Response: One parent even if the other parent is alive, known, competent, reasonably available, and shares legal responsibility for the care and custody of the child. Both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. Parent permission will not be obtained. A waiver of parent permission is being requested. NOTE: The requirement for parent permission is a protocol-specific determination made by the IRB based on the risk level of the research. For guidance, review the Children (HRP-416).” “CHECKLIST: Describe whether permission will be obtained from individuals other than parents, and if so, who will be allowed to provide permission. Describe your procedure for determining an individual’s authority to consent to the child’s general medical care. Response: Indicate whether assent will be obtained from all, some, or none of the children. If assent will be obtained from some children, indicate children will be required to assent. Response: When assent of children is obtained, describe how it will be documented. Response: Waiver or Alteration of Consent Process Consent will not be obtained, required information will not be disclosed, or the research involves deception. N/A: A waiver or alteration of consent is not being requested. If the research involves a waiver or alteration of the consent process, please review the Waiver or Alteration of Consent Process “CHECKLIST: to ensure that you have provided sufficient information for the IRB to make the determination that a waiver or alteration can be granted. NOTE: For records review studies, the first set of criteria on the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-410)” applies. Response:
Response: One parent even if the other parent is alive, known, competent, reasonably available, and shares legal responsibility for the care and custody of the child. Both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. Parent permission will not be obtained. A waiver of parent permission is being requested. NOTE: The requirement for parent permission is a protocol-specific determination made by the IRB based on the risk level of the research. For guidance, review the “CHECKLIST: Children (HRP-416).” Describe whether permission will be obtained from individuals other than parents, and if so, who will be allowed to provide permission. Describe your procedure for determining an individual’s authority to consent to the child’s general medical care. Response: Indicate whether assent will be obtained from all, some, or none of the children. If assent will be obtained from some children, indicate children will be required to assent. Response: When assent of children is obtained, describe how it will be documented. Response: Waiver or Alteration of Consent Process Consent will not be obtained, required information will not be disclosed, or the research involves deception. N/A: A waiver or alteration of consent is not being requested. If the research involves a waiver or alteration of the consent process, please review the “CHECKLIST: Waiver or Alteration of Consent Process to ensure that you have provided sufficient information for the IRB to make the determination that a waiver or alteration can be granted. NOTE: For records review studies, the first set of criteria on the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-410)” applies. Response: