Panel urges caution in testing kids' anthrax vaccines

A presidential advisory panel released ethical standards Tuesday to govern controversial medical tests on children, a move that will allow some research to move forward.

The Presidential Commission for the Study of Bioethical Issues was asked to report on how researchers could ethically test a pediatric anthrax vaccine on kids who, not being sick from anthrax, would not stand to benefit from the studies.

The panel responded with a set of guidelines to help scientists navigate the risks involved involved in pediatric medical research, particularly studies that test countermeasures designed for epidemics or bioterrorist attacks. 

"All research must be designed to pose only minimal risk to child participants," the panel said, using a phrase repeated often throughout Tuesday's report.

"Minimal risk" is defined as what a child might experience in everyday life or during a check-up.

In this absence of this possibility, the commission added, studies should only allow a "minor increase over minimal risk," or the consequences of a slightly more complex medical procedure, such as a skin biopsy or chest X-ray.

The report outlined process known as "age deescalation" in which testing could also progress from older teenagers down to younger children.

Amy Guttman, the panel's leader, called this "the best scientific process" available.

"Out of respect for every individual, our nation must protection children enrolled in research studies while also doing its best to develop the knowledge to save children's lives during a possible emergency," she said in a statement.

The study was undertaken after a request from Health and Human Services Secretary Kathleen Sebelius. It comes two years after the National Biodefense Science Board recommended that the federal government sponsor research on pediatric countermeasures for anthrax.

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