Related Experiment Videos
Readability of pediatric biomedical research informed consent forms.
K J Tarnowski1, D M Allen, C Mayhall
1Department of Pediatrics, Case Western Reserve University, Cleveland, OH 44109.
Pediatrics
|January 1, 1990
Summary
Pediatric informed consent forms are difficult to read, written at a college graduate level. This compromises the informed consent process in pediatric biomedical research, highlighting a critical need for improved readability.
Area of Science:
- Biomedical Ethics
- Health Literacy
- Pediatric Research
Background:
- Informed consent is crucial for ethical biomedical research.
- Regulations require easily understandable study information for participants.
- Previous studies found adult consent forms lack readability.
Purpose of the Study:
- To assess the readability of pediatric informed consent forms.
- To determine if form length or specific sections impact comprehension.
- To address the gap in data regarding pediatric consent form readability.
Main Methods:
- Readability analyses were performed on 238 pediatric informed consent forms.
- Data were collected over a 10-year period from a children's hospital.
- Fry grade equivalent and Flesch Reading Ease methods were used.
Main Results:
- Pediatric consent forms were written at a college graduate reading level.
- Increased document length did not correlate with improved readability.
- Specific sections within the forms exhibited varying reading difficulties.
Conclusions:
- The readability of pediatric informed consent forms is compromised.
- Findings align with adult consent form studies, indicating a systemic issue.
- Readability must be improved to ensure the integrity of the informed consent process.