Human Virome Characterization Centers (U54 Clinical Trial Not Allowed) | RFA RM 23 019

Opportunity Information: Apply for RFA RM 23 019

The Human Virome Characterization Centers opportunity (RFA-RM-23-019) is a National Institutes of Health (NIH) Common Fund initiative that will support the creation of large, multicomponent “Virome Centers” using the U54 cooperative agreement mechanism. The central goal is to map, identify, and deeply characterize the human virome (the collection of viruses associated with the human body) by studying people over time and intentionally including diverse participants. The program emphasizes longitudinal cohort work and sampling across multiple body sites and tissues, recognizing that viral communities can differ by location in the body and can change with time, environment, age, immune status, and other factors.

A defining feature of this funding opportunity is the required multicore center structure. Each center is expected to bring together specialized expertise and coordinated operations to handle the full pipeline of virome research at scale. That includes recruiting and retaining diverse cohorts; collecting many different types of biospecimens; isolating and detecting viruses in multiple biological states (including circulating viruses as well as proviral and integrated forms); and generating standardized, high-quality datasets that can be compared across centers and over time. The intent is not just to find viral sequences, but to produce rigorous characterization supported by strong methods, consistent protocols, and robust analysis approaches that can withstand cross-site comparisons.

The centers are also expected to address the ethical, social, and legal implications (often referred to as ELSI) that come with human virome research. This reflects practical realities: virome data can intersect with privacy risks, questions about returning results, incidental findings, stigma, and community concerns, especially when working with diverse populations and sensitive health contexts. In addition to scientific and technical cores, the program anticipates well-developed approaches for responsible data practices, participant protections, and community-aware research conduct, aligned with NIH expectations for human subjects protections and data stewardship.

Because this is a cooperative agreement (U54), NIH will have substantial involvement in program coordination compared to a standard research grant. The funded centers will be expected to collaborate as part of a larger consortium that also includes separately funded investigative teams. Beyond producing center-specific outputs, awardees will participate in joint governance and coordination activities, helping to develop and follow shared consortium policies, practices, and standards. This collaborative model is meant to accelerate progress by aligning methods, enabling pooled analyses, and reducing fragmentation across sites and teams.

The announcement also notes that these virome centers have unique objectives, core specifications, and review criteria that are tailored to this complex, center-based program. NIH explicitly points out that there are not existing standing study sections with the breadth of expertise needed to evaluate applications of this type, which signals that review will be organized specifically to match the program’s interdisciplinary scope (spanning virology, genomics, bioinformatics, clinical sampling, cohort operations, data standards, and ELSI).

On eligibility, the opportunity is broadly open across many organization types, including state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) as well as small businesses; independent school districts; and various other entities. The RFA explicitly calls out additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, it restricts non-U.S. applicants: non-domestic (non-U.S.) entities and non-U.S. components of U.S. organizations are not eligible to apply. However, “foreign components” as defined by the NIH Grants Policy Statement are allowed, which typically means a U.S.-based applicant can include certain well-justified international elements in the project under NIH rules, even though the prime applicant must be domestic.

Administratively, the opportunity falls under the NIH funding activity category of Health and uses the cooperative agreement funding instrument. The Assistance Listing (CFDA) number is 93.310. The posting lists an original closing date of November 17, 2023, and a creation date of September 13, 2023. The title specifies “Clinical Trial Not Allowed,” indicating the program is not intended to support clinical trials as defined by NIH, even though it will involve human participants, longitudinal follow-up, and biospecimen collection for observational characterization work.

In practical terms, an applicant for this RFA would be expected to propose an integrated center capable of running coordinated cohort-based virome science end to end: participant recruitment and retention, multi-site sampling and processing, advanced viral detection and characterization (including difficult-to-capture viral forms), standardized data generation and analysis, strong data sharing and harmonization practices across the consortium, and a serious, operational plan for ELSI challenges. The overall emphasis is building shared infrastructure and knowledge that can define what “normal” and “variable” looks like in the human virome across populations, body sites, and time, while creating program-wide standards and resources that other researchers can build on.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Human Virome Characterization Centers (U54 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310.
• This funding opportunity was created on 2023-09-13.
• Applicants must submit their applications by 2023-11-17. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA RM 23 019

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: