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Related Experiment Videos

Research participant information sheets are difficult to read.

Linda Franck1, Ira Winter

  • 1Institute of Child Health & Great Ormond Street Hospital for Children NHS Trust, Level 7, Old Building, Great Ormond Street, London WC1N 3JH, UK. linda.franck@ich.ucl.ac.uk

Bulletin of Medical Ethics
|April 9, 2005
PubMed
Summary

Parent information sheets for research studies involving children are too difficult to read. Improving the readability of these documents is crucial for informed consent and participant comprehension.

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Area of Science:

  • Medical Research Ethics
  • Health Literacy
  • Pediatric Clinical Trials

Background:

  • Effective communication is vital for informed consent in research.
  • Participant information sheets must be easily understandable for comprehension.
  • Ensuring accessibility of research information is a key ethical consideration.

Purpose of the Study:

  • To assess the readability of information sheets provided to parents in pediatric research.
  • To determine if current information sheets meet recommended readability standards.
  • To identify potential barriers to informed consent due to complex language.

Main Methods:

  • Analysis of 74 parent information sheets from research studies involving children.
  • Readability assessment using the Flesch Reading Ease (FRE) score.
Keywords:
Biomedical and Behavioral ResearchEmpirical Approach

Related Experiment Videos

  • Statistical analysis to evaluate the mean FRE and its variation across study characteristics.
  • Main Results:

    • The average Flesch Reading Ease score was 53.54, corresponding to a reading age of 15.88 years.
    • No significant difference in FRE was observed based on study characteristics.
    • Information sheets were consistently written at a reading level higher than recommended.

    Conclusions:

    • Parent information sheets for pediatric research are often written at a level that hinders comprehension.
    • Researchers must prioritize improving the readability of study documents.
    • Routine assessment of reading ease and targeted improvements are necessary for ethical research conduct.