Do informed consent documents for chiropractic clinical research studies meet readability level recommendations and...

Area of Science:

• Clinical Research Ethics
• Health Literacy
• Patient Education

Background:

• Informed Consent Documents (ICDs) are legally required to educate participants about research.
• US law mandates specific content elements and understandable language in ICDs.
• Readability and content completeness of ICDs are crucial for ethical research conduct.

Purpose of the Study:

• To evaluate the readability of ICDs used in chiropractic randomized controlled trials.
• To assess whether these ICDs contain all 13 legally required content elements.
• To identify potential gaps in participant understanding and legal compliance.

Main Methods:

• Analyzed 13 ICDs from four chiropractic colleges using the Flesch-Kincaid readability test.
• Assigned a grade-level readability score based on the average of three text blocks.
• Assessed content completeness using a 13-element checklist.

Main Results:

• The mean Flesch-Kincaid grade level was 10.8, significantly above the US average.
• Readability scores ranged from 7.2 to 14.0, indicating varying levels of complexity.
• Content completeness varied, with one document containing only nine elements and five containing all 13.

Conclusions:

• Chiropractic clinical research ICDs often exhibit poor readability, exceeding national averages.
• Incomplete content in some ICDs raises concerns about fully informing participants.
• Potential non-compliance with federal requirements and variability in risk disclosure were noted.