A burn center paradigm to fulfill deferred consent public disclosure and community consultation requirements for emergency care research

Introduction: To fulfill Food and Drug Administration and Department of Health and Human Services emergency care research informed consent requirements, our burn center planned and executed a deferred consent strategy gaining Institutional Review Board (IRB) approval to proceed with the clinical study. These federal regulations dictate public disclosure and community consultation unique to acute care research.

Objective: Our regional burn center developed and implemented a deferred consent public notification and community consultation paradigm appropriate for a burn study.

Methods: Published accounts of deferred consent strategies focus on acute care resuscitation practices. We adapted those strategies to design and conduct a comprehensive public notification/community consultation plan to satisfy deferred consent requirements for burn center research.

Results: To implement a robust media campaign we engaged the hospital's public relations department, distributed media materials, recruited hospital staff for speaking engagements, enlisted community volunteers, and developed initiatives to inform "hard-to-reach" populations. The hospital's IRB determined we fulfilled our obligation to notify the defined community.

Conclusion: Our communication strategy should provide a paradigm other burn centers may appropriate and adapt when planning and executing a deferred consent initiative.