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

Background: 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.

Aims: We evaluated whether a novel informed consent process was more effective than current practice at helping adults with ID understand key elements of research.

Methods And Procedures: 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.

Outcomes And Results: The pilot found encouraging evidence for the efficacy and feasibility of the ITP. The two novel ITP approaches were both superior to current practice.

Conclusions And Implications: 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.