Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01) | Apply Online

Opportunity Summary:

The grant opportunity titled "Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01)" (Funding Opportunity Number PAR 09-247) is a National Institutes of Health discretionary grant designed to support add-on, or "ancillary," research projects that leverage the infrastructure, participants, specimens, and data already being collected in large, ongoing clinical research efforts. The central idea is to fund new, well-focused research questions that can be answered efficiently by building on an existing major study, rather than starting an entirely new trial or cohort from scratch. These ancillary projects are meant to produce additional scientific value from established clinical research platforms, especially when the proposed work can be integrated into ongoing operations such as follow-up visits, specimen collection schedules, or established data systems.

The FOA specifically targets ancillary studies connected to major clinical research studies, including clinical trials, epidemiologic studies, and disease databases. In this context, "major" studies include multi-center investigations, national databases, and Phase 3 clinical trials. The primary emphasis is on studies supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the announcement points investigators to an NIDDK webpage listing example eligible major studies. At the same time, the FOA is open to ancillary studies that plug into major clinical research studies supported by other NIH Institutes and Centers, other government agencies, or even private-sector efforts, as long as the ancillary project clearly advances the NIDDK mission. In practical terms, that means the science needs to align with NIDDK priority areas such as diabetes, digestive diseases, kidney and urologic diseases, obesity and nutrition-related research areas within its scope, and other NIDDK-supported scientific domains described on the institute's research webpage.

Funding is provided through the NIH Research Project Grant (R01) mechanism. That indicates the program expects a full, hypothesis-driven research plan with clear aims, strong scientific rationale, and a feasible approach, comparable to standard R01 expectations, but with added emphasis on how the work will integrate with the parent study and why the parent study is essential for the proposed aims. Because these are ancillary studies, successful applications typically need to demonstrate practical compatibility with the existing clinical study (for example, minimal disruption to ongoing trial operations, realistic additional burden on participants and sites, and a clear plan for accessing data/specimens). Although the provided summary text does not list detailed budget limits or project period caps, the R01 mechanism generally supports multi-year projects and substantial research activity when justified.

The opportunity is categorized under the "Food and Nutrition" and "Health" activity areas and is associated with CFDA number 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). It does not require cost sharing or matching, which reduces barriers for applicants who may not have institutional funds available to commit to the project. The sponsoring agency is the NIH.

Eligibility is broad and includes many common NIH applicant types: public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations (including small businesses and other for-profits), and a wide range of governmental entities (state, county, city/township, special district governments, and independent school districts). The eligibility language also explicitly includes various mission-driven and community-based organizations and institution 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, tribal governments and tribal organizations, U.S. territories and possessions, and faith-based or community-based organizations. Notably, the announcement also indicates that non-U.S. entities (foreign organizations) and regional organizations may be eligible, which can be important for ancillary work tied to international cohorts or global multicenter studies, assuming the project still fits the NIDDK mission and meets NIH policy requirements.

From an applicant's perspective, the key requirement embedded throughout the description is that the proposed ancillary study must be scientifically compelling and mission-relevant to NIDDK, and it must be anchored to an existing major clinical research study in a way that is both feasible and value-added. In other words, reviewers would be looking for a clear explanation of why the parent study provides a unique or cost-effective opportunity, what incremental procedures or analyses will be done, how the ancillary study will coordinate with the parent study leadership and operations, and what new knowledge will be generated that would not be achievable (or would be far less efficient) without leveraging that ongoing major study.

Administrative details included in the source data show the FOA was originally posted on August 11, 2009, with later record creation dated August 16, 2012. The listed original closing date was September 7, 2012, with a current closing date of August 17, 2012, and an archive date of September 17, 2012. The full announcement was made available through the NIH grants policy/guide page associated with PAR 09-247, and the contact provided for access or linking issues is the NIH Office of Extramural Research (OER) webmaster (FBOWebmaster@OD.NIH.GOV).

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