Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition (R21) | Apply Online

Frequently Asked Questions (FAQs)

What is the "Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition (R21)" opportunity?

It is an NIH grant opportunity that supports early-stage, exploratory clinical and epidemiological research focused on digestive and liver diseases, as well as nutrition-related disorders that occur in connection with digestive and liver conditions. The intent is to fund smaller pilot and feasibility projects that test new ideas, produce initial human data, and help determine whether a larger, definitive clinical study is justified and feasible.

Which NIH components are associated with this opportunity?

The opportunity is issued primarily through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), with participation from the National Cancer Institute (NCI) and the NIH Office of Dietary Supplements (ODS).

What is the main purpose of using the R21 mechanism for this program?

The NIH R21 activity code is intended for exploratory and developmental research. In this program, it is used to encourage limited-scope, preliminary projects that can generate early evidence (such as feasibility, acceptability, recruitment performance, or preliminary outcome signals) before investigators pursue a larger study.

Is this opportunity meant for large-scale clinical trials?

No. It specifically targets pilot and feasibility work rather than large-scale clinical trials. It is designed to support smaller, preliminary studies that help refine concepts and determine whether a larger trial or definitive study should move forward.

What kinds of projects are a good fit for this program?

Projects that fit well include early-stage clinical or clinically oriented epidemiological studies related to digestive and liver diseases and associated nutrition issues. Examples of the kinds of aims described include proving concept, refining protocols, developing recruitment and retention strategies, evaluating acceptability and adherence, testing measurement methods, estimating effect sizes, and collecting preliminary safety or outcome signals that would support a later, larger application.

What research areas are emphasized?

The opportunity emphasizes human-focused research aimed at treatment, prevention, and health promotion in populations affected by digestive and liver diseases. It also includes epidemiological research when it is clearly oriented toward clinical translation or toward understanding prevention and health promotion strategies.

Does the program support studies involving nutrition and dietary supplements?

Yes. The program includes nutrition-related disorders connected with digestive and liver conditions, and the NIH Office of Dietary Supplements (ODS) is a participating office. Proposals involving dietary supplements may be particularly relevant when they address scientifically grounded questions tied to prevention, symptom management, mechanisms in humans, or clinical outcomes in digestive and liver disease settings.

What is the funding instrument and award type?

The funding instrument is a discretionary grant using the NIH R21 activity code.

What is the award ceiling for this opportunity?

The listed award ceiling is $200,000, reflecting the focus on limited, early-stage projects rather than extensive, multi-year efforts.

Is cost sharing or matching required?

No. There is no cost sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of receiving an award.

Which federal assistance listings (CFDA) are associated with the program?

The opportunity is associated with CFDA 93.393 (cancer cause and prevention research) and CFDA 93.847 (diabetes, digestive, and kidney diseases extramural research). This signals that relevant proposals may cross disease areas where digestive, liver, nutrition, and cancer prevention priorities overlap.

Who is eligible to apply?

Eligibility is broad and includes many organization types capable of clinical or population-based research. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain nonprofits without 501(c)(3)), for-profit organizations (including small businesses and other for-profits), and governmental entities such as state, county, city or township governments, special district governments, and independent school districts.

Are tribal organizations and tribal governments eligible?

Yes. Tribal organizations and tribal governments are explicitly included among eligible applicants.

Are public housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are included in the eligibility list.

Are community-serving and mission-driven institutions eligible?

Yes. The eligibility list highlights that institutions 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 faith-based or community-based organizations are eligible.

Are U.S. territories and regional organizations eligible?

Yes. Regional organizations and U.S. territories or possessions are included among eligible applicants.

Can foreign institutions apply?

Yes. Non-U.S. entities (foreign institutions) are eligible to apply. In addition, non-U.S. components of U.S. organizations may participate, and foreign components are allowed consistent with NIH policy.

What types of studies does the opportunity describe as appropriate (clinical vs. epidemiological)?

The opportunity expects projects to be clinical or epidemiological in nature. That includes studies involving human participants, human-derived data, or population-level approaches, so long as the work is oriented toward clinical translation or toward prevention and health promotion strategies related to digestive and liver conditions.

What practical deliverables or outcomes are typical for an R21 pilot/feasibility project under this program?

Typical outcomes described include establishing whether recruitment and retention strategies work, evaluating acceptability and adherence, refining study protocols, testing measurement methods, estimating effect sizes, and collecting early safety and outcome signals that could justify a later, larger application (such as an R01 or a full-scale clinical trial).

Is this specific funding announcement currently active?

No. The record indicates it was posted March 23, 2012, with an original closing date of May 7, 2015, a current closing date of July 31, 2015, and an archive date of August 31, 2015. Those dates indicate this specific announcement is no longer active for new submissions under that opportunity number and timeline.

Where was the official announcement posted?

The official text and detailed requirements were provided through the NIH grants policy and guide system. The referenced NIH Guide page for the announcement is: http://grants.nih.gov/grants/guide/pa-files/PA-12-139.html

Who should be contacted for technical help accessing the announcement?

For technical help accessing the announcement, the notice directed applicants to the NIH Office of Extramural Research (OER) webmaster email listed in the notice.

How should applicants think about "fit" with this program based on the description?

Based on the provided description, the clearest fit is human-focused research aimed at digestive and liver disease treatment, prevention, or health promotion, including nutrition interventions or dietary supplement questions when they connect to digestive or liver disorders and are framed around clinically meaningful or preventive endpoints.