Early Liver Transplantation Cohort Study for Alcohol-associated Liver Diseases (Collaborative R01 Clinical Trial Not Allowed) | RFA AA 22 003

Opportunity Information: Apply for RFA AA 22 003

The National Institutes of Health (NIH) funding opportunity titled "Early Liver Transplantation Cohort Study for Alcohol-associated Liver Diseases (Collaborative R01 Clinical Trial Not Allowed)" (Funding Opportunity Number: RFA-AA-22-003; CFDA: 93.273) supports observational, collaborative research on early liver transplantation (ELT) for adults with alcohol-associated liver disease (ALD). The core purpose is to fund multidisciplinary teams that can study, in real-world clinical settings, how patients are selected for ELT, how they are managed before and after transplant, and what outcomes they experience over time. The emphasis is on building longitudinal cohort studies that follow adult ALD patients who are being considered for early liver transplantation, with enough follow-up to meaningfully evaluate long-term outcomes related to ELT.

The research focus is explicitly observational rather than interventional. In practical terms, projects funded under this announcement are meant to collect and analyze clinical, psychosocial, and health-system data that reflect how ELT decisions are made and how those decisions play out over the long term, without assigning participants to experimental treatments or testing a transplant-related intervention as a clinical trial. The announcement’s framing highlights key domains of interest: factors that influence candidate selection (for example, clinical severity, comorbidities, psychosocial evaluations, addiction history and treatment engagement, center-specific policies, and equity considerations), management strategies (such as medical optimization, addiction medicine integration, mental health services, and post-transplant monitoring and support), and outcomes (including survival, graft outcomes, relapse patterns and substance use trajectories, adherence, quality of life, healthcare utilization, and other patient-centered and system-level endpoints). Because patients are followed longitudinally, the intent is to move beyond short-term transplant metrics and capture longer-run outcomes that matter for patients, transplant programs, and policymakers.

Structurally, this opportunity uses the NIH R01 grant mechanism and is categorized as a discretionary grant in the health funding activity area. The title specifies "Collaborative R01," signaling that the program expects coordination across investigators and disciplines, and potentially across sites, to assemble cohorts large and diverse enough to answer questions that single-center studies often cannot. The award ceiling listed in the provided source data is $350,000 (as stated), and the original closing date was 2022-09-30, indicating the application window for that specific announcement cycle.

A wide range of domestic U.S. applicants were eligible. Eligible applicant types included various levels of government (state, county, city or township, and special district governments), federally recognized Native American tribal governments, public and state-controlled institutions of higher education, private institutions of higher education, independent school districts, public housing authorities/Indian housing authorities, nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education where specified), for-profit organizations other than small businesses, small businesses, and other eligible entities. The announcement also explicitly called out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. At the same time, the eligibility rules were clear about foreign involvement: non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations were not eligible to apply, and foreign components (as defined by NIH policy) were not allowed under this FOA.

Overall, this grant opportunity was designed to strengthen the evidence base around early liver transplantation for alcohol-associated liver disease by supporting carefully designed, long-term cohort studies. The NIH’s intent, as reflected in the announcement language, is to generate actionable knowledge about who receives ELT, how care is delivered, and which clinical, behavioral, and system factors are linked to outcomes over time, using collaborative, multidisciplinary observational research rather than a clinical trial framework.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Early Liver Transplantation Cohort Study for Alcohol-associated Liver Diseases (Collaborative R01 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): 93.273.
• This funding opportunity was created on 2022-07-21.
• Applicants must submit their applications by 2022-09-30. (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 $350,000.00 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 AA 22 003

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