Context in Shaping the Ability of a Child to Assent to Research

David Wendler and Seema Shah (2003) argue that the threshold for assent to participation in nonbeneficial research should be fixed at 14 years of age. Their argument is based on claims about childhood development of a concept of altruism and a requirement to promote nonmaleficence. In my view the proposed age limit is too restrictive; it does not take into account the potential influence of relevant contextual factors of the child, including personal experience of chronic illness and the social, familial, and cultural contexts that can be powerful determinants of a child's ability to assent to nonbeneficial research (Baylis, Downie, and Kenny 1999).

Chronic illness by its nature is integrated into a sense of one's being (Jennings, Callahan, and Caplan 1988). A substantial proportion of all children (approximately 10%) suffer from chronic illness of some degree and duration (Stein et al. 1993), ranging from mild disease that has minimal impact upon function or quality of life to those illnesses, such as cancer, that are life threatening and have profound and long-lasting effects. Even if a chronic illness is cured, the experience of coping with the illness invariably shapes children's development and their concepts of themselves and others and impacts upon parental and familial functioning. Chronic illness is frequently the subject of beneficial research and thus children with chronic conditions may bring this experience to the prospect of nonbeneficial research in which they are asked to participate.

Chronic illness may influence children's ability to assent to research participation in complex ways (Fernandez 2002). Children with chronic illness may have an improved ability to provide a morally-valid assent, or they may be less able to do so. This ability will fluctuate with time, ongoing cognitive development, and the severity of the underlying illness. On the one hand, children with chronic illness may bring a more mature decision-making capability to the question of participation in nonbeneficial research by virtue of previous experience with researchers and possible participation in beneficial research. For example, exposure to the concept of research occurs frequently in pediatric oncology, where more than half of North- American children with cancer and their families are offered clinical research participation through the Children's Oncology Group (Bleyer 1997). Similarly, the life-experience of chronically-ill children—contact with medical, nursing, allied health, and technicians—may help children bring a fuller understanding to the question of research participation (Brewster 1982).

Children with chronic illness also have the opportunity to interact with their peers with similar illnesses and thus to be concretely exposed to the reality that people like themselves can benefit from their own altruistic participation in research. They tend to have an accelerated understanding of the concept of illness that no doubt contributes to their understanding of the rationale for, and potential impact of, research (Leikin 1993). While potential benefit to others is probably most tangible with beneficial research, a positive view of the role of research in enhancing the well-being of others cannot help but spill over into nonbeneficial research.

On the other hand, children with chronic illness may be more vulnerable to inadequate assent. A good example of this is in the realm of Phase I trials (dose-finding and toxicity studies), where no therapeutic benefit should be expected for participants (response rates are generally documented to be less than 3%; Horng et al. 2002). Children participating in Phase I studies are usually dying and are thus vulnerable to many issues that may detract from their ability to adequately express assent or dissent to research participation. Researchers may inadvertently exploit a sense of desperation for "any hope of cure," there may be inadequate ability to concentrate on complex issues by virtue of the effects of serious illness, and there may be significant pressure from friends or family to participate in research in the hope of a cure, however small...