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

de-escalationwould help to ensure that data from an older age group inform the research design and risk level for the next younger age group. For example, an intervention shown to be minimal risk in the youngest adults adults 18 years of age may make it possible to infer that a study with the oldest children of 16 and 17 years of age would present only minimal risk.

When it is impossible to design a pre-event pediatric MCM trial that poses no more than minimal risk, the proposed study must first pass muster under a "national-level review." The Commission recommends a carefully specified set of strict preconditions before a national-level review of pre-event pediatric medical countermeasure research can proceed:

  • Researchers must demonstrate and reviewers must concur that it is impossible to design a minimal risk study; and
  • The proposed study still must pose no more than a minor increase over minimal risk to research participants, a level that still presents no substantial threat to a child's health or well-being.

If a proposed research trial reaches this point, the Bioethics Commission recommends that reviewers be required to employ the rigorous ethical framework that is developed in its report, and cautions that it should be applied only in the rare circumstances where research risks present a minor increase over minimal.

"Current regulations are ambiguously worded and review panels that would be examining proposed pediatric MCM research would have difficulty applying them consistently. Whether the criteria outlined in the Commission's ethical framework lead to approval or disapproval of proposed MCM research, they clarify what is at stake," Yolanda Ali, M.B.A., Bioethics Commission Member said.

If there is an attack, post-event MCM research might offer the prospect of direct benefit to participants, or of gaining generalizable knowledge about the participants' condition because the participants w
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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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