Lung Transplant Consortium - Data Coordinating Center (U24 - Clinical Trial Not Allowed) | RFA HL 22 003

Opportunity Information: Apply for RFA HL 22 003

The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), offered this cooperative agreement (U24) funding opportunity to establish and run the Data Coordinating Center (DCC) for the Lung Transplant Consortium (LTC). The overall purpose is to create a strong, centralized coordinating hub that can manage the complex day-to-day scientific and operational needs of a large, multi-site research consortium focused on lung transplantation. Importantly, the award is explicitly "Clinical Trial Not Allowed," meaning the DCC is expected to support observational clinical research rather than interventional trials.

At its core, the DCC is designed to be the engine that keeps multiple consortium studies running smoothly and consistently across sites. The LTC is expected to include roughly 24 Clinical Centers conducting observational studies that examine real-world lung transplant processes and outcomes. Two major scientific priorities are highlighted: understanding what influences donor lung utilization (why some donated lungs are used or not used for transplant) and identifying factors tied to acute lung allograft dysfunction in recipients (early injury or dysfunction of the transplanted lung). Because these questions require consistent data capture, standardized definitions, careful biospecimen handling, and coordinated analyses, the DCC serves as the central organization that sets up and maintains those shared systems.

The responsibilities of the DCC cover the full research lifecycle for consortium-wide observational studies. On the regulatory and administrative side, the DCC is expected to support compliance and coordination activities that typically include helping align multi-site documentation, tracking study progress, facilitating meetings, and keeping consortium operations organized and audit-ready. On the scientific operations side, the DCC oversees data collection and management, which generally means building and maintaining study databases, developing common data elements and case report forms, implementing data quality controls, supporting secure data transfer, and ensuring the integrity and completeness of the information coming from each participating Clinical Center. In parallel, the DCC coordinates biospecimen-related work, including guidance and infrastructure for collection, processing, labeling, shipping, storage, and chain-of-custody practices so that samples are usable and comparable across centers and over time.

A major deliverable for the DCC is statistical leadership and timely reporting. The FOA emphasizes statistical analyses and the reporting of results in a timely manner, which typically requires the DCC to provide statistical expertise for study design, analytic plans, interim descriptive reporting, final analyses, and contribution to manuscripts and presentations. The expectation is not only that the DCC can analyze data, but that it can do so in a way that supports multiple studies at once, maintains consistent methods, and helps the consortium translate findings into publications and other products efficiently. The DCC is also expected to help create sharable datasets and support secondary analyses by the broader research community, which implies strong attention to documentation, data dictionaries, de-identification practices, and policies or workflows that enable responsible data sharing.

Because this is a cooperative agreement, the relationship with NHLBI is intended to be collaborative and hands-on compared with a standard research grant. In practical terms, that usually means the DCC will work closely with NHLBI and the LTC Clinical Centers on protocol development, analytic strategy, and consortium priorities, while still being responsible for executing the coordinating functions at a high standard. The FOA also notes that this DCC opportunity runs in parallel with a separate FOA for the LTC Clinical Centers (RFA-HL-22-002), underscoring that the DCC and the centers are meant to be selected and then operate as integrated parts of the same consortium structure.

Another prominent element is communication, collaboration, and outreach. The DCC is expected to promote collaboration among LTC investigators and connect with the broader lung transplant research community. This includes coordinating outreach efforts and engaging external stakeholders such as foundations, professional societies, and other organizations with aligned interests in lung transplantation. The intent is to make the consortium more than a collection of independent studies by building shared momentum, standardizing practices, broadening participation, and ensuring that results and resources (like curated datasets) reach researchers who can extend the impact through secondary projects.

In terms of eligibility, the opportunity is broadly open to a wide range of U.S.-based organizations, including state and local governments, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, as well as certain tribal entities and housing authorities. The FOA also explicitly highlights eligibility for several mission-relevant institution types and community-based entities, such as 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 and eligible federal agencies. At the same time, it restricts 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 NIH policy are allowed, meaning a U.S. applicant may be able to include certain foreign activities or collaborations if they meet NIH requirements and are well-justified.

Finally, the basic administrative identifiers in the source information frame the opportunity: the FOA number is RFA-HL-22-003, the funding instrument is a cooperative agreement (U24), the agency is NIH, and the original closing date listed is June 15, 2021. The program falls under a health-related assistance listing (CFDA/Assistance Listing number 93.838). Overall, the opportunity is best understood as funding for an experienced coordinating center that can unify data, biospecimens, analytics, reporting, and stakeholder engagement across a large observational lung transplant research network, with the goal of generating high-quality, shareable evidence about donor lung use and early post-transplant lung dysfunction.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Lung Transplant Consortium - Data Coordinating Center (U24 - 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.)
• 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 22 003

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