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

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Description

This opportunity from the National Institutes of Health (NIH) encourages collaborative, multidisciplinary research that applies bioengineering approaches to solve biomedical problems. The program aims to foster the development, integration, optimization, validation, and translation of innovative tools, methods, and techniques for specific research or clinical challenges in basic, translational, or clinical science.

Projects may be design-directed, developmental, discovery-driven, or hypothesis-driven, and are particularly suitable for small teams using integrative approaches. The focus is on advancing understanding and providing solutions in biological, clinical, or translational science by leveraging principles from quantitative sciences (e.g., engineering, physics, mathematics, computer science, chemistry) in combination with biomedical research.

The program will support clinical trials that test functionality or validate performance in the intended setting, but will not support conventional or late-phase (phase III) clinical trials.

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Due Dates

• New Applications: June 5, 2025
• Renewal/Resubmission/Revision Applications: July 5, 2025
• AIDS Applications: September 7, 2025

All applications are due by 5:00 PM local time of the applicant organization. Letters of intent are due 30 days prior to the application due date.

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Funding Amount

• Budget: No specific budget limit; budgets must be justified by the scope and needs of the proposed project.
• Project Period: Up to 5 years, depending on the policy of the relevant NIH Institute or Center.
• Number of Awards: Contingent on NIH appropriations and the number of meritorious applications.

Applicants requesting $500,000 or more in direct costs in any year must contact a Scientific/Research Contact at least 6 weeks before submission.

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Eligibility

Eligible applicants include:

• Public and private institutions of higher education
• Nonprofits with or without 501(c)(3) status (other than institutions of higher education)
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Independent school districts
• Public housing authorities/Indian housing authorities
• Native American tribal governments (federally recognized and other)
• Native American tribal organizations (other than federally recognized)
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions
• Non-domestic (non-U.S.) entities (foreign organizations) and foreign components of U.S. organizations

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as a Program Director/Principal Investigator (PD/PI) may apply.

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
• Required Registrations: Applicant organizations must register with SAM, Grants.gov, and eRA Commons. PDs/PIs must have an eRA Commons account.
• Application Guide: Follow the SF424 (R&R) Application Guide and the specific instructions in the funding announcement.
• Data Management and Sharing Plan: Required for all applications.
• Page Limits: As described in the SF424 Application Guide.
• Contact NIH Scientific/Research staff if requesting $500,000 or more in direct costs in any year.

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Additional Information

• Clinical Trials: Optional. The FOA supports clinical trials that test or validate new tools or methods, but not conventional or phase III trials.
• Review Criteria: Scientific merit, innovation, significance, investigator qualifications, approach, and environment.
• Foreign Institutions: Eligible to apply; must follow NIH policies for foreign applicants.
• Cost Sharing: Not required.
• Multiple Applications: Allowed if each is scientifically distinct.

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External Links

• NIH Funding Announcement (PAR-22-243)
• NIH Grants Policy Statement
• NIH Standard Due Dates
• Apply via Grants.gov
• NIH Application Guide (SF424 R&R)

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Contact Information

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