Earlier today the Presidential Commission for the Study of Bioethical Issues released its report on pediatric medical countermeasures research (H/T ScienceInsider). Titled Protecting Children, the report reflects the Commission’s deliberations on the subject over the past 15 months (prompted by recommendations from the National Biodefense Science Board. Commission Chair Amy Gutmann has a Perspectives column in The New England Journal of Medicine on the subject.
Many challenges with research on medical countermeasures for children have to do with issues of consent. Because of their age, children cannot legally give informed consent, and if the research is not likely to present significant benefits to the research subjects, the risk they should be expected to accept should be minimized. But there has been no documented research on the use of current anthrax vaccines on children, leaving us unprepared in the instance of a widespread release of the virus.
The report focuses on two kinds of medical countermeasures research: pre- and post-event. The event in question is exposure to the biological agent. The distinction is critical from an ethical perspective because the obligations to the research subjects shift. In a pre-event research scenario, there has been no exposure to the virus, meaning the threshold of risk exposure needs to be lower to correspond with the reduced (or nil) benefit to the research subjects. Post-event research would help the research subjects as they have been exposed to the agent, and higher levels of risk are considered acceptable in those situations.
The bulk of the report’s recommendations set forth the appropriate review mechanism and standards of harm that it considers appropriate for pre- and post-event medical countermeasure research. Many of these recommendations speak to the relevant federal regulations on human subjects research for children. A good summary of the Commission’s findings and recommendations can be found in Dr. Gutmann’s Perspectives column.
The Commission’s next meeting will be at the end of April in Washington, D.C. While no draft agenda is released as of this writing, guidance on incidental findings is a project the Commission has announced its interest in pursuing.
Pasco Phronesis 