Figure 1.

Relationship-based model (RBM) for community and regulatory engagement. Venn diagram showing interactions among key components applying a RBM. Stakeholders and community members are at the center and drive decision-making processes. Research (RES)/Regulation (REG): Dialogue among researchers and regulators is critical in the assessment of risk, application of the technology, and monitoring and surveillance. REG/Stakeholder and Community Engagement (SE & CE): Dialogue among regulators, stakeholders, and community members informs and guides the risk assessment and regulatory development processes, monitoring, and surveillance. RES/SE & CE: Dialogue among researchers, stakeholders, and community will direct the scientific research and timelines and will determine if, when, where, and how the technology is applied.