Safeguarding Children: Pediatric Medical Countermeasure Research is the response from the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) to a request from Health and Human Services Secretary Kathleen Sebelius. In January 2012 Secretary Sebelius asked the Bioethics Commission to study the question of anthrax vaccine trials with children after receiving a recommendation from another federal committee that such research be initiated, pending ethical review. In this report the Bioethics Commission concluded that the federal government would have to take multiple steps before anthrax vaccine trials with children could be ethically considered. In addition to recommending that pre-event trials with children not go forward in the absence of further testing on adults, the Bioethics Commission clarifies other rigorous conditions that must be met before such pediatric research is ethically considered.
In this report the Bioethics Commission also more generally considered the ethics of research on pediatric medical countermeasures (MCM), the catchall term for the use of federally-regulated drugs and products in response to chemical, biological, radiological, and nuclear attacks.