Why a Teenager over Age 14 Should Be Able to Consent, Rather than Merely Assent, to Participation as a Human Subject of Research

U.S. federal regulations require the consent of both a parent (sometimes two parents) and the child who is contemplating participating as a human subject in research. The requirement that the child consent, which the regulations call "assent," gives to two different sources of authority—parents and child—the power to veto the child's participation in the research. This requirement might be based on the presumption that it is better to err on the side of not participating as a research subject, at least where the research is nontherapeutic, or it might be based on the presumption that without this requirement children would be insufficiently involved in the decision-making process leading to their participation in research. The first of these is fully discussed by David Wendler and Seema Shah (2003) and the thoughtful commentators who have responded to their article. The second presumption—that children should be more involved in the decision to become research subjects—is also well addressed with regard to children under age 14, where Wendler and Shah would replace the "assent" requirement with a "dissent" requirement.

While we are concerned with the bifurcated research consent/assent process for all children, our primary concern is with the formal legal consent requirement that allows parents to veto the decisions made by children over age 14 who decide to participate in research as human subjects. In fact, at age 14 children generally ought to be recognized as independent agents who are capable of making all of their healthcare decisions, including the decision to participate as a research subject, without the threat of any parental veto. The real reason for the regulatory "assent" requirement for these children is that the legal rule in every state that gives the authority to consent to parents of teenagers under 18 does not reflect the real decision- making capabilities of those young adults. The proper way to address this issue is to recognize the legal authority of those over 14 to make all of their own healthcare decisions, including the decision to participate as a human subject in any kind of research.

As Wendler and Shah and their commentators point out, maturity and the ability to make sound decisions do not suddenly appear on a child's eighteenth birthday. Moral and emotional development are gradual processes. Studies have shown that most children are as mature and emotionally developed at age 14 as they are at age 18. In a 1982 study the decision making of different age groups—9-year-olds, 14-year-olds, and 21-year-olds—were tested with regard to a hypothetical illness and proposed medical treatment. The subjects' understanding of facts, treatment outcomes, choices to be made, and decision-making processes were studied. While the nine-year-olds were a bit more conservative and chose inpatient care more often, the 14-year-olds and the 21-year-olds generally made the same decisions (Schlam and Wood 2000). In another study, one in which children were asked to give health advice to their peers, 12-year-olds were found to be as competent as 19-year-olds (Cauffman and Steinberg 1995).

In order to be capable of giving informed consent to medical treatment, children (or adults, for that matter) must be able to understand the nature, extent, and probable outcome of treatment. They must be able to understand the information provided and rationally make and voluntarily reach a decision (Schlam and Wood 2000; Furrow 2000). The American Academy of Pediatrics (AAP Committee on Bioethics 1995) has not only supported the finding that children achieve decisional capacity much earlier than is recognized by state laws, but it recommends that adolescents should be...