Readability of the terms of consent in clinical research

Abstract

The aim of this study is to analyze the readability of two Informed Consent Forms (ICF) used for the participation in a clinical trial and the correlation of the degree of difficulty with the education level of the participants. The two ICF were analyzed using the Flesch Reading Ease (FRE) and the Flesch-Kincaid (FLK) readability tests. Through analysis by the Flesch score the ICF for selection of volunteers and participation in a clinical trial had, respectively, a value of 61 and 56, while the FLK values were 6.59 and 8.4 respectively. The ICF for selection and participation in the clinical trial was inadequate for 49% and 72% of these participants. Those two ICF used for participation in clinical trials were not suitable for the education of the majority of its participants.