Abstract
The informed consent process can be viewed as a sales presentation, with the consent form serving as the written advertisement for the drug research. So viewed, drug companies can use basic document design, layout and typography principles from advertising, as well as strategies from the “plain English” movement both to improve recruiting strategies and enhance participant understanding.
This article evaluated 12 consent forms for investigational drug studies submitted to a Minnesota hospital institutional review board. Consent form text characteristics were compared to recommendations from the National Cancer Institute. Computer analyses judged the consent forms as difficult to read at a grade 13 to 14 reading level; forms included too many uncommon words, too many words per sentence, and too few active voice sentences, giving a “poor” overall style rating. The 12 forms did not always meet good principles of document design in terms of typeface, paragraph justification, and words per line. Several strategies for testing the consent form and reader comprehension were suggested.
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