Presidential commission comments after meeting on MCM trials with children

Members of the Presidential Commission for the Study of Bioethical Issues met on Monday and Tuesday to discuss the ethical considerations of conducting clinical medical countermeasure trials with children.

The Miami meeting took place after a careful and transparent review of the many challenging and complex issues related to the research. The research into countermeasures for anthrax and other biological agents could carry some risk to protect children from events that have an unknowable likelihood of happening.

"We are more resistant in this case to research than we were in the genome project," Christine Grady, an R.N. and a member of the commission, said. "I think that the reason we are is because it's MCM research. I don't think anybody around this table is saying that research with children in general is not a good thing if it finds ways to treat children who are ill, or prevents illness in children. The issue here of course ... is that these are conditions that may never happen, that we hope never will happen, and so we're sort of balancing a different kind of need than we would be if it was studying a treatment for a disease that kids have."

Last week, the Alliance for Human Research Protection accused the Obama administration of using the public meeting of the commission to plan to test MCMs on unprotected children who are legally incapable of giving informed consent.

"(In post-event research) there are still ethical guidelines, but they have a different implication when children stand to directly benefit from research," Amy Gutmann, the commission chair, said. "And then you impose no more than necessary risk. Risk has to be proportionate to the benefit and you still want the informed consent of parents and if possible of children, but there is a direct benefit to the child and that makes all the difference and we absolutely will make sure we articulate that in the report."

Col. Nelson Michael, another member of the commission, said that if studies took place at all, they would be conducted with the least risk possible for children.

"At previous meetings, we heard from experts that, as a result of routine distribution to members of the military, (anthrax vaccine adsorbed) has been studied with young adult populations; and, observational studies with young adults have contributed to our knowledge about the safety and immunogenicity of AVA," Michael said. "Yet, some experts have also told us that additional data from adult populations-information, for example, from dose sparing studies-is needed before pediatric testing can begin. In the future, with existing information and additional data from young adults, it may be possible to design AVA research with 16 and 17 year-olds that involves only minimal risk."

The meeting was the commission's fourth on the topic. The commission advises the president on bioethical issues related to advances in biomedicine, technology and science and identifies and promotes practices that ensure ethical and social responsibility of scientific research, healthcare delivery and technological innovation.