Knowing Who You Want to Be When You Grow Up: Implications for Pediatric Assent

David Wendler and Seema Shah (2003) suggest two prerequisites for autonomous decision making by children approached to participate in pediatric research. First is the capacity of children to understand the proposed study, its purpose, the procedures involved, the potential risks and benefits of research participation, and any available alternatives. If a child lacks the capacity to understand this basic, decisionally-relevant information about the study, then that child's expression of assent cannot be said to be fully autonomous. Second, Wendler and Shah suggest that children must be able to assess how their participation in a research study might "further their conception of a flourishing life." If a child comprehends the various procedural aspects of a study but lacks the ability to assess the relevance of this information to the pursuit of his or her personal goals then, like the child who lacks understanding, the child's decision making cannot be said to be fully autonomous. If children are to be autonomous decision makers in the morally robust sense envisioned by Wendler and Shah, they must both understand the study and appreciate how their involvement might (or might not) help them to achieve their individual goals.

Like other commentators (Baylis and Downie 2003; Botkin 2003; McGee 2003; Nelson and Reynolds 2003), we believe the analysis offered by Wendler and Shah conflates the normative commitments of pediatric assent with those associated with the solicitation of informed consent from adult volunteers (see Faden, King, and Beauchamp 1990; Beauchamp and Childress 2001). In addition, pediatric practice tends to support the involvement of children in many clinical decisions, commensurate with the child's developmental capacity, with the recognition that in many cases treatment must be pursued even when meaningful assent cannot be obtained (American Academy of Pediatrics Committee on Bioethics 1995). These are not the points we wish to discuss, however. Suppose one agrees with Wendler and Shah that pediatric assent, like informed consent, requires the "child volunteer" to deliberate whether, on balance, participation in research is more or less likely to help in the attainment of his or her personal goals, whatever those might be. Even if one adopts this perspective, we believe Wendler and Shah's analysis of pediatric assent is problematic and fails to recognize a third essential component of autonomous decision making in research; namely, a mature and enduring notion of what human flourishing entails.

A clear concept of human flourishing, developed from personal experiences with the negotiation of morally- challenging situations, provides a landmark by which adult decision makers navigate uncharted moral waters and situate important decisions about such things as participation in research. Unlike most adults, many young children and adolescents have not yet struggled to find balance between competing moral obligations to family and self, personal health and devotion to others, pursuit of material interests and service to community, and so forth. Lacking these experiences of moral reflection, children might both understand and appreciate the study's potential implications but still be incapable of the robust autonomous decision making envisioned by Wendler and Shah.

If young children and adolescents have not yet defined for themselves which things matter most in their lives, then their conception of human flourishing might be too fleeting and poorly defined to anchor research decision making. This implies a need to evaluate children for a mature and enduring notion of what human flourishing entails when assessing whether a given pediatric research candidate is capable of autonomous decision making and assent to research participation.

In addition, these considerations suggest an interesting empirical question, namely, at what stage in their moral development do children acquire a clear and stable sense of what human flourishing entails? Studies in developmental psychology have not been framed in a manner that would allow us to answer this...