The Presidential Commission for the Study of Bioethical Issues is continuing its public meeting in Chicago today. The Commission will resume its review of the ethics of pediatric medical countermeasures, a project that it has undertaken at the request of Health and Human Services Secretary Kathleen Sebelius.
To respond to Secretary Sebelius’ charge, the Commission is working to develop an ethical framework to assess pre-event pediatric medical countermeasure research.
That framework will be used to assess research that presents some of the toughest ethical challenges-pediatric research that poses more than minimal risk to healthy participants with no prospect of direct benefit to the participants.
This type of research is governed by 45 CFR 46.407, or “407 review process,” and 21 CFR 50.54. Most pre-event pediatric medical countermeasure studies would fall into this category.
In Administrative session yesterday, Members noted that the Commission is dealing with incredibly complex and difficult issues and that it is covering new ground in pediatric research ethics. Members agreed that the Commission must take the time it needs to address this topic carefully, thoroughly and transparently.
Yesterday, during public session, Commission Vice Chair James Wagner noted that the Commission would not reach conclusions at this meeting, but that it would begin the iterative process of refining the ethical framework.
The Commission is expected to finalize conclusions and recommendations at its next meeting in January. It will likely submit a formal report summarizing those conclusions and recommendations to Secretary Sebelius and the Administration in early 2013.