Institutional Review Board (IRB) review lacks impact on the readability of consent forms for research

Consent forms in research are a source of current and retrospective information for the subject, a "prompt" for the person who is obtaining consent, and a documentation of the "informed" consent process and its adequacy. Occasionally, these forms may be administered by inexperienced trainees or ancillary personnel, and thus stand virtually alone. Therefore, the forms must be inherently comprehensible to the subjects. To test whether this is the case, 65 new applications were randomly selected from 13 consecutive IRB agendas, and their consent documents were computer-analyzed (Flesch/Fry scoring) after correction for expected confounding features, such as lists, tables, and polysyllabic proper names and jargon. Mean U.S. school grade for 70% comprehension (Fry score) was 15.03 +/- 0.19 (standard error of the mean), implying readability by 37.4 +/- 1% of the U.S. adult population. In contrast, a consecutive sampling of 21 Ann Landers columns yielded a mean Fry score of 7.67 +/- 0.5 (p < 0.01; readable by 75 +/- 3%). Fifteen Reader's Digest articles yielded a mean Fry score of 9.95 +/- 0.65 (p < 0.01; readable by 59.1 +/- 3%), and 15 "Talk of the Town" columns from The New Yorker averaged a grade level of 13.3 +/- 0.83; p < 0.01; readable by 42.7% +/- 4.8%). No document was improved by more than one grade level by the IRB review process, and most were unchanged.(ABSTRACT TRUNCATED AT 250 WORDS)