Altruism, Children, and Nonbeneficial Research

David Wendler and Seema Shah (2003) consider the question of when to require assent from children for nonbeneficial research and suggest fixing that age at 14 years. Doing so would have the paradoxical effect of negating the expanding respect, evident in [on-line perusal] institutional review board (IRB) policies, for the interests, needs, and rights of minors. Wendler and Shah's conclusion is based on a limited appreciation of the experimental studies of altruism and would expose children to exploitation by requiring advanced levels of moral universalism from minors without similar concern for the motivations of parents and researchers.

In discussing assent, Wendler and Shah appear to conflate informed consent and assent. In stating that they are seeking a specific age requirement for assent by identifying "the age at which children come to understand and appreciate the purpose of research—that is to say, the final or last-to-develop element of informed consent," they reveal this confounding of assent and consent.

"Assent is defined as a child's affirmative agreement to participate in research" (Protections for Children in Research 2001). By its nature assent differs from informed consent; it is usually meant to describe those situations in which minors, or other not fully decisionally-capacitated individuals, indicate willingness to participate in research without necessarily fully understanding the complete significance of the research. The requirement for assent safeguards the developing personhood of the child and ensures that researchers treat the child with respect and consideration. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) wrote "children who are seven years of age or older are generally capable of understanding the procedures and general purpose of research and of indicating their wishes regarding participation." The process of eliciting the assent of children ensures that children will not be dehumanized. Researchers seek the assent of children involved in experimental studies because they do not want to be the kinds of people who would use children as objects. Researchers' moral sense of the appropriateness of their actions is enhanced when they communicate face-to-face with children while explaining the research, its significance, and what will be required of the child participants. Eliminating the requirement for assent would place researchers, parents, and society at risk of misusing the vulnerabilities of children and failing to recognize the uniqueness of the individual. Using moral imagination to visualize the practical situation of a researcher and the child/subject exposes the inappropriateness and inhumanity of doing research on uninformed, unaware, unassenting children. The scenario would be appalling. It is simply offensive to suggest enrolling children above the age of seven in research, unless their capabilities are severely limited, without enlisting their cooperation when the research offers them no prospect of benefit. Researchers must care enough to engage youngsters in conversation; to tell them about the research project; to ask them if they would agree to help; and, if they say "yes," to ask them why. To suggest, as Wendler and Shah rightly do, that children before the age of 14 should have a right of dissent implicates the correlative requirement for the right of assent. The principle of nonmaleficence will be violated if children are forced to participate in research when they have not assented to do so, because such actions will surely cause more than minimal distress. Suggesting "practical diffi- culties in assessing understanding and appreciation" as a reason to support a general age threshold substitutes legalistic standards for the process that researchers are expected to engage in with subjects.

In making their case for fixing the age for assent at age 14, Wendler and Shah actually seem to be suggesting that the minor of age 14 or older is able to give informed consent. If this is their point, then their argument should be about eliminating the need for parental consent to enroll in research. Suggesting that a necessary condition for enrollment in nonbeneficial research is...