Clinical Research Nurses (CRNs) are involved in informed consent in a variety of capacities: conduct the informed consent discussion, obtain a participant's consent, and continually reinforce the informed consent process. As part of the CRN's advocacy role, the CRN is responsible for verifying that the participant understands what they are agreeing to. When assessing a participant's understanding, it is also important to recognize various situations where their understanding may be compromised. This webinar discusses mental capacity in the informed consent process, the impact of health literacy and regulations on the informed consent process, and implications for the CRN.