ARDS, Pneumonia, and Sepsis Phenotyping Consortium Coordinating Center (U01 Clinical Trial Not Allowed) | RFA HL 23 002

Opportunity Information: Apply for RFA HL 23 002

The ARDS, Pneumonia, and Sepsis Phenotyping Consortium Coordinating Center (RFA-HL-23-002) is an NIH cooperative agreement (U01) funding opportunity aimed at establishing a central Coordinating Center to run and support a multi-site research effort known as the Acute Respiratory Distress Syndrome (ARDS), Pneumonia, and Sepsis Phenotyping Consortium (APS Consortium). The overall purpose is to improve understanding of why patients with these critical illness syndromes can look similar clinically yet have very different underlying biology, disease trajectories, and recovery patterns. By focusing on heterogeneity and shared or distinct mechanisms across ARDS, pneumonia, and sepsis, the consortium is designed to enable more precise classification (phenotyping) of patients and, ultimately, to inform future targeted therapies and better approaches to care.

The scientific work supported by the consortium is described as a prospective, longitudinal observational study, meaning participants are followed forward in time and data are collected without assigning experimental interventions. The study will enroll 5,000 hospitalized adults diagnosed with one or more of the following: ARDS, pneumonia, and/or sepsis. A key feature is the use of common, standardized data elements and harmonized biospecimen collection across all participating sites so that results can be compared and pooled reliably. In addition to in-hospital information, the design expects that about half of the participants who are discharged will complete follow-up assessments at 3, 6, and 12 months. These follow-ups are intended to capture long-term outcomes and recovery, including how biological signals and physiological impairments resolve or persist after acute illness, which is especially important given the lasting disabilities many survivors experience.

The Coordinating Center is the operational backbone of this effort. While the announcement emphasizes the overall consortium goals more than a task-by-task scope in the provided text, the intent of a Coordinating Center in a large NIH consortium is typically to provide centralized leadership for study coordination across multiple clinical sites. That usually includes managing or supporting protocol implementation and consistency, overseeing common data and biospecimen standards, coordinating communication and governance across sites, ensuring high-quality and timely data capture (including imaging data), and facilitating the logistics of longitudinal follow-up. Because this is a cooperative agreement, the NIH is expected to have substantial programmatic involvement, with the Coordinating Center working collaboratively with NIH staff and participating sites rather than operating fully independently.

A major deliverable highlighted in the opportunity is the creation of a broadly usable community resource. Throughout the funding period, the consortium will make collected data, including imaging data, and biospecimens available to the wider research community as rapidly and simply as possible. This positions the project not only as a single study, but also as an infrastructure and repository effort that can accelerate additional research beyond the original consortium investigators. In practice, this kind of resource-forward model often implies strong expectations for data stewardship, documentation, standardization, and clear access processes so that external researchers can reuse the materials effectively and responsibly.

Eligibility is broad and includes many types of domestic U.S. organizations and governmental entities, such as state, county, and city governments; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities. The announcement explicitly notes additional eligible applicant categories that NIH often calls out for emphasis, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

At the same time, the FOA draws clear boundaries around non-U.S. applicants. 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. This distinction generally means the applicant organization must be U.S.-based, but it may be permissible to include certain well-justified activities conducted outside the U.S. as part of the project if they meet NIH policy requirements and are appropriately described and approved.

Administratively, the opportunity is listed under NIH with a discretionary funding category and a health activity focus, and it references CFDA numbers 93.837, 93.838, 93.839, and 93.859. The original closing date shown is June 17, 2022, and the FOA creation date is January 21, 2022. The award ceiling and expected number of awards are not specified in the provided source text. The title also states "Clinical Trial Not Allowed," reinforcing that the proposed work for this Coordinating Center should not include an NIH-defined clinical trial, aligning with the observational nature of the consortium study.

Overall, this FOA is about building and operating the central hub for a large, standardized, multi-site observational cohort of critically ill adults with ARDS, pneumonia, and sepsis, with a strong emphasis on long-term follow-up and on producing a high-value, shareable dataset and biospecimen resource for the broader scientific community.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "ARDS, Pneumonia, and Sepsis Phenotyping Consortium Coordinating Center (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 23 002

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