Reports From the Field: Consent form language difficult to understand
The average consent form for clinical trial volunteers is written at the 10th-grade reading level, while an estimated one in two American adults reads at or below an eighth-grade level, a new study has concluded.1
Researchers who studied consent forms at 114 U.S. medical schools found that the sample text for consent forms generally fails to meet the schools’ own standards for reading comprehension.
The investigators recommended using language comprehended by someone on a fourth- to sixth-grade reading level to increase the comprehension among participants in clinical trials.
"Alternative methods of obtaining informed consent, such as multimedia presentations, also may be beneficial. Every time subjects come in, you have to make sure they understand what is going on," says Michael K. Paasche-Orlow, MD, MPH, lead author of the study.
Reference
1. Paasche-Orlow MK, et al. Readability standards for informed-consent forms vs. actual readability. N Eng J Med 2003; 348:721-726.
The average consent form for clinical trial volunteers is written at the 10th-grade reading level, while an estimated one in two American adults reads at or below an eighth-grade level, a new study has concluded.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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