Consent forms: how to determine and improve their readability

Oncol Nurs Forum. 1992 Nov-Dec;19(10):1523-8.


This study investigated the reading level estimates of cancer clinical trial consent forms from actively accruing studies at the Medicine Branch and the Clinical Pharmacology Branch of the National Cancer Institute. Forty-four consent forms were analyzed using the SMOG formula. Readability levels ranged from grade 12 to grade 17.5 (mean = 14.3). The conclusion was that these consent forms were written above most subjects' reading levels. The usefulness of consent forms could be improved significantly by using readability formulas, applying rewriting techniques, and being aware of subjects' comprehension levels. This paper suggests a number of strategies that nurses can use to enhance comprehension of the information contained in informed consent documents.

MeSH terms

  • Clinical Trials as Topic*
  • Comprehension*
  • Consent Forms*
  • Evaluation Studies as Topic
  • Forms and Records Control
  • Humans
  • Informed Consent*
  • National Institutes of Health (U.S.)
  • Neoplasms / nursing*
  • Neoplasms / therapy
  • Nursing Assessment
  • Oncology Nursing / methods
  • Patient Education as Topic
  • Reading*
  • Research Subjects*
  • United States