Readability of Consent Forms: Sponsor Templates versus Locally Approved Consent Forms

Readability of Consent Forms: Sponsor Templates versus Locally Approved Consent Forms
Dissertation
Joyce D. Brown
Rush University ProQuest Dissertations Publishing, 2023
Abstract
Background
Respect for person is a basic ethical principle of the Belmont Report and includes the need to treat research participants as autonomous individuals during the consenting process. Federal guidance has recommended consents be written at a 6th to 8th grade reading level. However, it is not clear that these reading recommendations actually occur in reality. The overall goal of this project explores whether the results of sponsor provided, and Institutional Review Board (IRB) approved consents at a local site achieve the desired reading levels.
Methods
This quality improvement project identified research studies in the Pulmonary and Critical Care Division of Rush University Medical Center from 2014-2023, where a sponsor consent and a Rush IRB consent were both available. Readability software calculated consent comparison scores. Data resulted from use of the Flesch Reading Ease (FRE), Flesch- Kincaid Grade Level (FKRL), and Simple Measure of Gobbledygook Index (SMOG) scores.
Results
After reviewing the research study records, 18 studies met inclusion criteria for the project and consents selected for the medical intensive care unit recruitment (39%) and (61%) for outpatient pulmonary disorders research. The eighth-grade level for each metric was 60 for FRE, 8 for FKGL and 8 for the Smog Index score. Using a t-test, the mean readability metrics for the sponsor consents was greater than the 8th grade (FRE: 53.75 (SE=1.56), t-test = -3.98; p = < 0.001; FKGL: 9.74 (SE=0.29), t-test = 5.83; p = < 0.000; Smog Index: 12.15 (SE=0.23), t-test = 17.62; p = < 0.000). Similarly, the mean readability metrics for Rush IRB consents was greater X than the 8th grade (FRE: 53.51(SE=0.90), t-test = -7.17; p = < 0.000; FKRL: 9.90 (SE=0.17), ttest =  10.61; p = < 0.000; Smog Index: 12.20 (SE=0.14), t-test = -29.13; p = < 0.000). Paired ttest results conducted on the sponsor and IRB consents show no difference on any of the readability metric and therefore show no statistically significant difference (sponsor vs. Rush IRB for FRE 53.75 vs. 53.51, t-test = -2.32, p = 0.81); for FKGL 9.74 vs 9.90; t-test = 0.83, p = 0.41, and for SMOG 12.15 vs 12.20, t-test = .33, p = 0.73.
Discussion
Readability scored both the sponsor and IRB consent templates above the 8th grade reading level. Additional research is warranted to advance the properties of readability in the sponsor and IRB templates.