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Posted on July 18, 2014 at 11:00 AM

Tomorrow, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) will present its recommendations on pediatric medical countermeasure (MCM) research at the 10th Annual Pediatric Bioethics Conference in Seattle. The conference, hosted by the Treuman Katz Center for Pediatric Bioethics at the Seattle Children’s Hospital, takes place July 18 and 19, 2014; its theme: “New Opportunities, New Challenges: Exploring the Ethical Boundaries of Pediatric Research.”

The Bioethics Commission is well versed on the issue, having addressed research with children in its 2013 report Safeguarding Children: Pediatric Medical Countermeasure Research. MCM includes federally regulated drugs and products for use in response to chemical, biological, radiological, and nuclear attacks (i.e., “events”). The report, requested in 2012 by former Health and Human Services Secretary Kathleen Sebelius, addresses the ethical considerations of conducting MCM research with children, as well as, more specifically, pediatric anthrax vaccine adsorbed (AVA) research. Safeguarding Children contains a set of recommendations for conducting ethical pediatric MCM research, both before and after a bioterror event, including an ethical framework the Bioethics Commission developed that specifies criteria for national-level review of certain types of pre-event MCM research. Associate Director Michelle Groman, J.D. will present the Bioethics Commission’s analysis and recommendations and discuss how the ethical framework can be applied to pediatric research.

The Bioethics Commission developed its ethical framework to aid the reviewers of proposed pre-event pediatric MCM research that poses greater than minimal risk (but no more than a minor increase over minimal risk) and offers no prospect of direct benefit to participants. Pre-event MCM research involves testing children for a hypothetical condition with an undefined (and perhaps unknowable) likelihood of occurring. The Commission’s framework clarifies review criteria outlined in existing research regulations: (1) does the research present a reasonable opportunity to increase the understanding, prevention, or alleviation of a serious problem that could affect the health or welfare of children; (2) will the research be conducted in accordance with sound ethical principles; and (3) are adequate provisions made for soliciting the permission of parents or guardians and the meaningful assent of children? Before pre-event pediatric MCM research in which there is no prospect of direct benefit can proceed, all three conditions must be met.

The Bioethics Commission’s ethical framework also can inform the conduct of pediatric research beyond MCM research. Many of the framework’s tenets are relevant to national-level review of pediatric research in other contexts; these include criteria for scientific necessity, fair subject selection, and community engagement. Whether in MCM or other research studies, extra care always must be taken when children serve as research participants. The ethical framework outlined in Safeguarding Children is useful guidance that any pediatric researcher could draw upon to ensure that they have addressed key ethical dimensions.

The Seattle Children’s Pediatric Bioethics Conference will be webcast live at and PDFs of speaker presentations and biographies will be made available after the sessions. Tune in on July 19 at 10:30 a.m. for the Bioethics Commission presentation “Recommendations from the Presidential Commission for the Study of Bioethical Issues: Safeguarding Children in Emergencies through Ethical Pediatric Research.”

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