Bioethics Blogs

Safeguarding Children in Emergencies through Ethical Pediatric Research

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.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.