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.Apply for RFA HL 22 003
- 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.
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Frequently Asked Questions (FAQs)
What is this NIH/NHLBI funding opportunity?
This is an NIH funding opportunity from the National Heart, Lung, and Blood Institute (NHLBI) to support a cooperative agreement (U24) for a Data Coordinating Center (DCC) for the Lung Transplant Consortium (LTC). The FOA number is RFA-HL-22-003.
What is being funded under this award?
The award funds the establishment and operation of a centralized Data Coordinating Center that serves as the coordinating hub for the Lung Transplant Consortium. The DCC is expected to manage scientific and operational coordination across a large, multi-site observational research network focused on lung transplantation.
What is the main purpose of the Lung Transplant Consortium Data Coordinating Center (DCC)?
The DCC is intended to be the central engine for consortium-wide observational studies by standardizing and supporting day-to-day operations across sites, including data systems, biospecimen coordination, statistical analysis, reporting, and communication across the consortium.
Are clinical trials allowed under this opportunity?
No. The opportunity is explicitly designated as "Clinical Trial Not Allowed," which means the DCC is expected to support observational clinical research rather than interventional clinical trials.
How large is the Lung Transplant Consortium expected to be?
The consortium is expected to include roughly 24 Clinical Centers conducting observational studies related to lung transplantation processes and outcomes.
What scientific areas are emphasized for the consortium’s observational studies?
Two major scientific priorities are highlighted: (1) understanding factors that influence donor lung utilization (why donated lungs are used or not used for transplant), and (2) identifying factors associated with acute lung allograft dysfunction in recipients (early injury or dysfunction of the transplanted lung).
What types of activities does the DCC support across the research lifecycle?
The DCC responsibilities span the full lifecycle of consortium-wide observational studies, including regulatory and administrative coordination, data collection and data management, biospecimen coordination, statistical leadership, timely reporting, and support for producing shareable datasets and enabling secondary analyses.
What are the DCC’s expected regulatory and administrative coordination functions?
The DCC is expected to support compliance and coordination activities typical of multi-site research efforts, such as helping align multi-site documentation, tracking study progress, facilitating meetings, organizing consortium operations, and maintaining audit-ready processes.
What are the DCC’s expected data management responsibilities?
The DCC is expected to oversee data collection and management activities that generally include building and maintaining study databases, developing common data elements and case report forms, implementing data quality controls, supporting secure data transfer, and ensuring integrity and completeness of data submitted by participating Clinical Centers.
Why are standardized definitions and common data elements important for this consortium?
Because the consortium addresses multi-site observational questions (such as donor lung utilization and early allograft dysfunction), consistent data capture and standardized definitions are necessary so results can be reliably compared and combined across centers and over time.
What biospecimen-related responsibilities are expected of the DCC?
The DCC is expected to coordinate biospecimen-related work by providing guidance and infrastructure for collection, processing, labeling, shipping, storage, and chain-of-custody practices so that samples are usable and comparable across sites and time periods.
What does the FOA say about statistical analysis and reporting?
The FOA emphasizes statistical leadership, statistical analyses, and timely reporting of results. This typically includes statistical support for study design, analytic plans, interim descriptive reporting, final analyses, and contributions to manuscripts and presentations.
Does the DCC need to support more than one study at a time?
Yes. The DCC is expected to provide analytic and coordinating capabilities that can support multiple consortium studies simultaneously, while maintaining consistent methods and efficient production of consortium outputs.
What does “cooperative agreement (U24)” mean in this context?
As a cooperative agreement (U24), the relationship with NHLBI is intended to be more collaborative and hands-on than a standard research grant. The DCC is expected to work closely with NHLBI and LTC Clinical Centers on protocol development, analytic strategy, and consortium priorities, while executing core coordinating functions at a high standard.
How does this DCC FOA relate to the FOA for the Lung Transplant Consortium Clinical Centers?
This DCC opportunity runs in parallel with a separate FOA for the LTC Clinical Centers (RFA-HL-22-002). The intent is that the DCC and the Clinical Centers will be selected and then operate as integrated components of the same consortium.
Is data sharing expected under this award?
Yes. The DCC is expected to help create sharable datasets and support secondary analyses by the broader research community. This implies attention to documentation, data dictionaries, de-identification practices, and policies or workflows that enable responsible data sharing.
What kinds of deliverables are implied by “sharable datasets” and “secondary analyses” support?
Based on the described expectations, the DCC would typically produce well-documented datasets (including data dictionaries and supporting documentation) and implement processes that support de-identification and appropriate access for secondary analyses.
What communication and outreach activities are expected of the DCC?
The DCC is expected to promote collaboration among LTC investigators and connect with the broader lung transplant research community, including coordinating outreach and engaging external stakeholders such as foundations, professional societies, and other organizations with aligned interests in lung transplantation.
Why does the FOA emphasize collaboration and stakeholder engagement?
The described intent is to make the consortium more than a set of independent studies by building shared momentum, standardizing practices, broadening participation, and ensuring consortium results and resources (including curated datasets) reach researchers who can extend the impact through additional projects.
Who is eligible to apply?
Eligibility 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), small businesses, certain tribal entities, and housing authorities. The FOA also highlights eligibility for mission-relevant institution types and community-based entities (such as HBCUs, Hispanic-serving Institutions, TCCUs, Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, faith-based or community-based organizations, and eligible federal agencies).
Are non-U.S. (foreign) organizations eligible to apply directly?
No. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply.
Are foreign collaborations allowed in any form?
Foreign components (as defined by NIH policy) are allowed. This means a U.S. applicant may be able to include certain foreign activities or collaborations if they meet NIH requirements and are appropriately justified.
Which federal agency is offering this opportunity?
The opportunity is offered by the National Institutes of Health (NIH) through the National Heart, Lung, and Blood Institute (NHLBI).
What is the Assistance Listing (CFDA) number for this program?
The Assistance Listing (CFDA) number provided is 93.838.
What is the original closing date listed for this FOA?
The original closing date listed is June 15, 2021.
What is the best high-level description of the DCC’s role in the consortium?
The DCC is intended to unify and standardize data, biospecimens, analytics, reporting, and cross-site collaboration across a large observational lung transplant research network, enabling high-quality evidence generation and creation of resources that can be shared for broader scientific use.
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