consent forms, typically written at a level of reading ability attained by college students, that they must read and sign before being allowed to participate in clinical research studies. Davis et al. (p. 668) investigated whether or not a consent form designed for use in an actual clinical trial could be, with input from patients, redesigned and rewritten to make it more reader-friendly and more easily understood. The authors found that although their modified consent form (written at a seventh grade level of comprehension) was less intimidating and more easily read than a standard consent form (written at a college level), the levels of comprehension were similar for the two forms.

“Adults [with inadequate literacy skills] may not be able to read and understand the forms that they are signing, and they may not let clinicians or researchers know their problem.”