Online Program

Conducting ethical post-event medical countermeasure trials with children

Monday, November 4, 2013 : 5:10 p.m. - 5:30 p.m.

Christine Grady, MSN, Ph.D., Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, MD
Nelson Michael, M.D., Ph.D., U.S. Military HIV Research Program (MHRP), Walter Reed Army Institute of Research, Bethesda, MD
Lisa M. Lee, PhD, MS, Presidential Commission for the Study of Bioethical Issues, Washington, DC
The Presidential Commission for the Study of Bioethical Issues enumerated the ethical considerations of conducting pediatric clinical trials of medical countermeasures (MCM), which are interventions to protect children in case of a terror attack. Conducting MCM research after the occurrence of an attack poses considerations that are ethically distinct from research before an event. The justification no longer relies on speculation of benefit, but, rather, on tangible benefits that might accrue to children exposed to an agent. Because children in general, or an identifiable class of exposed children, could benefit from knowledge resulting from such research, the ethical analysis is altered. The potential for benefit makes post-event research ethically imperative both as a matter of beneficence in meeting ethical obligations to benefit children, and justice in meeting ethical obligations to secure the well-being of the most vulnerable. While they differ from pre-event research in character and type, ethical and logistical challenges still exist in post-event pediatric research. These include ensuring access to the best available care, navigating implementation of research protocols under stressful circumstances, confounding of treatment and research effects, and using unapproved or untested medications in children. Two regulatory mechanisms—the Emergency Use Authorization and Investigational New Drug application—help public health authorities mobilize both treatment and research resources in case of an emergency while maintaining the safest and most ethical research framework.

Learning Areas:

Ethics, professional and legal requirements
Public health or related public policy
Public health or related research

Learning Objectives:
Compare the ethically distinct considerations of pediatric medical countermeasure (MCM) resarch after the occurrence of a terror attack with pre-event considerations. Identify the ethical and logistical challenges that exist in post-event pediatric MCM research.

Keyword(s): Pediatrics, Research

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I serve as a member of the Presidential Commission for the Study of Bioethical Issues, the body that developed the work presented in this abstract. I am a nurse and philosopher with decades of research and ethics experience, appointed by the President to his Bioethics Commission.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.