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.
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Human Virome Characterization Centers (RFA-RM-23-019) - FAQs

What is the Human Virome Characterization Centers opportunity (RFA-RM-23-019)?

This opportunity is a National Institutes of Health (NIH) Common Fund initiative to support the creation of large, multicomponent "Virome Centers" through the U54 cooperative agreement mechanism. The program is designed to map, identify, and deeply characterize the human virome by studying people over time and intentionally including diverse participants.

What is the main goal of the program?

The central goal is to map, identify, and deeply characterize the human virome (the collection of viruses associated with the human body). The program emphasizes understanding how viral communities vary across body sites and tissues and how they change over time due to factors such as environment, age, immune status, and other influences.

What does "human virome" mean in this announcement?

In this context, the human virome refers to the collection of viruses associated with the human body. The program focuses on detecting and characterizing viruses across multiple body locations and over time, recognizing that viral communities can differ by site and shift longitudinally.

What funding mechanism is used for these awards?

The funding mechanism is a U54 cooperative agreement. This is a center-based award structure where NIH has substantial involvement in program coordination compared to a standard research grant.

What does it mean that this is a "cooperative agreement" (U54)?

Because the award is a cooperative agreement, NIH will have substantial involvement in coordinating the overall program. Funded centers are expected to collaborate as part of a broader consortium, participate in joint governance and coordination activities, and help develop and follow shared consortium policies, practices, and standards.

What type of research approach does the program emphasize?

The program emphasizes longitudinal cohort research, meaning participants are studied over time. It also emphasizes sampling across multiple body sites and tissues to capture how viromes vary across locations and change longitudinally.

Why is longitudinal sampling important for this program?

The announcement highlights that viral communities can change with time and can be influenced by factors like environment, age, immune status, and other variables. Longitudinal sampling is therefore central to building an accurate understanding of what is normal, what is variable, and how the virome shifts across time and populations.

Why does the program require sampling across multiple body sites and tissues?

The program recognizes that viral communities can differ depending on where they are found in the body. Sampling across multiple body sites and tissues is emphasized to capture location-specific differences and to support rigorous comparisons across people and over time.

What is a defining structural requirement for applicants?

A defining feature is the required multicore center structure. Each funded center is expected to integrate specialized expertise and coordinated operations across the full virome research pipeline at scale.

What kinds of capabilities are centers expected to have?

Based on the announcement, centers are expected to be able to: recruit and retain diverse cohorts; collect many types of biospecimens; isolate and detect viruses in multiple biological states (including circulating viruses as well as proviral and integrated forms); and generate standardized, high-quality datasets that can be compared across centers and over time.

Does the program focus only on finding viral sequences?

No. The intent is not just to identify viral sequences, but to produce rigorous characterization supported by strong methods, consistent protocols, robust analysis approaches, and datasets suitable for cross-site comparisons.

What does "deeply characterize" imply in this opportunity?

In this program, deep characterization refers to moving beyond detection to produce rigorous, high-quality characterization using consistent methods and protocols, including the ability to identify viruses in multiple biological states and generate standardized data for comparisons across centers and over time.

What kinds of viral states does the program mention?

The announcement explicitly notes that centers should be able to isolate and detect viruses in multiple biological states, including circulating viruses as well as proviral and integrated forms.

What expectations are stated about data quality and standardization?

The program emphasizes generating standardized, high-quality datasets that can be compared across centers and over time. This implies coordinated methods, consistent protocols, and robust analytic approaches to support reliable cross-site and longitudinal comparisons.

Will awardees be expected to share data and align practices across a consortium?

Yes. Funded centers will participate in a larger consortium that includes separately funded investigative teams. Awardees will take part in joint governance and coordination activities and will help develop and follow shared consortium policies, practices, and standards, which is intended to enable harmonized methods and pooled analyses.

What is the role of ethics, social, and legal implications (ELSI) in this program?

The centers are expected to address ELSI issues associated with human virome research. The announcement points to concerns such as privacy risks, returning results, incidental findings, stigma, and community concerns, especially when working with diverse populations and sensitive health contexts. The expectation is for well-developed approaches for responsible data practices, participant protections, and community-aware research conduct aligned with NIH expectations.

Why does the announcement emphasize ELSI for virome research?

The announcement notes that virome data can intersect with practical and sensitive issues, including privacy risks and questions about returning results or incidental findings, and may raise stigma or community concerns. These considerations are particularly important in longitudinal studies with diverse participants.

Is this funding opportunity intended to support clinical trials?

No. The title specifies "Clinical Trial Not Allowed." While the program involves human participants, longitudinal follow-up, and biospecimen collection for observational characterization work, it is not intended to support clinical trials as defined by NIH.

If clinical trials are not allowed, can the work still involve human participants?

Yes. The announcement describes studying people over time, recruiting and retaining cohorts, and collecting biospecimens across multiple body sites and tissues. The key constraint stated is that clinical trials (as defined by NIH) are not allowed under this opportunity.

Who is eligible to apply?

Eligibility is broad and includes many organization types such as 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 other entities listed in the announcement.

Are specific institution types explicitly highlighted as eligible?

Yes. The RFA explicitly calls out additional eligible applicant categories including 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.

Are non-U.S. organizations eligible to apply as the main applicant?

No. The announcement 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 as the prime applicant.

Are any international elements allowed in a project?

Yes. "Foreign components" (as defined by the NIH Grants Policy Statement) are allowed. This typically means a U.S.-based applicant may include certain well-justified international elements under NIH rules, even though the prime applicant must be domestic.

What is the Assistance Listing (CFDA) number for this opportunity?

The Assistance Listing (CFDA) number provided is 93.310.

What NIH category is this opportunity listed under?

The opportunity falls under the NIH funding activity category of Health and uses a cooperative agreement funding instrument.

What are the important dates listed in the posting?

The posting lists a creation date of September 13, 2023, and an original closing date of November 17, 2023.

How will applications be reviewed given the interdisciplinary scope?

The announcement notes that there are not existing standing study sections with the breadth of expertise needed to evaluate applications of this type. This indicates NIH expects review to be organized specifically to match the interdisciplinary scope, spanning areas such as virology, genomics, bioinformatics, clinical sampling, cohort operations, data standards, and ELSI.

What makes these centers different from typical single-project grants?

The announcement describes them as large, multicomponent centers with a required multicore structure, designed to run coordinated cohort-based virome science end to end. They are also expected to operate within a consortium model with shared standards and coordination, which is more complex and collaborative than many single-project grants.

What is the consortium model described in the opportunity?

Funded centers will collaborate as part of a larger consortium that includes separately funded investigative teams. Centers will not only produce their own outputs but will also participate in joint governance and coordination activities and help establish and follow shared consortium policies and standards.

What is the overall intended impact of the program?

The program aims to build shared infrastructure, standards, and knowledge to define what "normal" and "variable" looks like in the human virome across populations, body sites, and time, and to create program-wide resources that other researchers can build on.

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