Evaluating an informed consent process designed to improve inclusion of adults with intellectual disability in research.

Adults with intellectual disability (ID) are both underrepresented in research and enrolled in studies they may not understand. Instead of facilitating research engagement, the informed consent process often fails to elucidate its essential elements. We evaluated whether a novel informed consent process was more effective than current practice at helping adults with ID understand key elements of research. 21 adults with ID completed a novel iterative teaching process (ITP) for teaching and assessing informed consent. The ITP was used to compare the baseline (Conventional) approach to an Easy Read and a Conversational approach. Participants were asked a series of questions to assess their attitudes toward, and their comprehension of, the materials. The pilot found encouraging evidence for the efficacy and feasibility of the ITP. The two novel ITP approaches were both superior to current practice. This project contributes to a growing literature by introducing a process for teaching and evaluating informed consent. Results indicate that comprehension of informed consent materials can be taught to, and learned by, adults with ID with proper accommodations. • Current informed consent practices can present barriers to research participation. • Novel consent processes were used for teaching and evaluating capacity to consent. • Novel approaches were both superior and preferred to current practice. • Adults with intellectual disability can be taught informed consent concepts. • Improved comprehension of consent process lowers barriers to inclusion in research. [ABSTRACT FROM AUTHOR]