The American Journal of Bioethics

David Wendler and Seema Shah (2003) propose that "the threshold for assent should be fixed at 14 years of age, and a dissent requirement should be adopted for all children in the context of nonbeneficial research." Their argument is as follows:

1. the analysis of assent should begin with the principle of respect for subject autonomy;
2. the age of assent should thus reflect the capacity to make autonomous decisions, understood as the understanding and appreciation necessary for voluntary and informed consent;
3. the concept of altruism is essential for appreciating the moral reasons for participation in nonbeneficial research; [End Page 11]
4. the capacity for understanding altruism as a "moral motivation" for research participation develops between the ages of 10 and 14 years;
5. the lack of this developmental capacity prior to the age of ten renders the pedagogical role of assent futile and potentially distressing to the younger child;
6. 14 years should be chosen as the age at which assent should be required, as adequate research enrollment is more important than failing to seek the assent of a younger child who might be capable of assent; and
7. the principle of nonmaleficence requires that a child's dissent to participation in nontherapeutic research be honored.

We will argue in this commentary that

1. the analysis of assent should begin with the principle of respect for children (i.e., persons) and not respect for subject autonomy;
2. as a result, assent should be understood as "the opportunity to choose to the extent they are able" (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979) rather than making an autonomous decision;
3. the capacity for altruism might occur at a younger age than proposed by Wendler and Shah; and
4. the failure to require assent at a younger age risks harm to children who might be unduly influenced by their knowledge of parental (and perhaps other adult) wishes.

Autonomy or self-determination is not an appropriate model for understanding either parental permission or child assent. When applied to children, the principle of respect for persons found in The Belmont Report (National Commission 1979) incorporates both parental permission and child assent. Parental permission serves to protect the child while the child's capacity for self-determination matures. Thus, child assent cannot be understood properly outside of the context of parental permission that bears (at a minimum) the burden of determining an appropriate risk exposure for the child. Relieved of meeting the standard for autonomous choice, the child's assent can be limited to a simple preference for (or dissent from) research participation (Denham and Nelson 2002). Rather than judging children against a standard set of elements of informed consent, as Wendler and Shah do, assent (and thus the capacity for assent) should be understood differently at different developmental levels (Nelson and Reynolds 2003). Wendler and Shah reduce child assent to the two extremes of adolescent consent and child dissent and fail to appreciate the complex and diverse viewpoints of preadolescent children about nontherapeutic research par-ticipation. We agree that Wendler and Shah neglect "the interconnected nature" of parental permission and child assent (Joffe 2003), and that "goodness-of-fit" between a child's maturing capacity and the elements of assent is a more appropriate model for decision making (Fisher 2003).

Are children younger than ten years of age capable of altruistic motivation for nonbeneficial research participation? Although Wendler and Shah acknowledge that young children might want to help other people, they believe that those "younger than 10-12 years old behave altruistically for nonaltruistic reasons." In other words, they believe that helping is an instrumental means to reach the ultimate goal of benefiting oneself...