In the research network’s inaugural meeting in November 2016 in Omaha, members from the 10 regional treatment centers met with federal partners from the CDC, NIAID, BARDA, and USAMRIID in order to strategize how to implement an experimental infrastructure in biocontainment units.
Working groups were launched to establish the critical research infrastructure needed to advance the understanding of the clinical syndromes and therapeutic options for outbreaks of Ebola or other special pathogens. The working group activities, which include participation from all 10 RESPTCs and multiple Federal partners, aim to:
- Engage the Regional Treatment Centers and federal partners to coordinate research initiatives for Ebola and other special pathogens through workgroups and active collaborations.
- Create a master protocol for research that allows rapid modification and review with the support of a network study coordinator.
- Operationalize a central IRB for SPRN that is located at UNMC that allows for rapid turnaround on review of protocols.
- Implement a training curriculum for research staff in a biocontainment unit using online content, available for just-in-time training.
- Establish standardized policies and procedures for the conduct of clinical research in biocontainment units.
- Create modular universal case report forms and questionnaires, based on the master protocol.
- Develop a web-based clinical data capture tool and database with capabilities to collect and coordinate data from the research network and conduct rapid analyses to provide feedback that informs therapeutics and clinical management.
- Hold an annual investigator’s meeting with clinical research teams from Regional Treatment Centers as well as other domestic and international partners in order to develop, discuss, and revise protocols and research resources.
- Customize a biorepository for special pathogen samples with BSL-3 and BSL-4 capabilities.