According to the Federal regulations on the Protection of Participants, for research falling under categories a. and b. above, the permission of one parent is sufficient. Permission from both parents is required for category c. above unless one parent is deceased, unknown, incompetent or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. The AA-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, though in many cases 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. In approval of research involving prisoners, the judgment of the Secretary of Health and Human Services must be sought and confirmation be given that the topic of the research is included in the list entered below.