INFORMED CONSENT FOR CLINICAL-TRIALS - A COMPARATIVE-STUDY OF STANDARD VERSUS SIMPLIFIED FORMS

Background: A high level of reading skill and comprehension is necessa ry to understand and complete most consent forms that are required for participation in clinical research studies. This study was conducted to test the hypothesis that a simplified consent form would be less in timidating and more easily understood by individuals with low-to-margi nal reading skills. Methods: During July 1996, 183 adults (53 patients with cancer or another medical condition and 130 apparently healthy p articipants) were tested for reading ability and then asked to read ei ther the standard Southwestern Oncology Group (SWOG) consent form (16t h grade level) or a simplified form (7th grade level) developed at Lou isiana State University Medical Center-Shreveport (LSU), Participants were interviewed to assess their attitudes toward and comprehension of the form read. Then they were given the alternate consent form and as ked which one they preferred and why, Results: Overall, participants p referred the LSU form (62%; 95% confidence interval [CI] = 54.8%-69.2% ) over the SWOG form (38%; 95% CI = 30.8%-45.2%) (P = .0033), Nearly a ll participants thought that the LSU form was easier to read (97%; 95% CI = 93.1%-99.9%) than the SWOG form (75%; 95% CI = 65.1%-85.7%) (P<. 0001), However, the degree to which the participants understood the fo rms was essentially the same for the LSU form (58%; 95% CI = 48.6%-67. 0%) and the SWOG form (56%; 95% CI = 43.8%-66.8%). Implications: These findings raise serious questions regarding the adequacy of the design of written informed consent documents for the substantial proportion of Americans with low-to-marginal literacy skills.