Assent of Children in Research The IRBMED has developed an
assent template for researchers to use in developing an assent
document appropriate for children ages 10 to 14. It is available
at http://www.med.umich.edu/irbmed/ict.htm. Below are frequently
asked questions about assent. More information is available on
the IRBMED website at Why must IRBs and researchers consider
assent? Federal regulations require, “The IRB shall determine
that adequate provisions are made for soliciting the assent of
the children, when in the judgment of the IRB the children are
capable of providing assent.” The IRB must make the
determination for each protocol that includes children. The IRB
must require child assent unless it can be appropriately waived.
45 §46.408 & 21 § 50.55 What is assent? “Assent” means a child’s
affirmative agreement to participate in research. Mere failure
to object should not, absent affirmative agreement, be construed
as assent. This means the child must actively show his or her
willingness to participa