The blog of the 2009 – 2017 Presidential Commission for the Study of Bioethical Issues

Community Engagement in Pediatric Medical Countermeasure Research

The Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) recently published its report, Safeguarding Children: Pediatric Medical Countermeasure Research, in which it reviews the ethical considerations for conducting research on medical interventions that would be used to protect children in the event of a bioterror attack—also known as “medical countermeasures” (MCM). One important element of the ethical conduct of such research is community engagement.

Community engagement is a way for researchers to get feedback from the community that will be affected by the research in order to tailor the study to the community’s needs or concerns.  It also involves educating the public about the research, improving the community’s understanding of the study, and providing for more informed feedback and participation. Reaching out to marginalized communities, the general public, and other stakeholders helps to “ensure ethical study design, implementation, and access to benefits should the need arise.”

Involving the community in planning and conduct of research boosts public trust and increases the chance that individuals will recognize and take advantage of drugs or interventions that might be approved as a result of the research.  This is especially important in MCM research because the interventions under investigation are intended to mitigate harm after an emergency occurs, when time is of the essence.

The Bioethics Commission stressed that community engagement should be included in all pediatric MCM research. When research can be done before an emergency takes place (pre-event research), there is time for planning and researchers should consult the community and strive to design studies that account for the public’s concerns.

If an emergency, such as a bioterror attack, occurs before research has been completed, then medical interventions might be given to children in order to save lives, even if those interventions have only been tested in adults.  When this happens, it is important to study the safety and effectiveness of the intervention in children that receive it (post-event research). The Bioethics Commission stressed that community engagement is especially important in planning for post-event research, stating “[p]ost-event research planning should lay the groundwork for community engagement activities that can then be activated in the event of an attack.”

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This is a space for the members and staff of the 2009 -2017 Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

As of January 15th, 2017 this blog will no longer be updated but continues to be available as an archive of the work of the 2009-2017 Presidential Commission for the Study of Bioethical Issues

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