The Limits of Altruism and Arbitrary Age Limits

David Wendler and Seema Shah (2003) argue that the scope of children's decision making should be based on the principles of respect for autonomy and nonmaleficence. They suggest that these principles imply that assent should be required for minors over 14 years of age.

According to Wendler and Shah, "the autonomy rationale implies that the threshold for assent should be fixed at the age (most) children become capable of making their own research decisions." Moving specifically to the issue of children's participation in nonbeneficial research, they further argue that "the autonomy rationale suggests the assent threshold should be fixed at the age when (most) children develop the concept of altruism." Empirical data are then provided to support the claim that altruism develops "somewhere in the range of 10 to 14 years of age." Next, relying on the principle of nonmaleficence, Wendler and Shah advocate choosing "the highest age in the range"—that is, 14—as the threshold for assent to participate in nonbeneficial research.

In our view, several of the assumptions underlying the conclusion that the threshold for assent should be fixed at age 14 are problematic. First is the assumption that the capacity for assent to research participation should correlate with children's capacity for "making their own research decisions." This strikes us as a fundamental error. Once "children become capable of making their own research decisions," their "consent," not "assent," is required. A second problematic assumption is that altruism is central to the ascription of capacity to assent. In our view, the capacity for altruism and the capacity for assent are independent constructs. Third is the assumption that practical motives are sufficient to justify the choice of an arbitrary age-based demarcation line for assent. We perceive this as unwarranted discrimination.

The Difference between Consent and Assent

It is widely acknowledged that research involving human beings should not proceed without appropriate authorization. As we have argued elsewhere:

For persons with decision-making capacity, this authorization is their informed consent to research participation. For persons without decisional capacity (and this typically includes most children), this authorization is the permission to proceed granted by a legally recognized surrogate decisionmaker. For children, the legal surrogate decisionmaker is most often the parents. (Baylis, Downie, and Kenny 1999)

In addition, in North America it is also widely recognized that there are circumstances (e.g., when a child's capacity for judgment and self-direction is maturing) when the authorization of surrogate decision makers (e.g., parents deciding for their children) is insufficient. In these instances the research participants' assent to research participation is also required. The term assent rather than consent is used to distinguish between "agreement with" and a "decision to." On this view, respect for autonomy requires that children capable of decision making be allowed to consent to or refuse research participation, whereas children who are incapable of providing a legally and ethically valid consent are to be provided with an opportunity to "assent" (or not) to research participation as a measure of respect for their developing autonomy.

Against this common understanding of the meaning and moral relevance of consent and assent, we fail to understand Wendler and Shah's assertion that "the threshold for assent should be fixed at the age (most) children become capable of making their own research decisions." Leaving aside any claims about age, if children are capable of making their own decisions, they are capable of offering their own morally valid consent or refusal.

The Limits of Altruism

Wendler and Shah maintain that the purpose of nonbeneficial research is "to develop generalizable knowledge that might help future patients." They further argue that children need to understand this purpose to make a decision regarding participation in such research. On this basis Wendler and Shah confidently assert that "the capacity to decide whether to enroll in nonbeneficial research requires children to...