Consent Forms, Lower Reading Levels, and Using Flesch-Kincaid Readability Software
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Consent Forms, Lower Reading Levels, and Using Flesch-Kincaid Readability Software
Kris A. Wolterr, PLD' Clinical Research Program Director. University of North Carolina Wilmington. Wilmington. North Carolina Micboel R. Howell, PbD, RAC** MORIAH Consultants. Yorba Linda. California
Key Words Consent forms; Comprehension; Reading level Correspondence Address Kris A. Walters, PhD, University ofNorth Carolina. Wilmington, 601 South College Road, Wilmington. N C 28403 (email: [email protected]). 'This research was conducted in partial filfillment ofthe requirements for a PhD degree gran ted by Tour0 University International in August 2006. "PhD thesis advisor.
The US Food and Drug Administration requires the use of a consentform as part of the protection of human subjects in clinical trials. To help increase the probability of consent form comprehension, the biopharmaceutical industry, FDA, National Cancer Institute, and National Institutes of Health often advise developing consent forms between a sixth and eighth grade reading level. Frior studies have examined consent comprehension at differentreading levels. However, prior study results are often inconsistent, do not all utilize consents conforming to the code of Federal Regulations (CFR), and do not all report the validity or reliability of the comprehension measurement t d used or the studies' sample populations that are homogeneous and possess limiting characteristics. Thus the question remains whether lowering the reading level of a CFR-conforming consentfonn increases comprehension in a population devoid of predefined characteristics. Also unanswered is whether other variables, together or separateIy such as age, gender, income level, and prior exposure to consent forms affect comprehension of consent forms written at different reading levels. To establish baseline research regarding the comprehension-reading level relationship, a study was petformed utilizing a heterogeneous population of individuals waiting for jury ser-
vice. The eflects on comprehension by age, income, gender, prior exposure to consent forms, and 6th versus loth grade reading level consents were examined. The consent forms' reading levels were determined using the Flesch-Kincaid Grade Level scale in Microsoft Word. Comprehension was measured using a validated Ls-question multiple-choice questionnaire that subjects completed after reading the consent forms. Statistical analysis of the effectsby age and consent level on comprehension resulted in a significant main effect on comprehension by age, but no eflect by consent level. A comparison indicated that only the 30-44 and 60-75 age groups demonstratedsignificantdifferences in comprehension. An analysis of the eflects on comprehension by gender, income, and consenting to research in the past resulted in no significant main or interaction effects. Additional analysis confirmed that only age significantly affcted comprehension. The research concluded that gender, income, prior exposure to consent forms, and lowering consent reading lev
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