A. The investigator must obtain the child's assent to participate in the proposed research. If the investigator finds a child or group of children incapable of giving assent, the investigator must request a waiver of this requirement and provide justification of this waiver in the Application for Approval of Activity Involving the Use of Human Subjects (UCSB/ORDA Form 112f).
B. The investigator must obtain permission from the parent/guardian of the child and for research that involves more than minimal risk, permission must be obtained from both parents. Exceptions to this requirement pertain only when one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the child.
C. The requirement for obtaining permission from a parent may be waived if the subjects are not protected by this requirement (for example, neglected or abused children), provided that the investigator documents for the HSC that an alternative form of protection has been sought (e.g. permission from a legally authorized representative).