Conducting ethical post-event medical countermeasure trials with children

The Presidential Commission for the Study of Bioethical Issues enumerated the ethical considerations of conducting pediatric clinical trials of medical countermeasures (MCM), which are interventions to protect children in case of a terror attack. Conducting MCM research after the occurrence of an attack poses considerations that are ethically distinct from research before an event. The justification no longer relies on speculation of benefit, but, rather, on tangible benefits that might accrue to children exposed to an agent. Because children in general, or an identifiable class of exposed children, could benefit from knowledge resulting from such research, the ethical analysis is altered. The potential for benefit makes post-event research ethically imperative both as a matter of beneficence in meeting ethical obligations to benefit children, and justice in meeting ethical obligations to secure the well-being of the most vulnerable. While they differ from pre-event research in character and type, ethical and logistical challenges still exist in post-event pediatric research. These include ensuring access to the best available care, navigating implementation of research protocols under stressful circumstances, confounding of treatment and research effects, and using unapproved or untested medications in children. Two regulatory mechanisms—the Emergency Use Authorization and Investigational New Drug application—help public health authorities mobilize both treatment and research resources in case of an emergency while maintaining the safest and most ethical research framework.