Ancillary Studies to Major Ongoing NIDDK and NHLBI Clinical Research Studies (R01) | Apply Online

Opportunity Summary:

The grant opportunity titled "Ancillary Studies to Major Ongoing NIDDK and NHLBI Clinical Research Studies (R01)" (Funding Opportunity Number PAR-07-024) is an NIH funding announcement designed to support new, add-on research projects that piggyback on large clinical studies that are already underway. The central idea is to let investigators ask additional, well-justified scientific questions by leveraging the infrastructure, participants, data systems, and follow-up procedures of existing major clinical research efforts. Rather than starting an entirely new clinical trial or cohort from scratch, applicants propose an "ancillary study" that attaches to a parent study, making the research faster and often more cost-efficient while still producing meaningful new findings.

The program is jointly tied to two NIH institutes: the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Heart, Lung, and Blood Institute (NHLBI). The specific objective is cross-institute enrichment: it aims to bring NIDDK-oriented ancillary research into either NIDDK-funded or NHLBI-funded parent studies, and likewise to bring NHLBI-oriented ancillary research into NIDDK-funded parent studies. In practical terms, that means a researcher might add diabetes, kidney, digestive, nutrition, or metabolic-focused measures to an ongoing heart or lung study, or add cardiovascular, pulmonary, or blood-related measures to an ongoing NIDDK-supported study. The parent studies can include large clinical trials, epidemiological studies, and disease databases, so the announcement is not limited to one particular study design as long as the parent resource is a major ongoing clinical research activity supported by NIDDK or NHLBI.

Funding is provided through the NIH Research Project Grant mechanism (R01). That signals a standard investigator-initiated research award structure, with peer review and the expectation of a strong scientific rationale, feasibility, and a clear plan for executing the ancillary work within the constraints of the parent study. The announcement does not set a single fixed budget cap or project length because it anticipates that ancillary studies can range widely in complexity, from relatively modest additions (for example, adding a targeted biomarker panel, specialized imaging, additional questionnaires, or an outcomes adjudication component) to more substantial embedded projects (for example, collecting and analyzing new biospecimens, adding mechanistic substudies, or implementing new follow-up assessments). As a result, the size and duration of awards vary by proposal, and the total number of awards depends on the volume of applications received and, most importantly, their quality, scientific merit, and cost.

The opportunity is categorized as a discretionary grant program under NIH, with activity areas connected to cardiovascular diseases research (CFDA 93.837) and diabetes, digestive, and kidney diseases extramural research (CFDA 93.847). There is no cost-sharing or matching requirement, which means applicants are not required to commit non-federal matching funds as a condition of eligibility. Application due dates are described as multiple receipt dates, indicating that submissions were accepted on scheduled cycles rather than a single one-time deadline, with applicants directed to the full announcement for the specific timing details that applied while the FOA was active.

Eligibility is broad and includes many types of organizations. Public and private institutions of higher education can apply, as can nonprofits (including those with and without 501(c)(3) status), state and local governments (including counties, cities/townships, special districts, and independent school districts), Native American tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, small businesses, and for-profit organizations other than small businesses. The eligibility language also specifies that foreign institutions are eligible to apply, that eligible federal agencies may apply, and that faith-based or community-based organizations may apply. This wide eligibility aligns with NIH norms for R01 opportunities, where the emphasis is typically on scientific capability, access to the parent study resource, and the ability to carry out the proposed work.

Overall, the FOA is aimed at maximizing the scientific return on existing large NIH-funded clinical research investments by encouraging creative, scientifically rigorous add-on studies that can be integrated into ongoing NIDDK and NHLBI parent projects. Applicants would generally need to demonstrate that the ancillary study is well aligned with the mission interests of the relevant institute, that it can be executed without compromising the integrity or primary aims of the parent study, and that the parent study infrastructure and leadership are able to accommodate the additional procedures, data collection, and analysis plans. For full operational details, the original announcement is linked through NIH at http://grants.nih.gov/grants/guide/pa-files/PAR-07-024.html, and NIH Office of Extramural Research support contacts are provided for access or technical linking issues.

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