Is child assent always required when research involves children?
No. The IRB is responsible for deciding whether child assent is required in proposed research activities. Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent (45 CFR 46.402(b)). Child assent is required, except in the following three circumstances described at 45 CFR 46.408(a): • the capability of some or all of the children is so limited that they cannot reasonably be consulted; • the intervention or procedure involved in the research holds out the prospect of direct benefit to the health or well-being of the children and is available only in the context of the research; • the research meets the same conditions as those for waiver or alteration of informed consent in research involving adults, as specified in the regulations at either 45 CFR 46.116(c) or 45 CFR 46.116(d).
