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Education level, primary language, and comprehension of the informed consent process
Peter E Breese1, William J Burman, Stefan Goldberg
1Denver Public Health (USA).
Educational level significantly impacts informed consent comprehension and satisfaction. Lower education levels correlate with markedly reduced understanding and satisfaction in the informed consent process for diverse participants.
Area of Science:
- Clinical Research
- Health Disparities
- Patient Education
Background:
- Informed consent is crucial for ethical clinical research.
- Diverse populations may face unique challenges in understanding informed consent.
- Previous research has not fully explored the impact of educational background on this process.
Purpose of the Study:
- To investigate how individuals from diverse educational and linguistic backgrounds experience the informed consent process.
- To identify factors associated with comprehension and satisfaction.
Main Methods:
- Survey of 100 adults recently enrolled in a study requiring written informed consent.
- Inclusion of participants with varied educational levels and primary languages (English, Spanish, Vietnamese).
- Analysis of comprehension and satisfaction scores, with a focus on educational level via multivariate analysis.
Main Results:
- Median comprehension score was 62% (IQR 50-76%); median satisfaction score was 86% (IQR 71-100%).
- Lower educational levels were significantly associated with lower comprehension and satisfaction (p < 0.001).
- Participants with less than a high school education demonstrated markedly lower scores.
Conclusions:
- Educational attainment is a critical determinant of informed consent comprehension and satisfaction.
- Findings highlight potential disparities in the informed consent process for less educated individuals.
- Strategies to improve informed consent for diverse educational backgrounds are warranted.
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