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Related Experiment Videos

Consent form readability in university-sponsored research

A O Goldstein1, P Frasier, P Curtis

  • 1Department of Family Medicine, University of North Carolina, Institute for the Generalist Physician, Chapel Hill, USA.

The Journal of Family Practice
|June 1, 1996
PubMed
Summary
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Most biomedical research consent forms are difficult to read, with an average 12th-grade reading level. Improving consent form readability is crucial for ethical research and participant understanding.

Area of Science:

  • Biomedical Research Ethics
  • Health Literacy
  • Scientific Communication

Background:

  • Informed consent is essential for human subject research.
  • Numerous studies indicate challenges with consent form readability across disciplines.

Purpose of the Study:

  • To assess the readability of consent forms used in biomedical research.
  • To identify factors influencing consent form readability.

Main Methods:

  • Analysis of 284 consent forms from five Institutional Review Boards (IRBs) at two universities.
  • Examination of readability scores and related factors.

Main Results:

  • Average reading level was 12.2 (12th grade); less than 10% were at 10th grade or below.
Keywords:
Biomedical and Behavioral ResearchEmpirical ApproachMichigan State University in EscanabaUniversity of North Carolina at Chapel Hill

Related Experiment Videos

  • 32% of forms showed no revisions; less than 2% were revised more than once.
  • Readability was not linked to IRB type, revision status, study year, or university.

    • Conclusions:

    • Poor consent form readability is prevalent in university research.
    • IRBs should mandate readability checks before proposal submission to enhance participant comprehension.