MONDAY, April 25, 2005 (HealthDay News) -- Many research consent forms are too difficult for many people to read and understand, says a University of Michigan Health System study.
"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," study author Alan Tait, a professor of anesthesiology and director of clinical research in the department of anesthesiology, said in a prepared statement.
"If they don't understand the forms, they may misinterpret the risks and benefits. 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 said.
He and his colleagues studied 305 parents of children scheduled for minor elective surgery. The parents were given different versions of a research consent form and asked to consider the information on the forms as if their children were actually taking part in a study.
Some of the parents received a standard consent form and others were given a modified version that included diagrams, simpler language, bolding, underlining and other features that emphasized important aspects of the consent form.
Researchers then interviewed the parents to assess their understanding of the consent forms. The parents who received the modified consent form had a much better understanding, especially in areas such as risks and benefits.
Later, all the parents were shown both forms, and 81 percent preferred the modified form.
"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," Tait said.
The study appears in the April issue of the Archives of Pediatrics and Adolescent Medicine.
More information
The U.S. National Cancer Institute has more about informed consent.
