• Home

  |

• About HHS

  |

• Newsroom

  |

• FAQs

  |

• Regulations

  |

• A-Z Index

The Institutional Review Board (IRB) is responsible for deciding whether child assent is required in proposed research activities. The IRB should require child assent unless it can be appropriately waived, or if the child is not capable of providing assent.

The regulations at 45 CFR 46.408(a) identify three types of circumstances where the IRB may determine that waiver of children’s assent is appropriate:

1. if the capability of some or all of the children is so limited that they cannot reasonably be consulted;
2. if 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.
3. if 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).

Last Reviewed: 01/20/2011

• How should child assent for research participation be documented?
• Do parental permission and child assent for research involving children have to occur at the same time or in any particular order?
• What happens when there is disagreement between a child and his/her parents about research participation?
• If by law a child is able to consent to treatment without parental permission, can they also consent to participate in research related to that treatment?
• What happens if a child reaches the legal age of consent while enrolled in a study?

• Research with Children