Online Program

Conducting ethical pre-event medical countermeasure trials with children

Monday, November 4, 2013 : 4:50 p.m. - 5:10 p.m.

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
Christine Grady, MSN, Ph.D., Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, MD
Michelle Groman, Presidential Commission for the Study of Bioethical Issues, Washington, DC
The Presidential Commission for the Study of Bioethical Issues was asked to enumerate the ethical considerations of conducting pediatric clinical trials of medical countermeasures (MCM), which are interventions to protect children in case of a terror attack. The ethical dilemma of conducting trials before an event occurs (pre-event) stems from our dual obligation to protect children in an emergency and to protect individual children, who are not ethically or legally capable to consent to accept risks on behalf of others during research. MCM research adds ethical challenges as it involves research on a hypothetical condition with an undefined, and perhaps unknowable, likelihood of occurring. Barring exceptional circumstances, ethical analysis indicates that in pre-event MCM research when there is no prospect for direct benefit, children cannot be exposed to research risks that are greater than those they would encounter in everyday life or routine medical examinations. Careful and thoughtful research design that includes informed characterization of research risks, minimization of unavoidable risk, and age de-escalation might allow for the development of minimal risk trials across the phases of childhood. The Commission further specified considerations to augment current regulatory guidance for the exceptional circumstances contemplated under section 407 in Subpart D (special protections for children) of the human research protections regulations. Concepts further specified included “reasonable opportunity” to address a “serious problem,” “sound ethical principles,” and adequate provisions for parental permission and child assent.

Learning Areas:

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

Learning Objectives:
List the ethical considerations of conducting pediatric medical countermeasure research before a terror attack occurs. Describe what characterizes minimal risk trials in pediatric medial countermeasure research.

Keyword(s): Pediatrics, Research

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am Associate Director at the Presidential Commission for the Study of Bioethical Issues. I oversaw staff work on the Bioethics Commission’s ethical analysis of pediatric medical countermeasure research and served as staff lead for the Bioethics Commission’s review of current human subjects research protections. I have published articles on various legal issues and topics in bioethics that include research ethics, end-of-life decision-making, and emerging genetic technologies.
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.