- Subject of legal age, parent or legal guardian, as required, has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form, after the nature of the study has been explained and the subject of legal age, subject's parent, or legal guardian, as required, has had the opportunity to ask questions. Subjects will be included in all discussions, and if required, their signature on an assent form will be obtained.