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Applied Clinical Trials
When it comes to readability, do as the Feds say and not as they do. Federal agencies may recommend that consent forms be written on a junior high school level, but it's a daunting task even for them.
To improve informed consent comprehension, federal agencies such as the FDA, Office for Human Research Protection, and National Cancer Institute (NCI) recommend 6th to 8th grade reading level consent forms. But there isn't a single case of sponsors, researchers or institutions getting in trouble with regulatory agencies or IRBs for writing consent forms well above the 6th to 8th grade reading level.
If they're serious about readability recommendations, sponsors and researchers should be required to certify the grade level of their consent forms, and IRBs should disapprove any forms that do not meet the 6th to 8th grade recommendation. This would bring clinical trial research to a complete halt for a long time, since writing consent forms at a junior high level is practically impossible.
Federal regulatory agencies and IRBs can tell researchers to write consent forms at a junior high reading level, but they provide only generic templates of "readable" consent forms, leaving out most of the important—and complicated—details. If federal regulatory agencies want consent forms to be written at a 6th to 8th grade reading level, they should post examples of consent forms written at that level, not generic templates or plain language recommendations.
Agencies should also follow their own advice. The NCI's (www.nci.gov) "Simplification of Informed Consent Documents" recommends writing forms at an 8th grade or lower reading level, but five NCI documents averaged a grade 14 reading level.
Reading Grade Levels for Five FDA Documents
PROSE The Readability Analyst software's grade level estimates are based on the average of eight readability formulas. Table 1 summarizes the readability of five FDA consumer-based clinical trial documents (www.clinicaltrials.gov); none of the five were written at a 6th to 8th grade level.
Let's briefly consider readability regulations in another industry: insurance. About 39 state insurance departments require specific reading grade levels for insurance policies sold in their states—usually a score of 40 to 50 (Difficult) on the 1948 Flesch Reading Ease Formula (0 = very difficult, 100 = very easy).
Scores of 40 to 50 average about 25 words per sentence and 167 syllables per 100 words—the reading level of 1940 readers who completed high school or some college. Writing at a 6th to 8th grade level (standard to fairly easy) requires 14 to 17 words per sentence and 139 to 147 syllables per 100 words.
If this is the federal and IRB goal, sponsors and researchers should have to certify consent form readability the same way that insurance companies certify their policy's readability.
Although both the FDA and NCI recommend consent forms at a 6th to 8th grade reading level, their own clinical trial information for consumers is actually written at the college level.
Since writing at lower grade levels is harder than it seems, federal agencies (and IRBs) should either require readability certification or eliminate readability recommendations entirely. Otherwise, federal agencies are hypocritically telling sponsors and researchers to: Do what we say, not what we do.