Study Finds IRBs Make Consent Forms Harder to Read

In "Human-Subjects Research: Trial and Error," (Nature, 2 August 2007), Heidi Ledford writes:

When [physician William] Burman, of the University of Colorado in Denver, joined in two studies run by the Tuberculosis Trials Consortium, he knew that the consent forms needed to cater to people with an eighth-grade reading level (comprehensible to an educated 13-year-old). The trials involved multiple institutions, and the forms were sent to 39 institutional review boards (IRBs) — committees designed to determine whether a proposed experiment is ethically sound. The final approvals came in 346 days later, but what the IRBs sent back, Burman found disturbing.

"The consent forms were longer. The language was more complex," Burman says. "And errors were inserted at a surprising frequency." In one case, a potential negative side effect of the treatment had been accidentally edited out. Burman responded to the problem as any researcher would: he studied it. He had an independent panel review the changes. The reviewers found that 85% of the changes did not affect the meaning of the consent forms, but that the average reading level had jumped from that of an eighth grader to that of a twelfth grader (around 17 years old)1. His results confirmed something he'd suspected for some time. "I started to think about what was happening and it just seemed like the system was flawed." It was time to change the system.

Though the article (and the accompanying editorial, "Board Games," does not mention non-biomedical research, it does highlight the problem of relying on local IRBs, which are essentially committees of amateurs, to handle specialized tasks like drafting consent forms and determining procedures for confidentiality. See In Search of Expertise.