According to document 45 CFR 46.406, children are permitted to be research subjects if, There is no greater than minimal risk, or An intervention or procedure holds out the prospect of direct benefit for the individual subject, or a monitoring procedure is likely to contribute to the subject s well-being, or There is only a minor increase over minimal risk and the intervention or procedure is likely to yield generalizable knowledge about the subject s disorder or condition which is of vital importance for the understanding or amelioration of the subject s disorder or condition, and the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or educational situations. The IRB requires parental consent to be written. Generally speaking, the Federal government has interpreted this rule as requiring assent of children seven years of age or older, and encourages assent of younger children if there is reason to believe it would be meaningful. Mere failure to object should not, absent affirmative agreement, be construed as assent.
Affirmative agreement is necessary.
Under some circumstances written assent may be appropriate, but generally verbal assent will be sufficient. When a written form is used it should contain a simple explanation of the research project, including possible benefits, risks and safeguards. A copy of the assent form should be included in the proposal. There is no requirement of securing a child s assent if the research holds out a prospect of direct benefit that is important to the health or well-being of the child and is available only in the context of research. Saint Joseph's University.