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Informed consent for research: a study to evaluate readability and processability to effect change

S J Philipson1, M A Doyle, S G Gabram

  • 1Reading and Language Arts Center, University of Connecticut, USA.

Journal of Investigative Medicine : the Official Publication of the American Federation for Clinical Research
|October 1, 1995
PubMed
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Most human research informed consent forms have poor readability, exceeding an 8th-grade level. This study identified specific areas for improvement to ensure patient comprehension and truly informed consent.

Area of Science:

  • Medical Research Ethics
  • Health Literacy
  • Patient Comprehension

Background:

  • Low literacy skills affect 90 million Americans, impacting all societal areas, including medical research.
  • Illiteracy poses significant challenges to understanding critical health information.

Purpose of the Study:

  • To assess the readability and comprehensibility of human research informed consent forms.
  • To identify specific difficulties in consent forms and suggest improvements for clarity.

Main Methods:

  • Evaluated 76 informed consent forms using the Readability and Processability Form (RPF) and Fry Scale.
  • Assessed 20 areas of analysis with strict scoring criteria against established target scores.

Main Results:

Keywords:
Biomedical and Behavioral ResearchEmpirical ApproachHartford Hospital (CT)

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  • 96% of forms exceeded the target 8th-grade reading level.
  • The average readability and processability score was 46 (Minimally Adequate/Needs Improvement).
  • Analysis revealed unacceptable or poor writing style in key areas of the forms.

Conclusions:

  • Informed consent documents studied exhibit significant readability problems.
  • Findings offer researchers specific areas for rewriting forms to enhance understanding.
  • Identified comprehension issues may prompt IRBs to review consent forms for improved patient protection and informed consent.