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.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.