Effective medical countermeasures, in which federally-regulated drugs and products are used in response to chemical, biological, radiological, and nuclear attacks, are established based on research trials similar to drug development clinical trials. But there is concern among officials about how to protect minors and pediatric patients during this type of research, and whether or not the research should be performed on children at all.

The Presidential Commission for the Study of Bioethical Issues addressed these issues in response to a request last year from Health and Human Services Secretary Kathleen Sebelius regarding proposed anthrax vaccine trials.

“The Bioethics Commission recognizes both the federal government’s fundamental duty to protect individual children from undue risk during research and its obligation to protect all children—as far as ethically and practically possible—during an emergency by being prepared,” says Daniel Sulmasy, member of the Bioethics Commission.

Following a 2011 bioterrorism preparedness exercise estimating almost 8 million casualties, including nearly 2 million children, from release of weaponized anthrax spores in a large city, the National Biodefense Science Board recommended the U.S. government conduct a trial to test the safety and effectiveness of the anthrax vaccine in children, contingent upon review of the ethical issues, a review which Sebelius then requested.

The report, Safeguarding Children: Pediatric Medical Countermeasure Research, concludes that pre-event trials, in which testing occurs before an actual or imminent attack, not go forward with children in the absence of complete testing on adults.

It also recommends that all prior ethically sound testing, including modeling, testing in animals, and testing in the youngest adults be complete; that age de-escalation studies be performed in which the safety information from the older group informs the trial in the next younger group; and that medical countermeasure research in children is ethical only if it presents the same risk as routinely faced by a healthy child in daily life or at a medical check-up.

“The safety of our children is paramount and we have to get this precisely right,” said Commission Chair Amy Gutmann. “The Bioethics Commission concludes that many significant steps would have to be taken, including additional minimal-risk research with adult volunteers, before pediatric anthrax vaccine trials prior to an attack should be considered.”

Children are a unique population, the government acknowledges, since they do not stand to benefit directly from participating in a study, nor are they legally and ethically able to consent to accept the burden of risk for the benefit of others as required in a research trial. “The rules that protect children are even more stringent, as they should be,” says Gutmann. “Out of respect for every individual, our nation must protect children enrolled in research studies while also doing its best to develop the knowledge needed to save children’s lives during a possible emergency.”

In December 2011, the commission published a report recommending 14 changes to existing practices in order to better protect research subjects; this new report builds on that foundation.