Development of Alternative Human Models of Radiation-Induced Injuries (Extracorporeal Systems) (U01 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), through the National Institute of Allergy and Infectious Diseases (NIAID), has issued a Notice of Funding Opportunity (NOFO) titled "Development of Alternative Human Models of Radiation-Induced Injuries (Extracorporeal Systems)." This opportunity, funded as a U01 Cooperative Agreement, seeks proposals to develop alternative human models (extracorporeal systems) that can replicate acute and delayed radiation-induced injuries, particularly for understanding injury mechanisms and testing medical countermeasures (MCMs). These alternative human models are intended to provide research tools that can be used in place of in vivo animal models, offering an ethical and effective pathway to study human responses to radiological or nuclear exposure. The primary goal of this funding opportunity is to advance early- to mid-stage research focused on extracorporeal systems capable of mimicking human responses to radiation exposure, such as tissue chips, bioprinted organ models, and ex vivo organ cultures. Projects may include research on acute radiation syndrome (ARS) and delayed effects of acute radiation exposure (DEARE), targeting organ systems like the gastrointestinal, pulmonary, cardiovascular, renal, and central nervous systems. Additionally, proposals can include plans for testing the efficacy of MCMs when administered at least 24 hours post-exposure (48 hours for H-ARS treatments like those addressing neutropenia or thrombocytopenia). All proposed studies should prioritize relevance to mass radiological or nuclear incident response. This NOFO has a total funding allocation of $4 million for fiscal year 2026, with anticipated awards ranging between six and eight projects. Each application can request up to $350,000 per year in direct costs for a maximum project period of five years. Eligible applicants include U.S.-based higher education institutions, nonprofits, for-profit entities, and government organizations. Foreign organizations are not eligible, but foreign components as part of U.S.-based organizations are allowed. Cost-sharing is not required for this NOFO. Applications are due by February 6, 2025, and must be submitted through Grants.gov. A letter of intent is encouraged 30 days before the application due date. Required submission materials include a detailed research strategy with specific, measurable milestones for each project year, budget information, a data management and sharing plan, and compliance with SAM.gov and eRA Commons registration requirements. Applications must also include biosketches emphasizing relevant expertise in radiation biology, dosimetry, and health physics. Applications that do not focus on human-based extracorporeal models or that lack preliminary data and clear milestones will be considered non-responsive. Review criteria will evaluate the significance, innovation, and feasibility of the proposed research, with particular attention to the rigor of study design, potential for reproducible data, and appropriateness of resources and personnel. NIAID expects to work closely with recipients under this cooperative agreement, including guidance on technical issues, dosimetry harmonization, and collaboration with other awardees. Selected recipients will also be required to participate in an annual program progress meeting to be held in Rockville, MD. Questions can be directed to NIAID contacts, with contact information provided in the NOFO for scientific, peer review, and grants management inquiries. Award notifications will follow peer and advisory council reviews, and all awards will be subject to NIH policies as outlined in the NIH Grants Policy Statement.