Mechanistic Studies of the Interaction between SARS-CoV-2/COVID-19 and Diseases and Organ Systems of Interest to NIDDK (R01 Clinical Trial Optional) | RFA DK 20 021

Opportunity Information: Apply for RFA DK 20 021

The NIH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) funding opportunity RFA-DK-20-021, titled "Mechanistic Studies of the Interaction between SARS-CoV-2/COVID-19 and Diseases and Organ Systems of Interest to NIDDK (R01 Clinical Trial Optional)," supports research projects that dig into the biological and clinical mechanisms connecting COVID-19 with diseases and organ systems central to NIDDKs mission. The focus is not simply on describing outcomes or reporting associations, but on explaining how and why SARS-CoV-2 infection affects susceptibility, routes of infection, the clinical course of disease, and resulting morbidity and mortality, especially in people who already have underlying conditions. It also emphasizes investigating harmful acute or long-term effects of COVID-19 on specific organs, tissues, and physiological systems under NIDDK oversight.

The scientific scope is broad but clearly centered on NIDDK-relevant areas, including diabetes and other metabolic diseases, obesity, and disorders involving endocrine function. It also highlights the digestive system and related organs such as the liver and pancreas, along with kidney and urological systems and hematologic tissues and diseases. In practical terms, this means proposals could examine mechanisms such as viral entry and tropism in these tissues, immune and inflammatory pathways that worsen organ injury, metabolic or endocrine disruptions that change disease severity, or post-acute sequelae that persist after initial infection. Both basic mechanistic studies and clinical mechanistic research are within scope, and the announcement is explicitly "clinical trial optional," meaning applicants can propose projects with or without clinical trials depending on the scientific question and design.

This FOA uses the NIH R01 grant mechanism, which typically funds mature, hypothesis-driven projects with a defined set of aims. The listing characterizes the award with an award ceiling of $250,000 and identifies the activity category as health, food, and nutrition, with CFDA number 93.847. The original closing date provided is December 16, 2020, and the opportunity was created on July 10, 2020, reflecting its role as part of the early COVID-19 research response, particularly for conditions and organs known or suspected to influence COVID-19 outcomes.

Eligibility is expansive and includes many types of U.S.-based applicants: state, county, city or township governments; 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 that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education when specified in the categories); for-profit organizations other than small businesses; small businesses; and other organizations as allowed under NIH policy. The FOA also calls out additional eligible applicant categories commonly emphasized by NIH to encourage broad participation, including 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), as well as eligible federal agencies and faith-based or community-based organizations. U.S. territories or possessions and regional organizations are also included among eligible applicants.

At the same time, the FOA places clear limits on non-U.S. applications. Non-domestic (non-U.S.) entities (foreign organizations) and non-domestic (non-U.S.) foreign institutions are stated as not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined by the NIH Grants Policy Statement, meaning a U.S.-based applicant can include certain foreign elements (such as collaborations or specific performance sites) when justified and compliant with NIH policy, even though foreign organizations cannot serve as the primary applicant.

Overall, this opportunity is designed for research teams aiming to uncover the mechanistic links between SARS-CoV-2 infection and the onset, worsening, or long-term consequences of disease in NIDDK-relevant organ systems. Competitive projects under this FOA would be expected to move beyond descriptive epidemiology and instead generate actionable biological insight into pathways of vulnerability, tissue-specific injury, and recovery or chronic dysfunction affecting metabolic, endocrine, digestive, hepatic, pancreatic, renal, urologic, and hematologic health in the context of COVID-19.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Mechanistic Studies of the Interaction between SARS-CoV-2/COVID-19 and Diseases and Organ Systems of Interest to NIDDK (R01 Clinical Trial Optional)" 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 2020-07-10.
• Applicants must submit their applications by 2020-12-16. (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 $250,000.00 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.

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