Through Novel Approaches for Radiation Biodosimetry and Medical Countermeasure Development (R21, Clinical Trial Not Allowed), NIAID seeks to support new exploratory and developmental research projects that focus on novel ideas in radiation research, specifically medical countermeasures (MCMs), biodosimetry, and/or animal model development to diagnose, mitigate, or treat injuries sustained during a radiation mass casualty incident.
Objectives
For all proposed studies, the selection of radiation exposure type, dose level, and dose rates should be relevant to a radiological or nuclear incident and verified by appropriate dosimetry assessments. Radiation research areas could include the following:
- Research and development of MCMs (e.g., small molecules, biologics, and cell products) for mitigation or treatment of potentially lethal acute radiation syndrome (ARS) or delayed effects of acute radiation exposure, including radiation injuries to the gastrointestinal tract, cutaneous, pulmonary, renal, cardiovascular, and/or central nervous system compartments of the body.
- Development of rapid, reliable, inexpensive, and easy-to-use biodosimetry techniques/assays and devices (e.g., triage bioassay or biomarkers).
- Development of animal models or extracorporeal radiation models (e.g., organ-on-a-chip, organoids) that are representative of adult, pediatric, and/or geriatric human populations, and take into account possible differences in drug responses between sexes in these models.
- Development of artificial intelligence/machine learning methods for the identification of novel targets and/or lead molecules for radiation injuries, the interpretation of large complex data sets, and/or data mining of new or existing databases to identify biomarkers altered by radiation exposure.
Note that we will consider applications that propose research in the following subjects nonresponsive and we will not review:
- Studies proposing to test radioprotectants (prophylactic use or administered before radiation exposure to be efficacious).
- Studies proposing the administration of a candidate MCM at times earlier than 24 hours after radiation exposure, or earlier than 48 hours after radiation exposure for MCMs targeting neutropenia or thrombocytopenia resulting from hematopoietic sub-syndrome of ARS.
- Work proposing dose ranges or exposure parameters that are not relevant to a radiation accident or attack (e.g., studies using fractionated radiation exposures, unless justified by the opportunity to collect samples from radiotherapy patients).
- Studies to investigate MCMs for injuries from thermal-only burns, radiation-induced cancers, reproductive, muscular, cataracts, or ocular damage.
- Characterization and development of biomarkers of carcinogenesis.
- Non-biologically based dosimetric methods and/or environmental testing/sampling devices (e.g., thermo-luminescent detectors, fortuitous dosimeters, and radiation portals).
- Artificial intelligence/machine learning methods that do not directly address the identification of targets/lead molecules for radiation injuries, the interpretation of large complex data sets as applied to radiation exposure/injuries, and/or data mining of new or existing databases to identify biomarkers altered by radiation exposure.
- Applications proposing HIV/AIDS studies.
- Clinical trials (all phases).
Proposed projects such as those supported through traditional R01/U01 long-term projects or those in a well-established area are not appropriate for this notice of funding opportunity (NOFO). Applications submitted to this NOFO should be exploratory and novel, breaking new ground or extending previous discoveries toward new directions or applications. Your R21 application does not require preliminary data, though you can include them. Your application may include justification through literature citations, data from other sources, or investigator-initiated data.
Be sure to read details of all scorable review criteria. For example, in addition to the standard review criteria described in the NOFO, note additional scored review criteria specific to this NOFO will assess:
- How adequate the expertise is of the key personnel in radiation biology, statistics, dosimetry, and/or health physics.
- How adequate the proposed dosimetry methods and plans are to ensure delivery of accurate radiation doses in studies for biodosimetry tools, development of MSMs, identification of biomarkers, and/or development of animal models.
- How relevant studies are with respect to the radiation doses, and how consistent the studies are with mass casualty events, related to artificial intelligence/machine learning methods or evaluation of large, complex data sets.
Award and Budget Information
We intend to fund 12 to 14 awards through this NOFO. Your total project period may not exceed 2 years, and you may request no more than $100,000 in direct costs in any single year, for a sum of $200,000 in direct costs across the 2-year project period.
Applications are due November 1, 2024, by 5:00 p.m. local time of the applicant organization.
Direct questions about this NOFO to our scientific/research contact Dr. Lanyn P. Taliaferro at lanyn.taliaferro@nih.gov or 240-669-5479. Dr. Hiten Chand can field questions about peer review at hiten.chand@nih.gov or 240-627-3245.