Readability of Pediatric Biomedical Research Informed Consent Forms

Abstract

Informed consent forms are used in biomedical research as a mechanism to convey study information to potential subjects so that they may arrive at a decision concerning their willingness to participate. Although the Department of Health and Human Services Regulations for the Protection of Human Subjects require the presentation of specific study information at a level that is easily understood, according to research concerning adult biomedical consent forms, the typical form is not readily comprehensible. Unfortunately, no data exist concerning the readability of informed consent forms that are used in the context of pediatric biomedical research. In the present study, readability analyses were conducted on a large sample (N = 238) of pediatric biomedical informed consent forms obtained during a 10-year period from a large midwestern children's hospital. For the entire sample, results derived from two readability estimates (Fry grade equivalent and Flesch Reading Ease methods) indicated that the consent forms were written at the college graduate level. Although there was a linear increase in the length of the consent document during the 10-year period evaluated, expanded length was not associated with improved readability. According to analyses, a differential pattern of reading difficulty was associated with specific sections of the informed consent document. Findings are highly consistent with those from studies of adult biomedical consent forms and document that the purpose of the informed consent form is being compromised, in part, by a readability factor. Suggestions for solving this critical problem are advanced.