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 8 th 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. “They also may not understand the protocol for drug regimens or follow-up visits. If they misinterpret that information, they may put themselves or their families in jeopardy.”

Tait and his research team studied 305 parents of children scheduled for minor elective surgical procedures. The parents received different versions of a consent form for a pediatric study that was performed in the past. Even though the children were not participating in the study described in the consent forms, parents were asked to consider the information as if their children really were participating in the old study.

Some of the parents received the standard consent form and some received a modified version. The modified form uses diagrams, simpler language, bolding, underlining, bullets and other tools to emphasize important aspects.

For instance, the standard form says, “Fifteen minutes before the end of the operation each patient will receive in a randomized fashion either the study medicine in one of two doses, or normal saline through the IV line.”

The modified form says, “2 out of 3 children will get the study medicine in one of two doses, and 1 out of 3 will get a placebo (not the medicine, but looks like the medicine).” It also includes a drawing with two children in the medicine group, and one child in the placebo group.

Later, parents were interviewed to determine their understanding of 11 required elements of consent, including the purpose of the study, risks, benefits, freedom to withdraw and more. The parents' understanding was significantly higher with the modified form, especially in such categories as risks and benefits.

When the parents were shown both forms, an overwhelming majority – 81 percent – preferred the modified form. These results show the importance of creating forms and other ways of presenting information that are simplified and easily understood by people of varying education levels, Tait says.

“It is imperative that consent forms be written at a level consistent with a layperson's reading ability and presented in a format that is readily understandable,” he says.

While Tait's study addressed forms related to parents of children participating in clinical trials, the findings could have broader implications, he adds. Whenever forms are used to provide patients with important information, Tait says, they should be written and presented in an easy-to-understand format.

“The same things that apply to research also apply to surgery and other varieties of medical consent,” he says. “Improving the format and readability could help people to grasp the risks and benefits of becoming involved in a clinical trial, or of undergoing a treatment or procedure.”

In addition to Tait, other authors on the paper were Terri Voepel-Lewis, MSN, RN, a clinical nurse specialist in anesthesiology; Shobha Malviya, M.D., associate professor in anesthesiology; and Sandra J. Philipson, MA, CAGS, an educational consultant from Chagrin Falls, Ohio.