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

The Bioengineering Research Grants (BRG) (R01 Clinical Trial Optional) opportunity is offered by the Department of Health and Human Services through the National Institutes of Health (NIH). This reissue of PAR-19-159 is supported by three NIH institutes: the National Cancer Institute (NCI), the National Institute of Neurological Disorders and Stroke (NINDS), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The goal is to promote multidisciplinary collaborations between life and physical sciences to advance the development, validation, and translation of bioengineering technologies to address specific biomedical problems. The FOA is designed to support projects that apply an integrative, multidisciplinary approach to develop, optimize, or accelerate the adoption of tools, technologies, or methods in biomedical research or clinical practice. Applications can include various research strategies—design-directed, developmental, discovery-driven, or hypothesis-driven—and are particularly encouraged when proposed by small, collaborative teams. The program supports clinical trials only when functionality or performance validation in a targeted setting is proposed. Phase III clinical trials and commercial production-focused studies are not eligible under this opportunity. Eligible applicants include a wide range of U.S. and foreign entities such as higher education institutions, nonprofits, for-profit organizations including small businesses, local and state governments, and tribal governments, as well as certain federal and international bodies. The award budget is not capped but should align with the actual costs of the proposed project. The project period may span up to five years, with the number of awards contingent on available NIH appropriations and the quality of submissions. Applications must comply strictly with NIH application policies, including registration in systems such as SAM, eRA Commons, and Grants.gov. Applicants are encouraged to submit a Letter of Intent 30 days prior to each application deadline. The earliest submission date began on October 1, 2022, with standard NIH due dates recurring multiple times annually. The current expiration date for this opportunity is May 24, 2025. Applicants are required to complete and submit all necessary forms through one of the NIH’s approved platforms: ASSIST, Grants.gov Workspace, or institutional system-to-system solutions. Applications must include a detailed Research Strategy addressing how the proposed technology solves a biomedical problem, the integration of multidisciplinary approaches, a translational plan, metrics for success, and anticipated challenges. The FOA outlines comprehensive review criteria including significance, innovation, investigator capability, approach, and the scientific environment. Contacts for programmatic questions vary by NIH institute, with specific representatives listed for each participating body. Additional contacts are provided for submission support, financial inquiries, and peer review coordination. Detailed instructions, submission requirements, review considerations, and administrative policies are available in the full FOA and the NIH Grants Policy Statement.