Related Experiment Videos
Informed consent for medical research: common discrepancies and readability
L J White1, J S Jones, C W Felton
1Akron General Medical Center, OH, USA.
Summary
Informed consent forms (ICFs) often have discrepancies and are written at a 14th-grade reading level, making them difficult for patients to understand. Researchers face challenges in creating ICFs that meet federal requirements and are accessible to the general population.
Area of Science:
- Medical research ethics
- Regulatory compliance in healthcare
Background:
- Informed consent is crucial for ethical medical research.
- Institutional Review Boards (IRBs) oversee research involving human subjects.
- Federal regulations mandate specific content for informed consent forms (ICFs).
Purpose of the Study:
- To identify common content discrepancies in ICFs submitted to IRBs.
- To determine the average reading grade level of ICFs.
- To assess the comprehensibility of ICFs for the general population.
Main Methods:
- Retrospective analysis of 82 ICFs from three hospitals over one year.
- Evaluation of ICF content against 23 federal regulatory requirements.
- Computerized readability analysis using two comprehension indexes.
Main Results:
- 22% of ICFs were incomplete, missing at least nine federal requirements.
- The average ICF had 4.7 discrepancies.
- The mean Flesch reading grade level was 13.8, indicating poor readability for the general adult population.
Conclusions:
- Researchers struggle to balance federal requirements with accessible language in ICFs.
- Many ICFs are not comprehensible to the average person, potentially hindering informed consent.
- Improving ICF readability is essential for ethical research and patient understanding.