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

Abstract

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. Our regional burn center developed and implemented a deferred consent public notification and community consultation paradigm appropriate for a burn study. 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. 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. Our communication strategy should provide a paradigm other burn centers may appropriate and adapt when planning and executing a deferred consent initiative.