ARDS, Pneumonia, and Sepsis Phenotyping Consortium Clinical Centers (U01 Clinical Trial Not Allowed) | RFA HL 23 001

Opportunity Information: Apply for RFA HL 23 001

The ARDS, Pneumonia, and Sepsis Phenotyping Consortium Clinical Centers funding opportunity (RFA HL 23 001) is a National Institutes of Health (NIH) cooperative agreement using the U01 mechanism, focused on building a clearer, more precise picture of why critically ill adults follow different disease paths and experience different recovery patterns. The central goal is to understand heterogeneity in three major, overlapping critical illness syndromes: acute respiratory distress syndrome (ARDS), community-acquired pneumonia, and sepsis. Rather than treating these conditions as single, uniform diagnoses, the initiative is aimed at identifying distinct phenotypes and the biological and clinical mechanisms that drive them, with the longer-term intent of improving how patients are classified, studied, and ultimately managed.

The research approach emphasized by this opportunity is a longitudinal observational study, meaning participants are followed over time without assigning experimental interventions. Clinical centers supported under this program are expected to enroll hospitalized adults with ARDS, community-acquired pneumonia, or sepsis and to track them from the time of hospitalization through recovery, continuing follow-up out to 1 year. A key feature is the use of common (harmonized) data elements and standardized biospecimen collection across sites, so that information and samples can be combined and compared reliably. This kind of shared infrastructure is designed to support high-quality phenotyping across diverse patient populations and care settings, enabling analyses that can connect bedside clinical trajectories with underlying biology.

Because this is a cooperative agreement (U01), awardees typically work in close partnership with NIH program staff, with substantial NIH involvement in coordination, governance, and major scientific decisions. In practice, that usually means there are consortium-wide expectations around adopting shared protocols, meeting enrollment and follow-up benchmarks, contributing data and specimens according to agreed standards, and participating in cross-site collaboration to ensure the overall study produces integrated, comparable datasets.

The announcement is explicitly labeled "Clinical Trial Not Allowed," which signals that the supported activities should not include prospective assignment of participants to interventions to evaluate health outcomes. The work is intended to be observational and focused on characterization, mechanism, and recovery patterns rather than testing a treatment or preventive strategy. Applicants proposing interventional clinical trial designs would not align with the stated scope.

Eligibility for this opportunity is broad and includes a wide range of domestic U.S. organizations and government entities. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized); Native American tribal organizations that are not federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations 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 opportunity also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal government agencies, and U.S. territories or possessions.

At the same time, there are important limits related to non-U.S. applicants and components. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization. In addition, non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, which generally means a U.S. applicant may include certain well-justified international elements or collaborations under NIH rules, even though a foreign institution cannot serve as the primary applicant.

From an administrative standpoint, the opportunity is categorized as discretionary funding and falls under the health funding activity category. The CFDA numbers listed (93.837, 93.838, 93.839, 93.859) indicate the NIH program areas tied to heart, lung, blood, and related research portfolios. The original closing date shown is 2022-06-17, and the posting creation date is 2022-01-21. Specific award ceiling and expected award counts are not provided in the source details you included, so prospective applicants typically would need to consult the full funding announcement and any linked NIH documentation for budget guidance, consortium structure, data sharing expectations, and the operational requirements placed on clinical center sites.

Overall, the grant is best understood as support for clinical centers that can recruit and longitudinally follow hospitalized adults with ARDS, community-acquired pneumonia, or sepsis, collect standardized clinical data and biospecimens over time, and contribute those materials to a coordinated consortium effort aimed at defining meaningful clinical and biological subgroups and understanding the mechanisms that shape both acute illness and long-term recovery.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "ARDS, Pneumonia, and Sepsis Phenotyping Consortium Clinical Centers (U01 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): 93.837, 93.838, 93.839, 93.859.
• This funding opportunity was created on 2022-01-21.
• Applicants must submit their applications by 2022-06-17. (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 HL 23 001

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