The SRA Symposium - College of Medicine

For subjects experiencing research-related injuries or “dignitary harm,” could your institution
legally justify sponsors and researchers who write and IRBs that approve consent forms that do
not meet federal or institutional guidelines? Could your institution justify in a deposition or in
court the extensive use of consent forms at a grade 12-14 reading level—4 to 8 grades higher than
recommended? If not, is your institution willing to deal with media stories such as “University
approves unreadable research” or “Hospital violates own ethics rules?” What impact would these
stories have on the reputation of your institution and researchers, and their ability to recruit future
research subjects?
Informed consent communication problems
Both proponents of readability formulas (such as Klare) and opponents (such as Redish, Shriver)
agree on some of the most common problems found with readability formulas, the writers who
use and misuse them, and reader understanding. Federal agencies and IRBs that uncritically
recommend readability formulas seem completely unfamiliar with the extensive research done on
the use and misuse us of these formulas (e.g., Davision & Green, 1988; Zakaluk & Samuels, 1988;
Chall & Dale, 1995). Although consent form researchers often cite other studies on informed consent
readability, they almost never cite research on the strengths and weaknesses of readability formulas
themselves. Such omissions suggest that researchers, journal editors, and peer reviewers are
unaware of readability formula research issues. Table #1 summarizes major readability problems
in the context of informed consent, addressing issues that are not covered in regulatory agency or
IRB readability guidelines.
Table #1: Summary of informed consent problems
Readability formula problems Consent form writer problems Consent form reader problems
Formula relevance Consent form layout/design Adolescent vs adult readers
Validity and reliability Not cleaning files Text comprehension
Readability estimates vs consent
form content
Papers
Misusing readability formulas Reader testing vs consent form
testing
Readability formula problems:
Formula relevance: Are readability formulas relevant for clinical trial consent forms? Most formulas
were designed for textbook selection in elementary and secondary schools to ensure
that students weren’t expected to read books that were too hard to understand. Such readability
formulas are about 30-60 years old; Rudolf Flesch’s Reading Ease formula dates from 1948, while
the revised 1995 Dale-Chall Formula is based on data collected in the late 1970s. Because reading
level estimates are based on how reading skills from 50 years ago, it’s not at all clear if an 8th grade
reading level in 1948 (original Dale-Chall) or 1968 (Gunning Fog Index) or 1975 (Flesch-Kincaid)
is easier, the same, or harder than an 8th grade level in 2005.
Validity and reliability: Some formulas, such as the Flesch-Kincaid, were developed for technical
materials, but no readability formulas have been developed specifically for informed consent
forms. Thus, there is no data on the validity and reliability of readability formulas for informed
consent forms in adult population.
Reliability usually refers to an instrument’s ability to give consistent results over time. But in the
context of readability formula software, reliability means the ability of different readability software
programs to give the same result for the same formula. Readability formulas generally rely on
counts of the number of words in a sentence and the number of syllables per word. While that’s an
easy calculations for researchers to do “by hand,” it’s much harder to write software programs to
accurately count words and syllables. Some programmers estimate syllables based on the number
2005 Symposium Proceedings Book 117