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Related Experiment Videos

Research consent forms: continued unreadability and increasing length.

M E LoVerde1, A V Prochazka, R L Byyny

  • 1Division of Internal Medicine, University of Colorado Health Sciences Center, Denver 80262.

Journal of General Internal Medicine
|September 1, 1989
PubMed
Summary
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Research consent forms remain difficult to read and understand, with average readability at a postgraduate level. Form length has also increased significantly, hindering comprehension for participants.

Area of Science:

  • Medical Ethics
  • Health Literacy
  • Informed Consent Research

Background:

  • Consent forms are critical for ethical research but are often lengthy and complex.
  • Poor readability and increasing length of consent forms can impede participant understanding.

Purpose of the Study:

  • To evaluate the readability and length of research consent forms.
  • To assess changes in consent form complexity over time.

Main Methods:

  • Analysis of 88 consecutive research consent forms from the Denver Veterans Administration Medical Center.
  • Assessment of reading levels using the Fry Readability Scale.
  • Measurement of form length in lines of text.

Main Results:

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  • The mean reading level required was 13.4 years (postgraduate level for 22% of passages).
  • The average form length was 84.6 lines, a 58% increase since 1982.
  • Readability has not improved since 1982.

    • Conclusions:

    • Consent forms remain largely incomprehensible due to difficult readability and increased length.
    • Investigators should prioritize brevity, plain English, and appropriate reading levels.
    • Training for investigators on obtaining valid consent is recommended.