Multi-Omics for Health and Disease - Disease Study Sites (U01 Clinical Trial Optional) | RFA HG 22 008

Opportunity Information: Apply for RFA HG 22 008

This NIH funding opportunity (RFA-HG-22-008) supports the creation of Disease Study Sites (DSS) under a U01 cooperative agreement, meaning awardees will carry out their projects in close collaboration with NIH and the broader program partners. The overall purpose is to push multi-omics approaches forward in real-world health and disease research, especially in diverse populations. Rather than focusing primarily on discovering brand-new causes of disease, the program is designed to test, validate, and improve generalizable ways of using multi-omics to detect meaningful biological changes tied to health, disease status, and changes over time.

The DSS awards are one part of a larger coordinated initiative that also includes Omics Production Centers (RFA-HG-22-009) and a Data Analysis and Coordination Center (RFA-HG-22-010). In practice, a DSS is expected to bring the clinical context: it proposes and runs a study in a specific disease area where integrated multi-omics is likely to be especially informative. The multi-omics data generated through the program is intended to be analyzed alongside rich phenotypic information and environmental exposure data, explicitly including social determinants of health (SDOH). This integrated approach is central to the FOA, since the goal is to connect molecular patterns with clinical and lived-environment factors in a way that can be compared and reused across diseases and study sites.

Across the consortium, the DSS program has three main objectives. First, it aims to explore how multi-omics, combined with phenotype and exposure/SDOH data, can be used to detect and characterize molecular profiles associated with healthy versus disease states. Second, it aims to develop broadly useful methods for data harmonization, integration, and analysis, along with best practices and standards that make multi-omics studies more consistent, comparable, and scientifically reliable across different settings. Third, it aims to produce a high-value, multi-dimensional dataset that will be made available to the wider research community, supporting downstream discovery and method development beyond the funded sites.

In terms of what a DSS is expected to do, each site is primarily responsible for designing a disease-focused study and then executing it in a way that supports consortium-wide learning. That includes putting strong participant enrollment and consent processes in place, collecting clinical/phenotypic data and environmental exposure measures (including SDOH variables), and collecting biological samples and other measures repeatedly over time when appropriate. Because this is a cooperative agreement within a consortium, DSS teams are also expected to contribute to shared protocol development, collaborative analysis, methods development, and the coordinated production and sharing of the final multi-dimensional dataset.

The FOA is labeled "Clinical Trial Optional," which signals that clinical trials are not required for all projects, but applicants can propose a trial component if it fits the scientific plan and meets NIH requirements. The activity sits within NIH program areas connected to education, environment, and health, and is associated with CFDA numbers 93.113, 93.172, 93.396, and 93.399. The awarding agency is the National Institutes of Health.

Eligibility is broad and includes many U.S.-based organizational types: state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other organizations. The FOA also explicitly highlights participation from organizations such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, faith-based and community-based organizations, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities (TCCUs), regional organizations, and U.S. territories or possessions, reflecting the program emphasis on diversity and inclusion in study populations.

Foreign eligibility is limited. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant organization may be able to include certain foreign activities or collaborations if they meet NIH policy requirements and are well-justified within the project scope.

Key administrative details provided include an original closing date of 2022-11-18, a listed award ceiling of $500,000, and an expected awards field that is not specified in the provided text. The opportunity was created on 2022-09-07. Overall, the opportunity is best understood as a consortium-based effort to standardize and strengthen how multi-omics is applied in disease-focused, longitudinal, and population-diverse settings, while producing reusable datasets, methods, and best practices for the broader scientific community.

• The National Institutes of Health in the education, environment, health sector is offering a public funding opportunity titled "Multi-Omics for Health and Disease - Disease Study Sites (U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.172, 93.396, 93.399.
• This funding opportunity was created on 2022-09-07.
• Applicants must submit their applications by 2022-11-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• 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 HG 22 008

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