Abstract

Background: One of the ethical imperatives for a valid consent process in clinical medication trials is that the process be guided by and recorded in an informed consent document (ICD). Concerns have been expressed, however, about readability and participant understanding of ICDs, which are often 10–20 pages long. Objective measures of readability and understanding have been used to support these concerns in several articles, but surprisingly the voice of trial participants on ICDs has not been heard in previous studies. Hence, this study compares participants' subjective views on readability and their understanding of ICDs with those ICDs' objective readability scores. It also evaluates whether family, friends, and additional aids would foster better understanding of the ICD. Methods: Sixty current trial participants rated the readability and their understanding of deidentified standard ICDs. These had been sourced from two multicenter international Phase III trials on medication for diabetes mellitus and cancer. Results: Less than 10% of participants considered the ICDs difficult to read or difficult to understand in spite of objective readability scores at levels of about 12th grade education, but about a quarter considered the ICDs to be too technical. Participants gave mixed responses about friends or family members helping or the need for videos, pictures, additional reading material, and frequently answered questions (FAQ) sheets as an aid to their understanding. Conclusions: These findings suggest individual clinical trial participants should be engaged on their views of an ICD, for doing so is part of informed consent as a process rather than consent being merely focused on written information. Such participant-specific engagement should guide whether family and friends, videos, pictures, additional reading material, and FAQ sheets would be of assistance in improving understanding.