For this study, a patient must be able to voluntarily provide informed consent for him/herself. A guardian or family member cannot give consent on behalf of a patient. If a patient has a legal guardian or a conservator for medical decisions, they should be excluded from the study. In some cases, a physician or family member may inform you of inability to consent. Otherwise, you
should asses the patient’s capacity to understand and voluntarily consent as you discuss the study with them. If you believe the patient has a cognitive impairment or other impediment to providing genuine informed consent, the patient should not be enrolled in the study and this should be recorded in the screening log.