Adequate provisions

uate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determiningare capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect ofthat is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive thecircumstances in which consent may be waived in accord with §46.116 of Subpart A. (b) In addition to theother applicable sections of this subpart, the IRB shall determine, in accordance with and to the extent