Research projects involving children as participants typically require the written permission of one or both parents [see 45 CFR 46.408(b)] or guardian in accordance with the informed consent procedures delineated in the informed consent requirements (Section J.1). In addition to parental or guardian permission for a child to participate in a research study, the assent of the child must be solicited, assuming the child is capable of providing assent. To make this judgment, the IRB will consider the age, maturity, and psychological state of the targeted child population. Even if the children are capable of providing assent, the IRB may waive the assent requirement when consent requirements are waived (see CFR 46.116).
Typically, parental or guardian permission must be documented. However, a PI may request a waiver of the documentation of informed consent based on 45 CFR 46.117(c) (see above noted exceptions for more details). Additionally, the IRB may determine that parental or guardian permission is not a reasonable requirement to protect participants (e.g., neglected or abused children) and it may waive the consent requirements, provided that an appropriate mechanism for protecting the children who participate as participants in the research is substituted and the waiver is not inconsistent with federal, state, or local law [45 CFR 46.408(c)].