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Readability standards for informed-consent forms as compared with actual readability
Michael K Paasche-Orlow1, Holly A Taylor, Frederick L Brancati
1Department of Medicine, Johns Hopkins University, Baltimore, USA. mpaasche@jhmi.edu
The New England Journal of Medicine
|February 21, 2003
Summary
Institutional Review Boards (IRBs) often provide informed consent documents that are too difficult for patients to read, falling below their own standards. Federal oversight appears to improve the readability of these crucial research documents.
Area of Science:
- Medical Ethics
- Health Literacy
- Clinical Research Administration
Background:
- Institutional Review Boards (IRBs) are responsible for protecting research participants, particularly those with limited literacy.
- However, IRBs may inadvertently issue informed consent forms that are difficult to comprehend.
- This study investigates whether IRB-provided text meets their own readability standards.
Purpose of the Study:
- To determine if informed consent form text provided by IRBs meets their stated readability standards.
- To assess the influence of research activity, local literacy rates, and federal oversight on the readability of IRB-provided text.
Main Methods:
- A cross-sectional study surveyed 114 U.S. medical school websites for IRB readability standards and consent form templates.
- Readability was assessed using the Flesch-Kincaid scale (grade level, 0-12).
- Data on research activity, literacy rates, and federal oversight were collected from public sources.
Main Results:
- The average readability score of IRB-provided text was a 10.6 grade level, exceeding stated standards by 2.8 grade levels.
- Readability standards were found on 54% of websites, ranging from 5th to 10th grade.
- Readability was not linked to research funding or local literacy rates, but federal oversight was associated with better readability (10.2 vs. 10.9, P=0.005).
Conclusions:
- IRBs frequently issue informed consent text that does not meet their own established readability benchmarks.
- Federal oversight is correlated with improved readability of informed consent documents.
- Enhancing the clarity of consent forms is crucial for protecting participant comprehension and autonomy.