Consent
Only appropriately trained staff conduct informed consent. Information is provided to the mother in written, verbal and pictorial formats, with language translation where requested. The study is explained to expectant mothers face to face, and they are provided with sufficient time to ask questions, discuss and consider participation of themselves and their child with relevant others and obtain further study details prior to signing and dating the informed consent form. The consent process includes explanations of all elements of consent according to GCP, the Declaration of Helsinki, National Health and Medical Research Council (NHMRC) requirements and according to local requests to ensure cultural safety (as recommended by the First Nations Child Health Reference Group.Additional consent is sought from parents or guardians to use participant data and biological specimens for future research relating to child health respiratory studies. Options to refuse each or all requests are provided. Participants are also asked if they would like to be contacted about future research studies.