Developing a Rapid Response Single IRB Model for Conducting Research During a Public Health Emergency.

Research is foundational for evidence-based management of patients. Clinical research, however, takes time to plan, conduct, and disseminate-a luxury that is rarely available during a public health emergency. The University of Nebraska Medical Center (UNMC) developed a single institutional review board (IRB), with a vision to establish a rapid review resource for a network focused on clinical research of emerging pathogens in the United States. A core aspect of successful initiation of research during a pandemic or epidemic is the ability to operationalize an approach for rapid ethical review of human subject research and conduct those reviews at multiple sites-without losing any of the substantive aspects of ethics review. This process must be cultivated in anticipation of a public health emergency. US guidance for operationalizing IRB review for multisite research in a public health emergency is not well studied and processes are not well established. UNMC sought to address operational gaps and identify the unique procedural needs of rapid response single IRB (RR-sIRB) review of multisite research by conducting a series of preparedness exercises to develop and test the RR-sIRB model. For decades, emergency responder, healthcare, and public health organizations have conducted emergency preparedness exercises to test requirements for emergency response. In this article, we describe 2 types of simulation exercises conducted by UNMC: workshops and tabletops. This effort represents a unique use of emergency preparedness exercises to develop, refine, and test rapid review functions for an sIRB and to validate readiness of regulatory research processes. Such processes are crucial for conducting rapid, ethical, and sound clinical research in public health emergencies.

Advanced Preparation Makes Research in Emergencies and Isolation Care Possible: The Case of Novel Coronavirus Disease (COVID-19).

The optimal time to initiate research on emergencies is before they occur. However, timely initiation of high-quality research may launch during an emergency under the right conditions. These include an appropriate context, clarity in scientific aims, preexisting resources, strong operational and research structures that are facile, and good governance. Here, Nebraskan rapid research efforts early during the 2020 coronavirus disease pandemic, while participating in the first use of U.S. federal quarantine in 50 years, are described from these aspects, as the global experience with this severe emerging infection grew apace. The experience has lessons in purpose, structure, function, and performance of research in any emergency, when facing any threat.

Utilization of Functional Exercises to Build Regional Emergency Preparedness among Rural Health Organizations in the US.

Rural communities face barriers to disaster preparedness and considerable risk of disasters. Emergency preparedness among rural communities has improved with funding from federal programs and implementation of a National Incident Management System. The objective of this project was to design and implement disaster exercises to test decision making by rural response partners to improve regional planning, collaboration, and readiness. Six functional exercises were developed and conducted among three rural Nebraska (USA) regions by the Center for Preparedness Education (CPE) at the University of Nebraska Medical Center (Omaha, Nebraska USA). A total of 83 command centers participated. Six functional exercises were designed to test regional response and command-level decision making, and each 3-hour exercise was followed by a 3-hour regional after action conference. Participant feedback, single agency debriefing feedback, and regional After Action Reports were analyzed. Functional exercises were able to test command-level decision making and operations at multiple agencies simultaneously with limited funding. Observations included emergency management jurisdiction barriers to utilization of unified command and establishment of joint information centers, limited utilization of documentation necessary for reimbursement, and the need to develop coordinated public messaging. Functional exercises are a key tool for testing command-level decision making and response at a higher level than what is typically achieved in tabletop or short, full-scale exercises. Functional exercises enable evaluation of command staff, identification of areas for improvement, and advancing regional collaboration among diverse response partners. Obaid JM , Bailey G , Wheeler H , Meyers L , Medcalf SJ , Hansen KF , Sanger KK , Lowe JJ . Utilization of functional exercises to build regional emergency preparedness among rural health organizations in the US. Prehosp Disaster Med. 2017;32(2):224-230.

A 3-year Health Care Coalition Experience in Advancing Hospital Evacuation Preparedness.

This report outlines a 3-year health care coalition effort to advance and test community capacity for a large-scale hospital evacuation. The multi-year effort utilized a variety workshops, seminars, webinars, tabletops, functional exercises, and culminated with a full-scale exercise testing hospital evacuation. While most hospital evacuation exercises focus on internal movement of patients, this exercise process tested command-level decision making and it tested external partners such as transportation agencies, law enforcement, receiving hospitals, and local emergency management. This process delivered key coalition-building activities and offered a variety of training and exercise opportunities to assist a number of organizations, all at different stages of hospital evacuation planning. The 2012 Hospital Preparedness Program outlined the incorporation of health care coalition activities to transform individual organization preparedness to community-level readiness. This report outlines a health care coalition effort to deliver training and exercises to advance community capacity for a large-scale hospital evacuation. Lowe JJ , Hansen KF , Sanger KK , Obaid JM . A 3-year health care coalition experience in advancing hospital evacuation preparedness. Prehosp Disaster Med. 2016;31(6):658-662.