The Presidential Commission for the Study of Bioethical Issues is meeting today and tomorrow in Miami, Florida (January 14-15, 2013).

At this meeting the Commission is expected to wrap up its exploration of the issues surrounding the ethical issues associated with research that could carry some risk in order to protect children from high consequence events that have an unknown or unknowable likelihood of occurring.

At the request of Health and Human Services Secretary Kathleen Sebelius, the Commission is carefully reviewing the ethical considerations of conducting clinical trials of medical countermeasures for children.

As she opened the first session Commission Chair Amy Gutmann, Ph.D., said, “We must keep in mind that we do not have a research protocol before us.  We are not equipped to sit as an IRB or a national review panel under Section 407 and it is outside the purview of our Charter to do so. The question we must address is whether the U.S. Government could ethically support a pediatric AVA study under any circumstance.  We will not render a final decision as to whether a particular study should move forward.  Nor are we working to justify any particular protocol or outcome.”

The meeting will be mostly devoted to Commission member discussion of this ethically complex issue. Guest speakers Dennis F. Thompson, Ph.D. of the Kennedy School of Government at Harvard University and Tom L. Beauchamp, Ph.D. of the Kennedy Institute of Ethics at Georgetown University will discuss the philosophical grounding the Commission may consider to its ethical approach to this issue.