The SRA Symposium - College of Medicine

Papers
can be counted (syllables, words, sentences), they cannot take into account other more important
factors that are usually described as document design and layout.
One way to approach patient understanding of consent forms is to comprehension skills needed
to understand science materials (Chall, Bissex, Conard, et al 1996). While their analysis dealt with
qualitative assessments of text difficulty in the sciences, their conclusions are relevant to science
based consent forms in clinical trials. For patients to understand consent forms, they must possess
cognitive abilities not measured by readability formulas, such as: 1) large vocabulary, so they can
understanding uncommon words used in abstract and theoretical discussions, 2) sentence structure
familiarity—understanding long and complicated sentences, often with embedded phrases,
3)extensive prior knowledge—analyzing and synthesizing abstract, theoretical, and technical
information, as well as hypothesis testing and applied science principles.
Subject testing: The real measure of comprehension is not the grade level score of a readability formula,
but how well prospective subjects actually understand the consent process. Wendler (2004)
suggests using postdecision questionnaires (PDQs)to formally assess every subject’s consent not
just cognitively impaired subjects. However, that approach requires some agreement by informed
consent researchers on the definition and measurement of informed consent “understanding,” as
well as collaborative development of PDQs that are psychologically valid and reliable, not based on
rote memory, or comprised of true-false questions (subjects can get 50% correct by guessing). If
done appropriately, PDQs could eliminate some readability compliance flaws and legally be a more
defensible approach to consent form understanding.
Conclusion:
Consent form noncompliance is risky. There are legal risks in which subjects may sue, perhaps in
class action lawsuits, if they believe they experienced dignitary harm because they didn’t understand
the consent form. There are the financial risks for institutions defending themselves against
such lawsuits, and the potential for large financial settlements, either in out-of-court settlements
or in a jury’s recommendations. There are the ethical implications that influence public perceptions
of the researchers and the institution that’s being sued, and there are research risks associated
with recruiting future research subjects.
The inconsistencies found in readability formulas and the research that’s based on such formulas
can be viewed as academic arguments to be discussed by researchers at professional conferences
and in academic journals. But, readability isn’t just about research, it’s about compliance with federal,
institutional, and IRB recommendations. Federal regulatory agencies, research administrators
and IRBs should assess the variety of risks associated with consent forms written at grade leaves
much higher than recommended. If readability compliance is as impossible and inappropriate
as it seems to be, why repeat recommendations that consent forms be written at a 6th-8th grade
reading level if it’s not only impossible to meet that goal, but has the potential to put organizations,
IRBs, and researchers at risk? When it comes to readability of consent forms, be careful what you
ask for; you might not get it.
2005 Symposium Proceedings Book 121