Lung Transplant Consortium - Clinical Centers (U01 - Clinical Trial Not Allowed) | RFA HL 22 002

Opportunity Information: Apply for RFA HL 22 002

The Lung Transplant Consortium - Clinical Centers funding opportunity (RFA-HL-22-002) is a National Institutes of Health cooperative agreement (U01) meant to build a coordinated, multi-site consortium of high-volume lung transplant clinical centers. The central goal is to support observational and complementary mechanistic clinical research that explains how differences in real-world transplant decision-making and management across centers influence two big areas: how often donor lungs are used (donor lung utilization) and what happens to patients early after transplant. The FOA is explicitly not for clinical trials; instead, it is designed around systematically capturing clinical practice variation, outcomes, and biospecimens, then using those resources to answer hypothesis-driven questions.

A key scientific emphasis is on early post-transplant complications that remain major causes of illness and worse outcomes after lung transplantation, especially primary graft dysfunction (PGD) and acute lung allograft dysfunction (ALAD). Applicants are expected to focus on how site-specific selection criteria (for donors and/or recipients) and clinical management strategies (perioperative and early post-operative care, preservation approaches, immunosuppression practices, ventilation strategies, and other center-level protocols) may contribute to differences in donor lung acceptance and short-term outcomes. The program is built to compare and learn from these variations rather than impose a single practice model, with the idea that better evidence could ultimately guide more effective, safer, and more consistent transplant care.

To be competitive and eligible as a Clinical Center (CC), each application must be organized as a multidisciplinary effort and must include, at minimum, both a lung transplant surgeon and a lung transplant pulmonologist as part of the investigative leadership. The FOA also sets a scale requirement: the proposed CC structure must include a primary site plus any subsites that together perform at least 100 lung transplants annually. This volume threshold signals that the consortium is intended to generate robust, generalizable data quickly, and that participating sites must be able to reliably enroll participants and contribute meaningful numbers of cases and biospecimens.

From a project design standpoint, each CC application is expected to propose clear, hypothesis-driven research questions tied to donor and/or recipient practices and their relationship to outcomes like donor lung utilization, PGD, ALAD, or other relevant short-term endpoints. Importantly, the questions must be answerable using observational approaches and/or through biospecimen collection and analysis performed at the participating sites. In other words, the FOA is looking for rigorous clinical research that can leverage prospective and/or systematically collected clinical data, paired where appropriate with mechanistic measurements from blood, airway samples, tissue, or other biospecimens, without introducing interventional trial components.

Beyond each center’s local research aims, the consortium structure requires substantial coordination across all funded CCs. Awardees will be expected to enroll participants under a common research protocol and to contribute to a standardized core dataset and a core set of biospecimens that will be collected consistently across consortium sites. Oversight and harmonization will occur through a centralized Data Coordinating Center (DCC) and a Steering Committee (SC). This shared infrastructure is meant to produce a longitudinal resource that goes beyond any single center’s project, allowing investigators across the consortium to pursue additional high-value questions over time, including questions that may emerge only after enough standardized data and samples have been accumulated.

This FOA runs alongside a companion funding announcement for the Lung Transplant Consortium Data Coordinating Center (RFA-HL-22-003). Functionally, that means the Clinical Centers are not expected to independently build the full coordinating infrastructure; instead, they plug into a centrally managed system for data standards, participant tracking, quality control, biospecimen governance, and cross-site analyses, while still maintaining strong on-the-ground enrollment and sample collection capabilities.

In terms of who can apply, eligibility is broad and includes many standard U.S. organizational categories such as state and local governments, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, as well as federally recognized tribal governments and other tribal organizations. The FOA also highlights additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations), reflecting an intent to enable broad participation so long as the applicant can meet the clinical center and volume requirements.

Administratively, this is a discretionary funding opportunity using the cooperative agreement mechanism, which typically means NIH will have substantial programmatic involvement compared with a standard research grant. The CFDA number listed is 93.838 (heart, lung, and blood research). The opportunity’s original closing date is shown as 2021-06-15, and the listed award ceiling is $275,000. The announcement was created on 2021-02-25. Taken together, the FOA is essentially building a coordinated clinical research network where high-volume transplant centers contribute standardized data and biospecimens, enabling the field to more clearly identify which donor/recipient selection and early management practices lead to better utilization of scarce donor lungs and fewer early complications after lung transplantation.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Lung Transplant 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): 93.838.
• This funding opportunity was created on 2021-02-25.
• Applicants must submit their applications by 2021-06-15. (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 $275,000.00 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 HL 22 002

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