Assent Age Ranges

Research involving children requires that adequate provisions are made for soliciting the assent of the child and the permission of their parents or guardians consistent with the standards described in 45 CFR 46.408.

Children who reach the age of majority while participating in a study must be consented if continuing interventions or interactions are planned (including collection or analysis of identifiable private information), as described in 45 CFR 46.116. The IRB may grant a waiver of consent under 45 CFR 46.116 (e), if it finds that required conditions are met, but must document its decision and rationale for doing so.  For considerations of age for obtaining and documenting assent, please refer to Assent Age Ranges Guidance.