Bioengineering Research Grants (BRG) (R01 Clinical Trial Optional)

The Bioengineering Research Grants (BRG) (R01 Clinical Trial Optional) funding opportunity is issued by the National Institutes of Health within the U.S. Department of Health and Human Services, with participation from institutes including the National Cancer Institute, National Eye Institute, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. This program is designed to support multidisciplinary collaborations that integrate principles from engineering, physical sciences, and biomedical sciences to address complex health challenges. The initiative reflects NIH’s broader mission to advance biomedical knowledge and improve health outcomes through innovative research approaches that bridge scientific disciplines. The primary purpose of this funding opportunity is to foster the development of novel technologies, methods, models, or systems that can significantly impact biomedical research, clinical practice, or translational science. Projects are expected to apply bioengineering principles to solve defined biomedical problems, with emphasis on integrating, optimizing, validating, and translating promising tools or techniques. The program encourages research that is design-directed, developmental, discovery-driven, or hypothesis-driven, provided it demonstrates a clear multidisciplinary approach and potential for meaningful advancement in understanding or treating health conditions. Funding supports a wide range of activities including development of diagnostic tools, computational models, imaging technologies, delivery systems, and other innovations that improve measurement sensitivity, clinical interventions, or healthcare delivery. While clinical trials are permitted if they are focused on validating performance or functionality, the program explicitly excludes large-scale phase III trials and projects lacking a translational component. Additionally, the funding does not support commercial production activities, reinforcing its focus on research and development rather than commercialization. Eligible applicants include a broad spectrum of organizations such as higher education institutions, nonprofit organizations, for-profit entities, government agencies at various levels, and international organizations. The program allows both domestic and non-domestic applicants, although restrictions apply to foreign subawards. Individual principal investigators must demonstrate the expertise and resources necessary to carry out the proposed work and must be affiliated with an eligible organization. Required registrations include SAM, Grants.gov, and eRA Commons, and applicants must follow NIH application guidelines strictly to ensure compliance. Applications are submitted electronically through NIH-approved systems such as ASSIST, Grants.gov Workspace, or institutional system-to-system solutions. Required components include detailed research plans, budgets, data management and sharing plans, and compliance with NIH formatting and submission requirements. Applications undergo rigorous peer review based on criteria such as significance, innovation, rigor, feasibility, and investigator expertise. Additional considerations include human subjects protections, inclusion plans, and overall project impact. The funding opportunity follows standard NIH submission cycles with multiple due dates annually. The earliest submission date is September 5, 2026, with subsequent deadlines occurring in October, February, and June cycles each year through 2029. Awards are contingent on available funding and the merit of submitted proposals, with project periods of up to five years and budgets limited to less than $500,000 in direct costs per year. The program is recurring, providing ongoing opportunities for applicants to submit proposals aligned with NIH priorities.

Emphasize multidisciplinary integration strong engineering approach and clear translational impact aligned with NIH priorities