36 - The Special Pathogens Research Network Single IRB: Findings from the 2024 Marburg Virus Disease Outbreak

Background: : University A and the Special Pathogens Research Network (SPRN) partnered to support IRB review of clinical research for 14 US sites during a public health emergency. This partnership leveraged a rapid response IRB, connections with federal agencies and sponsors, and a workgroup of local IRBs.

Program

Description: : In 2024, SPRN undertook a preparedness initiative with the Biomedical Advanced Research and Development Authority (BARDA) and a pharmaceutical sponsor to approve an Expanded Access Protocol (EAP) for an investigational therapy for Marburg virus disease (MVD) using a single IRB. MVD is considered a national security threat, and BARDA has been working with partners to develop investigational treatments. The program was designed to secure approvals through single IRB review in advance of a MVD outbreak or a suspect case that presents in the US. The program launch coincided with the 2024 MVD outbreak and required a hybrid approach to review—initiating rapid response single IRB review at the lead site and prioritizing the review of participating sites most likely to receive patients, which was followed by transitioning to a standard review process for the addition of participating sites once the outbreak was no longer an immediate threat.

Program

Assessment: : The roll out of the EAP in response to a real world threat required an integrated communications strategy across multiple organizations (SPRN, reviewing IRB, sponsor, and relying sites) and convening the SPRN workgroup of local IRBs to address challenges with local HRPP review, conducting working sessions with the participating site teams to facilitate submission to the single IRB electronic system, and coordination with BARDA and the sponsor on the global research priorities. The findings will include the following:

• The importance of preparedness exercises in evaluating rapid review processes.
• The significance of having a workgroup with members from participating site IRBs convened in advance to support local requirements in a public health emergency, and the process of including them as members of SPRN.
• A proactive communication strategy and tools to strengthen coordination with a range of relevant stakeholders.
• Lessons learned in maintaining flexibility to accommodate site-specific needs while preserving the integrity of centralized ethical and regulatory oversight.

The findings also provide key considerations for integrating a sIRB into a research network.

Limitations:: While the sIRB model improved approval times, challenges remained in harmonizing local context considerations and institutional policies across diverse sites. Feedback from study teams highlighted difficulties encountered when navigating a homegrown IRB submission platform, which limited user familiarity and required additional support from the SPRN team. Additionally, delays stemming from contracting complexities—or the absence of pre-established agreements—underscored the need to evaluate the contracting complexities common for an EAP.

Discussion: : The SPRN sIRB serves as a model for enhancing research readiness during public health emergencies. By centralizing ethical reviews, integrating IRBs into preparedness activities, and fostering inter-institutional collaboration, the sIRB can flex to the demands of the emergency and support network research priorities. The onboarding of an EAP for MVD provides a case study of the SPRN sIRB detailing preparedness and response efforts necessary to conduct clinical research alongside response efforts. Future efforts should focus on local context adaptations, preparedness exercises to plan for operational and ethical concerns, and process refinement to support investigational therapy deployment in emergency scenarios.