"No more than minimal risk" for vaccine trial
The federal government would have to take multiple steps before anthrax vaccine trials with children could be ethically considered, according to a March 2013 report from the Presidential Commission for the Study of Bioethical Issues.
"Research with children is ethically distinct from other research, especially when the research in question promises no prospect of direct benefit for the participants," explains Lisa M. Lee, PhD, MS, the Commission's executive director.
While competent adults can consent to accept risks for the benefit of others during research, children are legally prohibited and ethically unable to consent to accept this burden.
"Pre-event pediatric research involving medical countermeasures, like Anthrax Vaccine Adsorbed, involves testing children for a hypothetical condition with an undefined — and perhaps unknowable — likelihood of occurring," says Lee. No child today, for example, is suffering from an inhalational weaponized form of anthrax; therefore, there is no prospect of direct benefit. "While the knowledge gained could be profoundly useful in the event of an attack, we may never have — and hope never to have — occasion to use it," says Lee.
Because individual children who would be enrolled in pre-event medical countermeasures research do not stand to directly benefit from the research, or have no condition about which generalizable knowledge is likely to be gained, the Bioethics Commission concludes that, absent extraordinary circumstances, pre-event medical countermeasures research with children is ethical only if it presents "no more than minimal risk" to study participants.
"Minimal" risk means no greater risk than that routinely faced by a healthy child in daily life or during a medical check-up, explains Lee. If minimal risk research is not possible, national level review is necessary.
In keeping with its recommendation of a strict risk limit in pre-event pediatric medical countermeasures research, the Bioethics Commission calls for completing all prior ethically sound testing — for example, modeling, testing in animals, and testing in the youngest adults — to assess the level of risk likely posed by pre-event pediatric medical countermeasures research.
If the risk level for the oldest group of children is determined to be minimal and it can be scientifically inferred that the risk would be similar in the next youngest group, the Bioethics Commission recommends that progressive testing with younger and younger children could be employed, beginning with the oldest children in order to provide additional protection to younger children.
"This approach — called age de-escalation — would help to ensure that data from an older age group inform the research design and risk level for the next younger age group," says Lee. "The research could only continue to the next level if the risk is determined to be minimal."