When minors (less than age 18 years) will be enrolled in a study, permission (consent) must be obtained from the subject’s parent(s) or court appointed guardian(s).If the research involves greater than minimal risk but no direct benefit to the individual subject, consent must be obtained and documented in writing from either both parents or the legal guardian(s).
If minors age 7 years or older will be enrolled, the assent of the minor must be obtained if, in the judgment of the IRB, the children are capable of providing assent.
In determining whether children are capable of assenting, the IRB will 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 of direct benefit that 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 the assent requirement under circumstances in which consent may be waived in accord with federal regulations. Investigators must provide specific justification for waiver of assent, which must be reviewed and approved by the IRB.