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Simplifying informed consent as a universal precaution.

Iris Z Feinberg1, Ajeet Gajra2, Lori Hetherington3

  • 1Department of Learning Sciences, College of Education and Human Development, Georgia State University, Atlanta, GA, USA. Ifeinberg2@gsu.edu.

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Simplified informed consent documents (ICDs) improve patient understanding in clinical research. This plain language approach benefits all adults, regardless of reading ability, aiding trial participation.

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Area of Science:

  • Health Literacy
  • Clinical Research Participation
  • Patient Comprehension

Background:

  • Low health literacy affects 1 in 5 US adults, hindering understanding of informed consent documents (ICDs).
  • Simplified language in ICDs can improve understandability and inclusivity for diverse research populations.
  • Evaluating simplified ICDs is crucial for enhancing clinical trial participation.

Purpose of the Study:

  • To assess the understandability of a simplified ICD.
  • To determine if factors like reading skills and working memory influence the effectiveness of simplified ICDs.

Main Methods:

  • An online survey was conducted with 192 adults aged 18-77 in Georgia.
  • Participants completed a test using a simplified ICD.
  • Statistical models were used to analyze comprehension and potential moderating factors.

Main Results:

  • Participants demonstrated significantly better performance with the simplified ICD.
  • Individual differences (age, sex, race, urbanicity, cognitive measures) did not moderate the simplification's effect.
  • Model fit was not significantly improved by including interaction terms.

Conclusions:

  • Simplified language and syntax in ICDs act as a universal precaution, reducing cognitive load for all adults.
  • Enhanced ICD understandability can potentially improve clinical trial enrollment targets.
  • Health literacy and plain language guidelines are effective in making research accessible.