The Presidential Commission for the Study of Bioethical Issues has issued a report which concludes that “the federal government would have to take multiple steps before anthrax vaccine trials with children could be ethically considered.” Titled “Safeguarding Children: Pediatric Countermeasure Research,” the March 2013 report seeks to balance the demands of safeguarding children during emergency situations while recognizing “a fundamental duty to protect children from undue risk during research.” The Health and Human Services secretary asked the commission to advise the U.S. government “on ethical considerations in evaluating and conducting pediatric medical countermeasure (MCM) research.” Specifically, the commission was asked to consider the ethics of conducting interventions both before and after an attack, such as with the anthrax virus.

Because pediatric research with no prospect of direct benefit to participants and not likely to yield generalizable knowledge about the participants’ conditions “can only be conducted if it presents no more than minimal risk, except in extraordinary circumstances,” the commission overall judged that pre-event MCM research “generally cannot proceed unless it is minimal risk research.” The report’s six recommendations address how to design minimal risk research, including conducting research that (i) “exposes children to no more than a minor increase over minimal risk,” (ii) first involves testing on animals and the youngest adults, and (iii) “meets the requirements of the framework outlined in this report.”

The commission built its report on previous work addressing the issue of protecting human research participants. According to commission chair Amy Gutman, “The rules that protect children are even more stringent, as they should be. Medical countermeasure research warrants an ongoing national conversation to ensure an unwavering commitment by our society to safeguard all children from both unacceptable risks in research and through ethically sound research that promotes their health and well-being.” See Presidential Commission for the Study of Bioethical Issues Press Release, March 18, 2013.