Informed assent

The term informed assent describes the process whereby minors may agree to participate in clinical trials. It is similar to the process of informed consent in adults, however there remains some overlap between the terms.

In adult medical research, the term informed consent is used to describe a state whereby a competent individual, having been fully informed about the nature, benefits and risks of a clinical trial, agrees to their own participation. National authorities define certain populations as vulnerable and therefore unable to provide informed consent, such as those without the necessary cognitive, psychological, or social maturity to understand these benefits and risks. The oft-reported belief that minors (for the purposes of this discussion, read minors as persons under the age of 18 years) are considered a vulnerable population and therefore may not autonomously provide informed consent, is actually an oversimplification that does not always hold true. In fact, the requirements for children participating in clinical trials are somewhat indistinct, with freedom to vary both between countries and within countries. For this reason, two terms have sprung into existence: pediatric consent and pediatric assent.

William G. Bartholome, MD, drafted the first statement for pediatric participation presented to the original American Academy of Pediatrics (AAP) Committee on Bioethics in 1985. The U.S. Food and Drug Administration encourages clinical trials in children in order to ensure the development of safe and effective pediatric medicines. According to the relevant Code of Federal Regulations (45 CFR 46, Subpart d), investigators wishing to conduct clinical trials in children in the United States are required to seek the permission of both parents and patients. This regulation defines informed assent as "a child's affirmative agreement to participate in research" and stipulates that mere failure to object cannot, without affirmative agreement, be taken as assent.

However, 45 CFR 46 does not specify an exact age at which informed assent must be obtained. Instead, it places responsibility for this determination with hospitals’ own Institutional Review Boards (IRBs). Increasingly, many such IRBs are adopting the ‘Rule of Sevens,’ which has formed part of common law for centuries and divides a child’s life into three sections: birth to seven, seven to fourteen, and fourteen to twenty one years old. Before 7 years old children are said to lack the cognitive development necessary for autonomous decision-making. At age 7 years children are considered able to distinguish right from wrong. Adolescents 14 years old and above are legally and socially accountable for their actions. Although not law, meaning physician can choose to ignore it, the rule of sevens is recommended by organizations including the American Academy of Pediatrics and in some areas, such as the state of California, has been written into local law.

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