General
Research personnel will obtain informed consent from the infant’s parent or legal guardian (legally authorized representative). If there are any concerns regarding the cognitive status of the mother, the site PI or designee will be consulted. If the infant’s mother is cognitively impaired and is unable to provide informed consent to the research study, then an alternative legal guardian may be approached for consent per local guidelines. Sites will follow location-specific requirements for enrollment of wards of the state. If legal guardianship changes, the new legal guardian would be contacted to obtain consent for the study.