In an effort to accelerate the development of approaches to diagnose, treat, and mitigate injuries resulting from mass casualties, radiological, or nuclear incidents, NIAID has issued a notice of funding opportunity (NOFO), Development of Alternative Human Models of Radiation-Induced Injuries (Extracorporeal Systems) (U01, Clinical Trial Not Allowed). The NOFO supports early- to mid-stage research and development of extracorporeal systems that mimic human responses and test appropriate medical countermeasures (MCMs) to treat civilian populations in case of a radiological or nuclear accident or attack.
Research Objectives
Research activities carried out as part of this effort may include mechanism of tissue injury studies, testing of candidate MCMs to advance product development, development of novel extracorporeal systems, or advancement of existing systems such as human or animal platforms in early stages of development that are being used for radiation research or other indications.
To that end, applications should either include a plan that develops or advances an extracorporeal human model system that bridges biomarkers from animals to humans; or testing of a single or multiple MCMs that use the developed human model to simulate human responses to the MCMs; or both. Investigators must make sure to select a radiation exposure type, dose level, and dose rate that’s relevant to a radiological or nuclear incident and verified by appropriate dosimetry assessments. Animal ex vivo models are permitted for study only if they are being used in addition to human models and are needed to bridge between in vivo animal and ex vivo human findings.
Note that applicants proposing to test an MCM in the developed human extracorporeal model must administer the MCM at least 24 hours or more following radiation exposure. MCMs targeting hematopoietic acute radiation syndrome (H-ARS) for neutropenia or thrombocytopenia must be administered 48 hours or later post-radiation exposure.
The Research Strategy must include annual milestones for the first year of the project and brief milestones for additional years that may be negotiated annually. NIAID staff will use these milestones to assess annual progress and support funding decisions. Applications without milestones will be considered nonresponsive and will not be reviewed.
Refer to the NOFO for specifics on areas of research that will be considered nonresponsive and will not be reviewed.
Budget Information and Eligibility
NIAID will fund six to eight awards in fiscal year 2026. Application budgets are not expected to exceed $350,000 in direct costs per year and should reflect the actual needs of the proposed project. While the scope of the proposed project should determine the project period, the maximum project period is 5 years.
The deadline to apply is February 6, 2025. Note that applicants will need to use FORMS-I for this opportunity. While the updated forms are not yet available, they will be posted 30 calendar days or more before the application due date.
Foreign organizations and components as well as non-U.S. components of U.S. organizations are not eligible to apply for this NOFO.
Contact Information
For more information, contact Dr. Carmen Rios, NIAID’s scientific/research contact, at carmen.rios@nih.gov or 240-627-3553. For peer review-related inquiries, contact Dr. Hiten Chand, NIAID’s peer review contact, at hiten.chand@nih.gov or 240-627-3245.