Although decisional capacity develops through childhood and even into adulthood, practical and policy considerations have led policymakers to require, in most cases, that individuals achieve a specified age (the “age of majority”) before they can enter into contracts, consent to medical care, and make other crucial decisions in their own right. State policies are important for clinical research because federal regulations on human research protections define children as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted” (45 CFR 46.402; 21 CFR 50.3(o)). As described below, minors (those who have not achieved the age of majority) can still be held competent to consent to medical treatments under certain circumstances.
Consistent with recommendations in the National Commission’s 1977 report, federal regulations generally require assent to research participation from children judged capable of providing it. They define assent as “a child’s affirmative agreement to participate in research” and also state that “[m]ere failure to object should not, absent affirmative agreement, be construed as assent” (45 CFR 46.402(b); 21 CFR 50.3(n)). Assent is not, however, required if an IRB concludes that the research has the prospect of directly benefiting the child and that potential benefit is available only in the research context (45 CFR 46.405; 21 CFR 50.52). Assent may also be waived under the same conditions in which adult’s informed consent may be waived.
The federal regulations do not specify an age at which IRBs should expect investigators to begin to seek assent from children. Rather, IRBs are to consider the ages, maturity, and psychological state of the prospective research participants. In the committee’s experience, most IRBs require investigators to seek assent from children over the age of 6 or 7 years. The judgment about assent may apply to all the children who are to participate in a study or to each child individually. As discussed later in this chapter, the assent process for older adolescents may differ little from the process for seeking informed consent if that consent process is suitably structured. Thus, investigators would provide the same kinds of information as is required for adults.
The regulations permit oral presentation of assent information and allow discretion on the part of the IRB about the way assent is documented (45 CFR 46.117 (c)(2) and 45 CFR 46.408 (e); 21 CFR 50.55(g)). FDA guidance on pediatric drug research (developed by the International Conference on Harmonisation [ICH]) provides that “[p]articipants of appropriate intellectual maturity should personally sign and date either a separately designed, written assent form or the written informed consent” (FDA, 2000b, p. 19781, emphasis added). Although the ICH guidance puts more