NIH’s New Definition of “Children” Finally Gets it Right: A Welcome Change for Children’s Health Equity

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By Celia B. Fisher, Ph.D.

Under current federal research regulations, a “child” is defined as an individual younger than 21 years of age – a policy that has produced inequities in health research for youth younger than 18 years of age.

Beginning January 25th, 2016, that will change: the age of a child will be defined as an individual less than 18 years old. This is a welcome change that can begin to address the urgent need for age- and population-targeted research to avoid the use of treatments tested in young adult populations that may be unsuited for adolescents and children.

In 1998 the National Institutes of Health and the Food and Drug Administration set forth a policy requiring applications for federal biomedical research funding to justify why children were not included in the study design. Prompted by Congress, this dramatic change in policy arose in response to growing evidence that over-protective interpretation of regulations excluding children from clinical trial research had created a population of “research orphans” whose only treatment options were those tested on adults.

Unfortunately, the policy defined children as “under the age of 21” resulting in de facto permission for investigators to claim that clinical trials involving young adults ages 18 – 21 years met the new regulatory requirement, thus sustaining rather than ameliorating the dearth of evidence-based interventions essential to children’s health and wellbeing.

This de facto research agenda has been particularly disastrous for much-needed empirical work on effective prevention strategies for health compromising behaviors, such as substance abuse and HIV risk in early and mid adolescence. A perusal of the research literature indicates that many published studies claiming to represent “adolescent” populations are in fact limited to youth older than 18 years, resulting in a lack of age-appropriate interventions.

However, even with the new NIH definition of “children,” adolescent research inequities will continue until state legislatures and federal regulators address the major factor contributing to the paucity of research essential to adolescent health—laws prohibiting youth under 18 years of age from accessing sexual health and other forms of essential health care need without parental permission, and the reluctance of many institutional review boards (IRBs) to approve adolescent research, even when state laws permit youth self consent.

Hopefully this change in regulations is just a first step in recognizing the autonomous rights of youth to equitable access to health care and to participate in research that will protect them from receiving developmentally untested, inappropriate, and unsafe treatments.

Dr. Celia B. Fisher is the Marie Ward Doty University Chair, Professor of Psychology, and Director of Fordham University’s Center for Ethics Education and the HIV and Drug Abuse Prevention Research Ethics Training Institute. She chaired the 2002 revision of the American Psychological Association’s Ethics Code and is author of Decoding the Ethics Code: A Practical Guide for Psychologists, 3rd edition, Sage Publications.


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