Can parental or guardian permission for research involving children be waived?
Yes, under certain circumstances. An IRB may waive the requirements for obtaining parental or guardian permission if either of the following two conditions is met: • The IRB makes and documents the required findings under either 45 CFR 46.116(c) or (d); or • The IRB determines that a research protocol is designed to study conditions in children or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), and the following 2 additional criteria are also met: • An appropriate mechanism is in place to protect the children, and • The waiver is not inconsistent with federal, state, or local law (45 CFR 46.408(c)). The choice of an appropriate substitute mechanism (for example, appointing a child advocate or an assent monitor) for protecting children participating in research would depend on the nature and purpose of the activities described in the protocol, the risk and anticipated bene
