Ancillary Studies of Kidney Disease Accessing Information from Clinical Trials, Epidemiological Studies, and Databases (R01) | Apply Online

Opportunity Summary:

The NIH, through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), offered this R01 grant opportunity to support investigator-initiated ancillary studies that leverage information from existing or ongoing research efforts to advance knowledge about kidney disease. The core idea is to build on the value of clinical trials, epidemiological studies, and large datasets that already exist by adding new questions, new measurements, or new analyses that were not part of the original project aims but can be addressed using the same participant cohorts, infrastructure, or stored data and specimens. In practical terms, this program is meant to help researchers get more scientific return from prior investments by reusing high-quality data sources, extending follow-up, or collecting additional kidney-relevant information in studies that are already underway.

The kinds of ancillary work encouraged under this announcement include both low-burden and more involved approaches. On the lower-burden end, applicants could propose new analyses of completed studies using existing datasets, including large public-access databases or other established repositories. On the more involved end, applicants could propose additional data collection or the collection of biological specimens in ongoing investigations, as long as the work is clearly positioned as an add-on to an existing clinical trial or epidemiological study rather than a completely standalone project. Importantly, the parent study does not have to be a kidney-only study; trials and cohort studies focused on other diseases or populations are also considered appropriate if they provide a meaningful opportunity to examine kidney outcomes, kidney risk factors, or kidney-related complications.

Scientifically, the announcement emphasizes research that improves understanding of (1) risk factors for developing kidney disease and the co-morbid conditions that often travel with it, (2) factors tied to faster loss of kidney function among people who already have chronic kidney disease (CKD), and (3) how kidney disease affects daily life, including quality of life and both mental and physical functioning. The description specifically calls out co-morbid illnesses such as malnutrition and cardiovascular disease as areas of interest, reflecting the real-world reality that kidney disease is often intertwined with broader metabolic and cardiovascular health. The announcement also highlights biomarker studies as an appropriate direction, including work focused on patients with acute renal failure (acute kidney injury) and other kidney diseases, suggesting an interest in tools that could improve risk prediction, early detection, disease phenotyping, or monitoring.

Another notable feature is that NIDDK explicitly encourages ancillary studies linked to both government-supported and non-government-supported trials and epidemiological studies. That widens the pool of possible “parent” studies and signals that the key requirement is the scientific opportunity and feasibility of meaningful kidney-related ancillary aims, not the funding source of the original project. In addition, the encouragement of analyses using large public-access databases indicates that proposals did not necessarily need access to a proprietary cohort, as long as the dataset is robust enough to answer important kidney-related questions.

Administratively, this was a discretionary NIH funding opportunity using the R01 research project grant mechanism, and it did not require cost sharing or matching. The eligible applicant list was broad, spanning state, local, and tribal governments; public and private institutions of higher education; nonprofit organizations (including those with and without 501(c)(3) status); small businesses and other for-profit organizations (with limits noted in the eligibility text); public housing authorities; school districts; and other special district governments. Eligibility also extended to foreign institutions, eligible federal agencies, and faith-based or community-based organizations, which is relatively inclusive compared with some NIH announcements and suggests the program was open to diverse institutional settings capable of conducting rigorous ancillary research.

Key dates in the source information show that the opportunity was posted on November 21, 2006 (PA-07-050), with multiple receipt dates and a final listed closing date of September 7, 2009, followed by an archive date of October 8, 2009. The full announcement was hosted through the NIH grants guide, and general technical assistance for accessing the announcement was directed to the NIH Office of Extramural Research (OER) webmaster contact listed in the notice.

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