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09/09/2015

Bioethics Deliberation and Education in Safeguarding Children

In the most recent post for the “Deliberation and Education” series, we examined the role of deliberation in the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) fourth report Privacy and Progress in Whole Genome Sequencing. While not specifically citing democratic deliberation in its recommendations in Privacy and Progress, the Bioethics Commission actively demonstrated the principle by inviting experts from the public and private sectors to inform their public deliberations on the topic. The fifth post in the series will examine deliberation and education in the Commission’s fifth report: Safeguarding Children: Pediatric Medical Countermeasure Research.

At the request of the Secretary for Health and Human Services, the Bioethics Commission conducted a careful and transparent review of the ethical considerations of conducting medical countermeasure (MCM) research with children.

Safeguarding Children, published in March 2013, is the Bioethics Commission’s response to this request. In this report, the Commission made six recommendations concerning MCM research with children, differentiating between pre-event (before exposure to an agent) and post-event (after exposure) research. The Commission identified four ethical principles to guide their discussion of pediatric research protections: respect for persons, beneficence, justice, and democratic deliberation. The Commission recognized that in research, one example of democratic deliberation is community engagement—the process of including community members in an ongoing public exchange of ideas. Democratic deliberation can also be present in various aspects of institutional research review and approval. The Commission referenced community engagement and democratic deliberation in its recommendations for both pre- and post-event research.

In its fourth recommendation, the Bioethics Commission included community engagement in its recommended ethical framework for national-level review of pre-event research that poses more than minimal risk without a prospect of direct benefit. Through this framework, the Commission sough to specify a rigorous set of conditions necessary to determine whether research is conducted in accordance with “sound ethical principles”—a regulatory requirement for this exceptional type of research.

The Bioethics Commission determined that community engagement would be particularly important in a post-event scenario, when it’s necessary to educate the public about research, allow them to inform the researchers about their concerns, and encourage the public to utilize the results of the research. The Commission recommended that, for post-event research:

… Institutional review boards must also ensure that…provisions are made to engage communities throughout the course of research.

Both recommendations described here reflect the Bioethics Commission’s emphasis on the importance of democratic deliberation and its practical implementation. By engaging the community throughout the research process—be it pre- or post-event—researchers can ensure that the public remains aware of what is occurring, while the community can guarantee that its voices and concerns are being heard.

Safeguarding Children and all other Bioethics Commission reports are available at bioethics.gov.

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