Cluster 603: caregiver patient primary identified family friend caregivers person willing parent Cluster 1019: providing capable consent informed procedures written complying patient parent guardian Cluster 1057: guardian legal consent informed patient parent able provide written sign Cluster 1059: guardian informed explained consent copy understood patient signed given procurement Cluster 1447: legal incapacity capacity limited subject providing patients granted authorization guardian Cluster 1905: parent guardian assent consent informed written patient legal signed minor Cluster 2339: guardian unwillingness legal representative research inability participant written consent informed