Pilot Projects to Enhance the Human Virome Program (R03, Clinical Trials Not Allowed)

The U.S. Department of Health and Human Services, through the National Institutes of Health, has released a Notice of Funding Opportunity titled Pilot Projects to Enhance the Human Virome Program (R03, Clinical Trials Not Allowed). This initiative is part of the NIH Common Fund, overseen by the Office of Strategic Coordination. The program will be administered by the National Institute of Dental and Craniofacial Research. The Human Virome Program seeks to comprehensively characterize the human virome, encompassing all viruses present in or on humans, both eukaryotic and prokaryotic. The goal is to develop tools, models, and methods that allow for deeper study of virome dynamics, interactions with the host, and potential influence on human health. The pilot projects supported under this funding opportunity are intended to complement and extend existing Human Virome Program initiatives. They include validating and improving tools developed within the program, using human and animal samples to refine approaches, expanding biospecimen sources, and defining virome-host interactions. Importantly, projects may not duplicate or overlap with existing efforts. The R03 mechanism is designed to support smaller-scale projects that can be completed within a limited budget and timeframe. This initiative emphasizes collaboration across the HVP consortium and requires funded investigators to actively participate in consortium meetings and working groups. Applications must focus on enhancing tools and methods for virome research, addressing methodological challenges, or exploring functional interactions between the virome, microbiome, and human host. Proposals narrowly focused on specific pathogenic viruses or disease states will not be considered responsive. All projects must ultimately contribute to the overarching goal of understanding the human virome’s role in human health. Outcomes are expected to support the creation of a comprehensive human virome atlas and provide foundational resources for future biomedical research. The NIH Common Fund intends to allocate approximately $2 million in Fiscal Year 2026 to support around six awards under this opportunity. Each award is capped at $100,000 in direct costs per year for a maximum project period of two years, though all funds will be disbursed in the first year. Clinical trials are not permitted under this NOFO. Applications must be submitted electronically through NIH ASSIST, Grants.gov Workspace, or institutional system-to-system solutions. Applicants must comply fully with NIH application guides, including data management and sharing plans. Non-compliant or incomplete applications will not be reviewed. Eligible applicants include U.S.-based higher education institutions, nonprofits, for-profit organizations, small businesses, and various levels of government including state, local, and tribal entities. Foreign organizations are not eligible, and NIH has recently restricted the use of foreign subawards and subcontracts. Applicants must ensure all required registrations are in place prior to submission, including SAM, UEI, Grants.gov, and eRA Commons. Applications must designate a Program Director/Principal Investigator with an eRA Commons ID. NIH intramural scientists may participate under specific cost conditions. The application window opens on October 24, 2025, and the deadline for submission is November 24, 2025, by 5:00 PM local time. Late applications will not be accepted. Applications will undergo peer review in March 2026, advisory council review in May 2026, and earliest awards are expected by July 2026. Applications will be reviewed on three main factors: importance of the research, rigor and feasibility of the approach, and expertise and resources of the investigator and institution. Reviewers will also assess protections for human subjects, animal welfare, and data management. Contacts for this opportunity include Roberto Flores-Munguia, PhD, MPH, at the National Institute on Aging for scientific inquiries (floresr2@nih.gov, 301-827-4766), Gabriel Hidalgo, MBA, at the National Institute of Dental and Craniofacial Research for grants management (gabriel.hidalgo@nih.gov, 301-827-4630), and the Center for Scientific Review for peer review contact (FOAReviewContact@csr.nih.gov). Applicants may also seek technical support through the eRA Service Desk and Grants.gov help desk. The funding opportunity expires on November 25, 2025.