Continuation of the Childhood Liver Disease Research Network (ChiLDReN) Clinical Centers (U01 Clinical Trial Required) | RFA DK 23 017

Opportunity Information: Apply for RFA DK 23 017

The National Institutes of Health (NIH) is offering a cooperative agreement opportunity to continue the work of the Childhood Liver Disease Research Network (ChiLDReN) through its Clinical Centers. This funding opportunity announcement, titled "Continuation of the Childhood Liver Disease Research Network (ChiLDReN) Clinical Centers (U01 Clinical Trial Required)," is listed as RFA DK 23 017. It falls under the discretionary funding category and uses a U01 cooperative agreement mechanism, which generally means awardees will carry out the research while working closely with NIH staff under a substantial programmatic involvement model. The announcement is tied to CFDA number 93.847 and is categorized under food and nutrition and health, reflecting its focus on clinical and translational research that can ultimately improve diagnosis, treatment, and outcomes for children with serious liver diseases.

The central purpose of the award is to maintain and advance ChiLDReN as a coordinated national (and potentially international) research network focused on rare pediatric liver diseases. The network structure includes a Scientific and Data Coordinating Center (SDCC) and multiple Clinical Centers (CC). In practical terms, the Clinical Centers are the sites where patients are identified and enrolled, clinical phenotyping and biospecimen collection occur, and prospective studies and clinical trials are implemented. The SDCC typically supports the backbone functions needed to run multi-site research efficiently and consistently, including data management, protocol coordination, quality control, regulatory support, and network-wide analytics. By continuing this established infrastructure, the FOA aims to support rigorous multi-center studies that would be difficult for any single institution to perform alone, especially given the rarity and clinical complexity of these conditions.

ChiLDReN's research scope is focused on a defined set of rare pediatric liver diseases and related disorders, including biliary atresia, Alagille syndrome, alpha-1-antitrypsin deficiency, progressive familial intrahepatic cholestasis (PFIC) syndromes, bile acid synthesis defects, mitochondrial hepatopathies, idiopathic neonatal hepatitis, cystic fibrosis liver disease, and primary sclerosing cholangitis. These conditions often involve early-life onset, variable progression, and significant risks of chronic liver failure, transplantation, and long-term complications. A core rationale for a dedicated network is to enable sufficiently powered observational studies and interventional trials, develop and validate biomarkers, refine clinical endpoints, and standardize diagnostic and management approaches across sites. Because many of these disorders are genetically driven or have distinct molecular mechanisms, the FOA's emphasis on translational research also signals interest in linking clinical outcomes with mechanistic insights, including genotype-phenotype relationships and biomarker development that can guide precision medicine approaches.

A key feature of the opportunity is that it is designated "Clinical Trial Required," indicating that applicants are expected to be prepared to participate in, and potentially lead, clinical trials as part of the network's research agenda. Within the cooperative agreement framework, Clinical Centers typically need demonstrated capabilities in pediatric hepatology and gastroenterology care, recruitment and retention of rare-disease populations, clinical research operations, and compliance with human subjects protections and trial oversight expectations. This can include experience with multi-site protocols, data and safety monitoring processes, regulatory submissions, standardized outcome assessments, and the operational capacity to collect and ship biospecimens, perform protocol-defined imaging or laboratory measures, and follow participants longitudinally. The broader aim is not only to conduct studies, but to do so in a coordinated way that produces high-quality, comparable data across all participating sites.

Eligibility for this FOA is broad and includes many types of U.S. public and private organizations. Eligible applicants listed include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities. The announcement also explicitly highlights additional eligible applicant categories that can be especially relevant for expanding research participation and reach, including 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, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities or foreign organizations. This inclusive eligibility language supports the possibility of broader geographic coverage, improved representation of underserved populations, and stronger community engagement in pediatric rare disease research, where disparities in diagnosis timing, access to specialty care, and transplant services can affect outcomes.

Important administrative details from the source listing include an original closing date of November 8, 2023, and a creation date of September 7, 2023. The award ceiling and expected number of awards were not specified in the provided listing, which typically means applicants would need to consult the full FOA text for budget limits, project period expectations, and the anticipated number of funded Clinical Centers. Overall, this opportunity is designed to sustain a mature, collaborative clinical research network that can generate actionable evidence for rare pediatric liver diseases, accelerate translation of discoveries into clinical practice, and support well-designed clinical trials that would be challenging to run outside a coordinated multi-center infrastructure.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Continuation of the Childhood Liver Disease Research Network (ChiLDReN) Clinical Centers (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2023-09-07.
• Applicants must submit their applications by 2023-11-08. (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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