001 - Front Matter Executive Summary

Safeguarding Children Pediatric Medical Countermeasure Research responds to Health and Human Services Secretary Kathleen Sebeliuss call for an ethical examination of anthrax vaccine trials involving children. In January 2012, after a federal committee recommended initiating such research, the Bioethics Commission was tasked with investigating the ethical implications. Their findings emphasized that extensive adult testing is essential before any pediatric trials can ethically proceed. The Commission outlined rigorous conditions that must be satisfied before considering research on pediatric medical countermeasures (MCM), which encompass federally-regulated drugs and products used in response to chemical, biological, radiological, and nuclear threats. This report not only addresses the specific case of anthrax but also delves into broader ethical concerns surrounding pediatric research in the realm of medical countermeasures.