查看文章

Background. Consent forms are required in most biomedical research involving human subjects. In recent years, a number of studies from different disciplines have reported problems related to consent form readability.

Methods. We analyzed 284 consent forms submitted to and approved by five institutional review boards (IRBs)(schools of Medicine, Nursing, Academic Affairs, Dentistry, and Public Health) at one university and one IRB at another. We examined consent form readability scores and factors that might relate to readability.

Results. The average reading level of all consent forms was high: 12.2, which corresponds roughly to a 12th-grade reading level. Less than 10% of all consent forms were written at a 10th grade reading level or below. Thirty-two percent of all consent forms had no evidence of revisions, and less than 2% of consent forms were revised more than once. Readability scores were not related …