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Emergency medicine research consent form readability assessment
1Department of Emergency Medicine, Tufts University School of Medicine, Boston, MA, USA.
Annals of Emergency Medicine
|April 1, 1997
Summary
Informed consent documents in emergency medicine research require a 10th-grade reading level. Complexity increases with subject risk, potentially hindering patient comprehension.
Area of Science:
- Medical Ethics
- Emergency Medicine Research
- Patient Comprehension
Background:
- Informed consent is crucial for ethical research participation.
- Ensuring patient understanding of complex medical information is a challenge.
- Emergency medicine research involves unique time constraints and patient populations.
Purpose of the Study:
- To assess the educational level required to comprehend informed consent documents in emergency medicine research.
- To evaluate the relationship between research risk and the complexity of consent forms.
Main Methods:
- Surveyed directors of 96 emergency medicine residency programs for consent forms.
- Analyzed 88 consent documents using readability software (RightWriter 5.0).
- Stratified forms by risk level and used ANOVA and Kruskal-Wallis tests for comparison.
Main Results:
- The average readability level required was 10th grade.
- Consent form length and complexity significantly increased with higher subject risk (P = .03).
- 88 informed consent documents were analyzed.
Conclusions:
- Informed consent documents in emergency medicine research may exceed the average patient's reading comprehension level.
- A direct correlation exists between the level of risk in a research protocol and the complexity of its associated consent form.
- Readability of consent forms needs improvement to ensure adequate patient understanding.
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