How do research consent forms measure up?

Most IRBs endorse 6th-8th grade reading levels for consent forms

2003 Study of consent form readability

• 8% of research consents at US medical schools meet their own standards.
• Average reading level was 10.6 to college-level (depending on formula used)
  Paasche-Orlow, et al., New England Journal of Medicine, 348:8, Feb 20, 2003

Reading levels at Group Health Research Institute before PRISM

• Average grade level = 11.2
• 1/3 of consent forms at or above 12th-grade
• Only three of 70+ documents scored near 8th-grade