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President's Bioethics Commission releases report on pediatric medical countermeasure research
Date:3/18/2013

no prospect of direct benefit for the participants. 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.

Pediatric MCM research that would take place before a bioterrorism attack occurs is also ethically distinct from pediatric MCM research that would take place after an attack. Pre-event pediatric research involving MCMs involves research on a hypothetical condition with an undefined (and perhaps unknowable) likelihood of occurring.

"While the knowledge gained could be very useful in the event of an attack, we may never have and hope never to have occasion to use it," Gutmann said.

By contrast, post-event testing offers a chance of directly benefiting participants and the opportunity to learn about their condition, which resulted from the attack.

Because the individual children who would be enrolled in pre-event MCM research do not stand to directly benefit from the research, the Bioethics Commission concludes that, absent extraordinary circumstances, pre-event MCM research with children is ethical only if it presents "no more than minimal risk" to study participants, where "minimal" means no greater risk than that routinely faced by a healthy child in daily life or at a medical check-up.

In keeping with its recommendation of a strict risk limit in pre-event pediatric MCM research, the Bioethics Commission called 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 MCM research. If the risk level for the oldest group of children is determined to be minimal, then progressive testing with younger and younger children should be employed, beginning with the oldest children in order to provide additional protection to younger children. This approachcalled age
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Contact: Hillary Wicai Viers
hillary.viers@bioethics.gov
202-233-3960
Presidential Commission for the Study of Bioethical Issues
Source:Eurekalert

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