The SRA Symposium - College of Medicine

Papers
How “readable” are consent forms?
FDA requires that “the information that is given to the subject or representative shall be in language
understandable to the subject or the representative,” and that “technical and medical
terminology should be avoided or may be explained.” Although the FDA does not require consent
forms to be written at a specific grade level, IRBs and researchers often require consent forms to
be written at an 8th grade reading level, assuming that consent forms at that grade level will be in
language that subjects can understand. But consent forms seldom meet such required standards.
IRB readability recommendation discrepancies
A 2003 study looked at IRB readability standards for informed consent forms at 61 of 114 web
sites of US medical schools and compared those standards to the consent forms’ actual readability
(Pasasche-Orlow, Taylor, Brancan, 2003). They found that while readability standards ranged from
5th-10th grade (with an average 8th grade recommendation), the average readability score of sample
text from consent forms exceeded those standards by about 2.8 grades. The authors concluded
that the sample texts given to researchers by medical school IRBs didn’t meet the readability standards
of those IRBs. What they did not conclude was that such discrepancies might represent legal
non-compliance should a lawsuit be filed over unreadable consent forms.
Oncology consent form discrepancies
Sharp’s (2004) analysis of 107 oncology research consent forms found an average 11.9 grade level
(Gunning Fog Index); none of the consent forms was written at or below an 8th grade reading
level. Since the National Cancer Institute recommends 8th grade for oncology consent forms and
OHRP recommends a 6th-8th grade level, all 107 consent forms were non-compliant with federal
recommendations. However, using a different readability formula—such as the Flesch-Kincaid—
may have resulted in lower grade level, since the Fog Index tends to score “high” on technical
materials. Since readability formulas do not all give the same results, perhaps researchers should
report grade levels from several readability formulas instead of only one.
Institutional risks of readability discrepancies
On the one hand, such findings continue to point out that consent forms are probably too hard for
average patients to understand. On the other, data showing consent forms written at grade levels
exceeding OHRP, NCI and IRB recommendations suggests that these consent forms are non-compliant
with regulatory recommendations. One IRB website states that “Consent documents should
be written in a language appropriate to the subject population, but never higher than 8th grade
readability level.” Never? Does that IRB document its refusal to approve consent forms above an
8th grade level?
One Medical College Human Assurance Committee states that “Children’s Assent documents
should be written on a second grade reading level.” Based on the Fry Readability Scale, a second
grade reading level equals about 8 – 10 words per sentence and about 110-120 syllables per 100
words; in other words, very short sentences with very short words. Even if that statistical grade
level could be met, do young children have the cognitive skills to understand the FDA’s “basic elements”
of informed consent even if they are written at a second grade level?
Given federal agency and IRB recommendations, how is it even possible for statistically unreadable
consent forms to reach an IRB? Even though instructions for writing consent forms include
readability recommendations, they do not include a requirement that researchers certify that their
consent forms are in compliance with those recommendations. Either researchers are completely
ignoring readability recommendations, or finding that they cannot write consent forms at the
grade levels recommended by federal agencies and IRBs.
116 2005 Symposium Proceedings Book