In addition to parental permission, federal regulations require that the IRB must determine whether adequate provisions are made for soliciting the assent of a child to participate in research when the child is capable of providing assent [45 CFR 46.408]. Assent is defined as “a child’s affirmative agreement to participate in research.” However, the mere absence of an objection by the child should not be construed as assent.

The regulations do not specify an age at which assent is required. The UT Southwestern IRB requires written documentation of assent for participation of subjects ages 10 – 17 unless waived as explained below. However, generally speaking, investigators should seek verbal assent from children as appropriate to their age, maturity and psychological state. The assent process fosters an element of understanding, cooperation and feeling of inclusion on the part of the child while demonstrating the investigator’s respect for the rights and dignity of the child in the context of research.

In certain circumstances, the IRB may waive the requirement to obtain the assent of a child subject. For example:

• The capacity of some or all of the children to be studied is so limited that they cannot reasonably be consulted; or
• The research offers the prospect of a direct benefit that is important to the health or well-being of the child and is available only in the context of the research.
Here, the parents’ right to make medical decisions for their child may come into conflict with the child’s right to give or withhold assent. In this situation, the IRB can waive the requirement for assent, but the child should be appropriately informed about the study.

The IRB may grant a waiver of assent on any study involving children when the above conditions are met. In addition to making a determination of risk and benefit as required by Subpart D (“Special Findings”), the IRB will determine whether a waiver of assent is appropriate for the study. The decision of the IRB regarding waiver of assent will depend on the specifics of the study. For example, approval of a waiver of assent would likely be indicated for a trial of primary induction therapy for a new malignancy where there is a real prospect of direct benefit to subjects. However, in some Phase I studies for recurrent malignancies, where direct benefit is not probable, the IRB should consider whether it is appropriate to allow the child to refuse participation. If a waiver is not considered justifiable by the IRB, assent would be required.

Investigators may request a waiver of assent in their IRB application. When requesting a waiver of assent, justification and measures to protect the child should be described.

Occasionally, in studies for which the IRB has required assent by minor subjects, an investigator may find that an individual child is incapable of providing assent due to illness or cognitive status. In this case, the investigator should obtain permission from the child’s parent(s)/guardian and should record on the informed consent document the reason the child was unable to assent. In keeping with the ethical principals of justice and respect for persons, reasonable efforts should be made to conduct research using children capable of assent before enrolling those unable to assent.