The influence of health literacy, demographic and socioeconomic factors, and time of consideration on the comprehension of content in a consent form for medical research

The informed consent form (ICF) is the primary tool used by clinical research teams to provide information to and document voluntary consent. The technical nature of the ICF document poses a threat to participant comprehension and compromises the researchers' ethical duty to achieve an effective informed consent process. The purpose of this research was to investigate the influence of individual and consent form process factors on the ICF content comprehension. While literature lacks theoretical grounding, this study proposed an exploratory conceptual framework based on literacy and ethical concepts. The research question investigated how the amount of time participants spend on ICF content, health literacy levels, and demographic and socioeconomic factors affected comprehension. Participants completed a cross-sectional online survey, read an ICF, and answered content questions. Data analyses on 160 English-speaking participants included descriptive statistics comparing 108 participants that provided full data and partial responders (n =52). Multivariate hypotheses testing using linear correlations and multiple regression analyses were performed on the analytical sample of 108 using Predictive Analytic Software. A moderate but significant relationship existed between health literacy and comprehension scores. Age, high school education, and college education also had a significant association with ICF comprehension. The social implications from this study include contributions to the advancement of the content, comprehension and necessary time allotted to ensure an effective informed consent process that meets ethical guidelines. The findings could contribute to increased participant safety and improved public trust in clinical research.