Informed consent for research: a study to evaluate readability and processability to effect change.

Abstract

BACKGROUND: Ninety million Americans are reported to have low literacy skills, and the problems associated with illiteracy permeate all areas of our society, including medical research. The purpose of this study was to determine the readability and comprehensibility of human research informed consent forms using established reading comprehension processes. Further, if comprehension problems were present in the forms, the study sought to identify the exact nature of these difficulties and identify specific areas where the forms could be rewritten to increase readability and understanding. METHODS: All human research informed consents approved by Hartford Hospital in 1993 were evaluated by a Readability and Processability Form (RPF) based on reading research, including the Fry Scale which yields an approximate grade reading level. The RPF assigned points to each of the 20 areas of analysis according to strict scoring criteria, and target scores were established by the authors in consultation with the hospital. RESULTS: Seventy-six informed consent forms were evaluated, and neither the Fry score or the RPF score was in the target range. Ninety-six percent of the forms were found to have readability levels higher than the target level (8th grade). The mean readability and processability score was 46, resulting in the classification, Minimally Adequate/Needs Improvement. (The target range was Good, 61-100.) A question by question analysis of each of the 20 checklist items on the RPF identified important aspects of text writing style that were scored as Unacceptable or Poor. CONCLUSIONS: The descriptive data indicates that there were problems with the readability of the informed consent documents studied. The prescriptive portion of this study provides researchers with information on specific areas where their forms need to be studied and rewritten. The comprehension problems found in this study may alert others to similar problems and may provide the basis for other institutional review boards (IRBs) to study their consent forms in order to ensure that the interests of both the patient and the researcher are protected and that the obtained consent is truly informed.