The SRA Symposium - College of Medicine

Papers
facing patients being recruited for clinical trials. Consent form writers face difficult conflicts.
While they’re expected to write consent forms that are compliant with the three requirements
listed above, they must also include up to 25 topics in the consent form, even though a prospective
subject’s working memory can store only about three-to five pieces of information.
Writing and designing consent forms: Considering the consent form as a “form” to be designed
and not just pages of text to be typed offers new ways of presenting consent form information.
Hochhauser (2003) identified several plain English strategies that might improve understanding,
including:
• one-page plain English consent form summary that addresses the 14 “basic” and
“when appropriate” elements of informed consent,
• a table of contents to help readers find key section in the consent form,
• a question and answer format,
• use of larger fonts and bold or italicized text to emphasize key points,
• using tables to summarize monthly visits, risks, etc.,
• using bullet points instead of sentences to summarize lengthy topics,
• including space for a subject’s questions and the researcher’s responses after
each section.
Added to these plain English strategies are standard document design techniques that enhance the
visual appeal of the consent form. These include text choices (serif type faces, at least a 12 point
font and lowercase text), headings and subheadings (lowercase with no periods and close to the
next line to avoid “floating” headings), and formatting (about 8-12 words per line, equal spacing
between words, unjustified margins, a two-column newsletter format, etc.). Too many consent
forms look as though they have been typed instead of designed; they have no visual appeal.
Readability issues
Because consent forms are required to be written in understandable language to adequately inform
subjects so they can make enlightened decisions, both federal regulators and IRBs have arbitrarily
chosen reading grade level as a way to meet those requirements. That’s why the standard recommendation
is for consent forms to be written at a 6th to 8th grade reading level. But that simplistic
recommendation fails on several counts.
Formula validity and reliability: Readability formulas are 30 to 65 years old; the classic Flesch
Reading Ease Score was developed by Rudolf Flesch in the mid 1940s. It’s not clear that what
Flesch meant by an 8th grade reading level in 1945 is the same as an 8th grade reading level in
2005. Although most readability formulas were designed to be calculated “by hand,” computers
made it possible to convert such formulas into readability software programs. Unfortunately, that’s
more difficult than is usually recognized. While it’s easy for a person to count syllables, words, and
sentences, it’s much harder to write a software program to do that. Because readability software
programs aren’t as accurate or consistent as they should be, many consent form readability studies
are seriously flawed. For example, the Flesch-Kincaid readability formula is widely used because
it’s included in Microsoft Word. But most consent form writers don’t know that Microsoft’s version
of the Flesch-Kincaid does not report grade levels above 12, although the formula can calculate
up to a grade 17 level. While the formula’s results should be the same in every software package,
it isn’t. Hochhauser (1997) compared six software programs that used the Flesch-Kincaid on one
consent form. He found that the Flesch-Kincaid grade levels reported ranged from 12.1-14.5—a
difference of 3.5 grades.
106 2005 Symposium Proceedings Book