In some cases, parents may agree to a child’s participation in research with the expectation that the child, once approached, may not want to participate and that the child’s wishes will be accepted. In other situations, parents and children may negotiate decisions about research participation, with the views of adolescents tending to have more weight. Sometimes, parents may expect their wishes for the child to participate in research to prevail over a child’s wish not to participate in research, especially when the research has the prospect of benefiting an ill child. Federal regulations governing research involving children appropriately do not require the child’s assent when research offers the prospect of an important direct benefit that is available only in the context of the research” (45 CFR 46.408(a); 21 CFR 50.55 (c)(2)). Investigators should avoid suggesting to children that they can make the participation decision when their parents can override their wishes.
Nonetheless, even when it can be overridden, a child’s dissent should not be regarded as simply inferior to the parents’ views and decisions but, rather, should be viewed as reflecting a different and still important point of view. Investigators or others involved in the assent process should work with parents to help them understand children’s views and treat them respectfully. It will usually be better for all involved if agreement between parent and child—especially an older child or adolescent—can be achieved. This may involve a developmentally variable process of negotiation. As discussed earlier, it may sometimes be reasonable—as part of a respectful and noncoercive assent process with parental agreement—for investigators to come back to a child who says “no” to see whether he or she may feel differently later.
In rare instances, understanding and respect may lead an investigator or clinician involved with the child’s care to advocate—with great sensitivity to the family’s wishes and values—on behalf of a dissenting older child or adolescent when the assent process reveals compelling reasons for encouraging parents to consider accepting rather than overriding the dissent. One such situation may arise when a mature adolescent who has a grave medical problem that has been unresponsive to treatment asks not to be subjected to a burdensome investigative procedure that offers at most a remote prospect of meaningful benefit. When parents are desperate to do something or fear feeling guilty in the future if they refuse proposed interventions, they may find it difficult to fully consider the burdens that research participation is likely to impose on their child.
When research does not have the prospect of direct benefit to the child, the committee interprets the regulatory requirements that “adequate provisions are made to solicit the child’s assent” to mean that the child’s dissent overrides parental permission. Investigators should be alert to nonverbal indications of children’s wishes about research participation, particularly