The Informed Consent Form: Document Development and Evaluation

Abstract

The informed consentprocess 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 justifcation, and words per line. Several strategies for testing the consent form and reader comprehension were suggested.

Are Patient-reported Outcome Measures in Orthopaedics Easily Read by Patients?

“…Applying different formulas to the same text may yield different results, whereas selecting a single formula could bias our results. For example, applying the Simplified Measure of Gobbledygook (SMOG) formula to the DASH questionnaire gives a score that indicates it would be easily understood by 12-year-old subjects (7 th grade), whereas using the FRES formula suggests it is best understood by 18-to 22-year-old subjects (undergraduates) [2,46]. Because we did not compare the FRES with other readability scores, our results can apply only to FRES.…”

“…Non-English PROMs were not assessed as most readability scores are not validated for use in any other With the majority of medical negligence claims related to poor communication, it is essential that written healthcare material be easily understood [10]. In 1999 Tampa General Hospital paid USD 3.8 million in compensation because signed consent forms were written at a level that exceeded patients' understanding [46,99]. Medical organizations in the European Union are legally liable for text that is difficult to understand [16].…”

“…It also is used in numerous other industries such as education and banking, and is the preferred readability score for Microsoft 1 Office (Microsoft 1 Corporation, Redmond, WA, USA); US courts accept its use in testimony, and insurance policies are required by federal law to have a FRES of 45 or greater [72,76,91]. Applying the FRES to published editorials, the Readers Digest scores greater than 65, so it is easily understood by 12-year-old subjects, whereas the Harvard Law Review scores less than 49, so it is best understood by university graduates [46].…”

Chapter 7: Informed consent and xenotransplantation clinical trials

“…Examples of unfamiliar medical jargon include the terms clinical, placebo, protocol, and regimen. Examples of familiar versus unfamiliar words include using the term ''avoid'' rather than ''abstain,'' ''stop'' instead of ''discontinue'' and ''new use'' instead of ''new indication [21].'' The SACX draft document on informed consent contains an exemplary consent form that illustrates these and additional points about the form and content of a complete and understandable consent document in xenotransplantation research [19].…”

Informed consent in clinical research

“…Based on that report and recent discussions of informed consent in the ethics literature, it is clear that informed consent in xenotransplantation research embraces many issues and problems that arise in complex clinical research protocols generally [1,2]. This report, therefore, merits wide attention by clinical researchers in many areas.…”