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

The Bioengineering Research Grants program is a federal research funding opportunity administered by the National Institutes of Health within the Department of Health and Human Services. Participating NIH components include the National Cancer Institute, National Eye Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and National Institute of Neurological Disorders and Stroke. The opportunity uses the R01 Research Project Grant activity code and is identified as PAR-27-072. Its central goal is to foster innovative technologies, models, techniques, designs, or methods that can significantly affect biomedical research by integrating principles and concepts from quantitative sciences with biological, clinical, and translational research. The program encourages multidisciplinary collaborations between the life and physical sciences that apply bioengineering approaches to biomedical problems and integrate, optimize, validate, translate, or accelerate the adoption of promising tools, methods, and techniques. Projects may be design-directed, developmental, discovery-driven, or hypothesis-driven and are intended for small teams using integrative approaches. Examples include validation and translation of tools for prevention, monitoring, or intervention; quantitative predictive models of complex biological systems; integration and optimization of measurement technologies; engineering and testing of delivery systems, tissues, therapeutics, implants, and prosthetics; imaging technologies; computational modeling and artificial intelligence enabled tools; and other technologies relevant to the missions of participating NIH Institutes and Centers. Clinical trials are optional. The program can support clinical trials that test functionality or validate performance in the selected setting, but it is not intended for conventional clinical trials lacking translation as their primary motivation. Late-phase or randomized clinical trials and phase III clinical trials are not responsive. Projects that merely pursue biological or clinical hypotheses without technology development, use existing technologies without necessary modification or adaptation, or conduct traditional biological hypothesis-driven research using unmodified technologies are also nonresponsive. Commercial production is not supported. Application budgets must be less than 500000 dollars in direct costs per year. The project scope should determine the project period, with a maximum award period of five years depending on the policy of the participating NIH Institute. Cost sharing is not required. Eligible applicants include public and private institutions of higher education, nonprofit organizations with or without 501(c)(3) status, small businesses, other for-profit organizations, state governments, county governments, city or township governments, special district governments, federally recognized and other tribal governments, eligible federal agencies, independent school districts, public and Indian housing authorities, Native American tribal organizations, faith-based and community-based organizations, regional organizations, and foreign organizations. Non-U.S. components of U.S. organizations may apply, but foreign components are not allowed. Foreign subawards and subcontracts are prohibited under this NOFO. Applicant organizations must maintain the required SAM, UEI, eRA Commons, and Grants.gov registrations. All PDs and PIs must have eRA Commons accounts and be registered with ORCID. Applications must follow the Research instructions in the NIH How to Apply Application Guide and applicable program-specific instructions. Applications may be prepared and submitted through NIH ASSIST, an institutional system-to-system solution, or Grants.gov Workspace, with eRA Commons used for tracking. The Research Strategy must explain how the proposed technology addresses an unmet human health need, how engineering, physical science, computational, or other multidisciplinary concepts will address the biomedical problem, the plan for advancing the solution and potential adoption by end users, and anticipated risks and limitations. A Data Management and Sharing Plan is required when the research will generate scientific data. Human subjects and clinical trial documentation is required when applicable. Paper applications are not accepted. Applications are evaluated through NIH peer review for scientific and technical merit. Review factors address the importance of the research, including significance and innovation; rigor and feasibility of the approach; and investigator expertise and institutional resources. Program-specific considerations include whether the project develops, optimizes, or validates quantitative methods, technologies, or tools; whether integration creates new capabilities; whether engineering, computational, and physical science approaches are appropriately integrated; and whether resources support a multidisciplinary approach. Funding decisions also consider scientific and technical merit, availability of funds, and relevance to program priorities. Recommended applications receive a second level of review, and successful applicants receive an official Notice of Award. The opportunity was posted May 4, 2026, and opens for submissions September 5, 2026. Standard new application deadlines begin October 5, 2026, while renewal, resubmission, and revision deadlines begin November 5, 2026, with additional recurring NIH standard due dates through July 5, 2029. Applications are due by 5:00 PM local time of the applicant organization, subject to NIH rules for weekends and federal holidays. The opportunity expires July 6, 2029. Scientific inquiries may be directed to the participating Institutes, including bioengineeringresearchgrants@mail.nih.gov for NCI, NEI_extramural@nih.gov for NEI, rehabilitation1@mail.nih.gov for NICHD, and NINDSBRG@ninds.nih.gov for NINDS. NCI financial and grants management inquiries may be directed to NCIFinancialContact@nih.gov or 240-276-6291.

Clearly identify an important biomedical problem and unmet need and show substantive technology development, optimization, or validation rather than traditional hypothesis-driven research using unmodified technology. Demonstrate meaningful integration of engineering, computational, physical science, and biomedical approaches. Provide a rigorous and feasible research plan, appropriate controls and analysis, justified resources, and multidisciplinary arrangements. Address translation, dissemination, adoption by end users, risks, and limitations where relevant. Submit early enough to identify and correct electronic submission errors before the deadline.