Consent Forms Should Be More Readable
When children are part of a clinical trial, their parents must sign a document agreeing to the treatment and procedures used in the study. But what if they don't understand what they're being asked to sign?
Many consent forms are written above the recommended reading level and can be hard for many people to comprehend, according to a study by University of Michigan Medical School researchers, published in this month's issue of the journal Archives of Pediatrics and Adolescent Medicine.
"Typically, informed consent documents for research are written above the recommended 8th grade reading level, so they may be difficult for the average person to understand," says Alan Tait, Ph.D., professor of anesthesiology, director of clinical research in the U-M Health System's Department of Anesthesiology and lead author of the study.
"If they don't understand the forms, they may misinterpret the risks and benefits," he says.