Child Assent Revisited

David Wendler and Seema Shah (2003) suggest the age of 14 as the threshold for requiring assent for nontherapeutic research. I shall offer three reasons why 14 is too high a threshold.

The first and perhaps most important reason is that U.S. federal regulations already have built-in protections for the child, and thus researchers need not rely on a child's own ability to assess risk and distress. The regulations stipulate that research that poses anything greater than minimal risk is allowable under only very special circumstances: if it is of vital importance to understanding a disorder or condition the child suffers from and will lead to generalizable knowledge about that condition, even if it is not expected to be of direct benefit to the child. Even then the risk or discomfort must be roughly the same as experiences the child might have in his or her daily life. For children not suffering from some disorder, only procedures involving minimal risks may be used. Thus, anything the child will be asked to assent to has already been screened by an institutional review board (IRB) to ensure it poses only minimal risk (Forman and Ladd 1996).In addition, of course, parental permission is required, so parents also screen protocols before children may participate.

Concerning the level of distress a child might feel in even minimally risky circumstances, regulations already provide for the child to end participation at any point in the procedure. While there is no absolute guarantee that all researchers will be exquisitely sensitive to a child's body language or other nonverbal signs of distress, researchers are required to honor a child's refusal or reluctance to continue an activity or interview. Thus, the argument that only by age 14 are children capable of protecting themselves from risky or distressing research loses its force.

The second reason for advocating a lower age for the assent requirement is that in the current atmosphere of child-rearing advice, where reasoning with even young children and encouraging independence and decision making is recommended, children are more practiced at these skills than, say, a decade ago. ¹ Thus, we should perhaps be skeptical of competency-of-children arguments based on empirical research from ten years ago or longer.

The third reason for objecting to abandoning the assent requirement for children younger than 14 addresses the argument that some children might be particularly immature and thus unable to give authentic assent because of cognitive deficits, susceptibility to outside influences, or lack of development of genuine altruistic or other sustained value beliefs.², ³

Wendler and Shah dismiss the idea of individualizing assessment of assent and thus justify the older chronological criterion. It is an interesting challenge to devise reasonable and practical ways to assess the authenticity of a child's assent, but I propose that it is not as difficult as it initially appears and should be done as a way of showing respect for the child.

The real difference between authentic and inauthentic assent lies not in the alternative chosen, but in the reasons that support it. In the much-quoted Weithorn-Campbell study (1982) of treatment decisions made by children, adolescents, and adults (which Wendler and Shah also cite), most subjects chose the treatment that physicians had judged the best; however, the older subjects were able to articulate good reasons for the choice, whereas young children were not. Thus, if child subjects are asked to assent or refuse participation in research, part of the informing process should be to ask their reasons. If a child answers, "I want to do it because my brother did it," one should be cautious about accepting that as genuine assent. But if the child says, "Because it might help my brother who has x disease" or "Because it might help other children some day, and I like to help people," those seem like thoroughly acceptable answers indicating authentic assent, all other things being equal.

If researchers protest...