Pilot and Feasibility Clinical and Translational Research Studies in Digestive Diseases and Nutrition (R21 Clinical Trial Optional) | PA 18 903

Opportunity Information: Apply for PA 18 903

The NIH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), through its Division of Digestive Diseases and Nutrition, offered this R21 funding opportunity (PA-18-903) to support early-stage, pilot, and feasibility clinical and clinical-translational research projects focused on digestive diseases and nutrition. The main goal is to help investigators generate the practical evidence needed to move a concept toward a later, larger, well-powered clinical study, or to push forward exploratory clinical-translational ideas that rely on human subjects. In other words, the program is meant to de-risk promising concepts by testing whether the study can actually be carried out as planned (and to uncover what would need to be fixed before scaling up), while also encouraging novel clinical-translational directions that are not yet ready for a full-scale trial.

On the clinical side, the announcement emphasizes pilot and feasibility work that directly examines operational or protocol challenges that could prevent successful completion of a future larger clinical study. Projects are expected to focus on issues like recruitment and retention, adherence, workflow, intervention delivery, data collection procedures, site readiness, and other real-world implementation barriers that often make or break larger trials. Rather than funding a definitive efficacy study, this mechanism is geared toward improving the chances that a subsequent, larger clinical study can be completed successfully by using smaller-scale human research to refine methods, confirm logistics, and validate that the proposed approach is workable.

On the clinical-translational side, the FOA is intended to promote exploratory and novel science through the use of human subjects. The emphasis is on translational concepts that can be examined in people, consistent with the program's intent to advance human-focused discovery in digestive diseases and nutrition. A key limitation is that translational studies relying on animal models are not supported under this announcement, reinforcing that this opportunity is specifically oriented toward research conducted in humans rather than preclinical animal experimentation.

The FOA also clearly identifies areas it will not support. Any proposal that includes obesity as a component of the study is out of scope for this funding opportunity, and applicants are directed instead to search for obesity-related opportunities through the NIH Office of Extramural Research funding listings. Additionally, as noted above, translational studies using animal models are excluded, keeping the portfolio centered on human subjects research.

This is an NIH discretionary grant opportunity using the R21 mechanism and is designated "Clinical Trial Optional," meaning applicants may propose studies that include a clinical trial if appropriate, but a trial is not required. The listing associates the program with CFDA 93.847 and the broad activity areas of health and food/nutrition. The maximum award amount stated is $200,000 (award ceiling), reflecting the smaller, exploratory nature of R21 projects.

Eligibility is broad across U.S.-based organizations and government entities, including state, county, city/township, and special district governments; independent school districts; public and state-controlled higher education institutions; private higher education institutions; federally recognized tribal governments; tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (outside higher education); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible applicant types 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), as well as faith-based/community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Foreign participation is explicitly restricted. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined in the NIH Grants Policy Statement are not allowed. Practically, that means the applicant organization and the work supported by the grant must remain within allowable domestic boundaries as described by NIH policy.

Key administrative details from the source record include an original closing date of September 7, 2020, and an initial creation date of August 14, 2018. Overall, the opportunity is best understood as a targeted R21 mechanism for human-focused digestive diseases and nutrition research, designed either to solve feasibility and operational challenges ahead of a larger clinical study or to explore new clinical-translational ideas in people, while excluding obesity-related projects and animal-model translational work.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Pilot and Feasibility Clinical and Translational Research Studies in Digestive Diseases and Nutrition (R21 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 2018-08-14.
• Applicants must submit their applications by 2020-09-07. (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 $200,000.00 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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