The SRA Symposium - College of Medicine

Liabilities of “unreadable” consent forms
Mark Hochhauser, Ph.D.
Readability Consultant
3344 Scott Avenue North
Golden Valley, MN 55422
Phone: 763-521-4672
Fax: 763-521-5069
E-mail: MarkH38514@aol.com
Papers
Abstract:
Although federal agencies, research departments and IRB web sites commonly recommend that
consent forms be written at a 6th-8th grade reading level, readability research consistently finds
consent form templates and consent forms to be well above that grade level. The gap between
recommended grade level vs actual grade level—a potential compliance issue--creates liabilities
for research administrators, researchers, and sponsors. The University of South Florida and Tampa
General Hospital agreed to a $3.8 million out-of-court settlement in 2000 because of one study’s
“unreadable” consent forms. To prevent such liabilities, departments that rely on readability formulas
must ensure that their researchers and IRBs are familiar with readability formula limitations
identified by technical writing experts over the past twenty years. These include the relevance,
validity and reliability of readability formulas when applied to consent forms, adolescent vs adult
reading differences, readability estimates vs consent form content, layout and design, text comprehension
factors, and recommendations for reader testing instead of consent form testing. Without
such insights, researchers and IRBs will have to deal with the legal, financial, ethical and public
relations liabilities created by the continuing use of “unreadable” consent forms.
Do incomprehensible consent forms cause “dignitary harm?”
A class action lawsuit by 5,000 pregnant women (Hanlon & Shapiro, 2003) was brought against
Tampa General Hospital and the University of South Florida College of Medicine. The plaintiffs
claimed that they became research subjects without being told that required medical tests were
for research (not treatment), and without being asked to consent. Their lawyers argued that the
three-page, single-spaced, grade 14 reading level consent form created “dignitary harm.” Subjects
were presumably harmed by researchers who took away their autonomy to make informed decisions
and thus denigrated them as human beings—even though the subjects were not physically
harmed in the research. The case was settled out-of-court for $3.8 million. The plaintiff ’s lawyers
noted that:
“All parties also agreed, by the end of the case, that readability alone is not sufficient for an
informed consent document….A host of other factors—design, cultural relevance, format,
length, density, and style—all enter into the question of the document’s potential for effective
communication…” (p. 4)
But the legal implications of incomprehensible consent forms go beyond just readability issues.
The authors believe that:
“…a complex and difficult-to-understand informed consent document is conducive to
a coercive atmosphere in the enrollment process in biomedical research. The document
itself is coercive, intentionally or not, when it is unduly long, complex, and incomprehensible.
This type of document sends a message to proposed human subjects that they have
no meaningful role in the process because it is something that can be understood only by
people with greater knowledge than they possess.” (p. 4-5)
2005 Symposium Proceedings Book 115